follow-up · neuropsychiatric inventory npi (12 item) functional assessment questionnaire symptoms...
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Follow-up
Barcelona
Brescia
Duisburg-Essen
Leipzig
Lille
Marseille
Toulouse
CENTRE:
Investigator name:
Patient number:
Date:
D D M M Y Y
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Index
Continue or withdrawal
Cognitive History
Medical History
Concomitant medications for symptomatic treatment of dementia
Psychotropic Medications
Other Concomitant Medications
Vital Signs
Physical Examination
Neurological Examination
Geriatric Depression Scale
Clinical Dementia Rating (CDR)
Neuropsychiatric Inventory NPI (12 item)
Functional Assessment Questionnaire
Symptoms Checklist
Adverse Events - Hospitalizations (1)
Adverse Events - Hospitalizations (2)
Comments
Neuropsychological assessment
Biomarker collection
Diagnostic summary
Early Discontinuation / End of Study
Appendix - Excluded medications
Appendix - Adverse event recording
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
New symptoms at the follow-up
Symptoms in chronological orderSign 1,2,3...
__ __ __ __ __ __ __ __ __
Current symptoms
Memory deficitOther cognitive deficit (specify: ___________________________________________)Personality changeTopographic disorientationApraxiaBradycinesiaGait disturbanceFallsOther (specify: ___________________________________________)
Memory deficitOther cognitive deficit (specify: ___________________________________________)Personality changeTopographic disorientationApraxiaBradycinesiaGait disturbanceFallsOther (specify: ___________________________________________)
Memory deficitOther cognitive deficit (specify: ___________________________________________)Personality changeTopographic disorientationApraxiaBradycinesiaGait disturbanceFallsOther (specify: ___________________________________________)
Cognitive history
Continue or withdrawal
Does the patient continue the study?
if no, detail the reason in the End of Study section
yesno
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Is there a change relative to the previous visit?
If yes, fill in the pertinent items
Psychiatric:
______________________________
Neurologic (other than MCI):
______________________________
Depression (date of first episode)
Head, Eyes, Ears, Nose and Throat:
______________________________
Cardiovascular:
______________________________
Hypercholesterolemia
Hypertension
Ischaemic heart disease
Respiratory:
______________________________
Hepatic:
______________________________
Dermatologic-Connective Tissue:
______________________________
Muscoloskeletal:
______________________________
Endocrine-Metabolic:
______________________________
Gastrointestinal:
______________________________
Hematopoietic-Lymphatic:
______________________________
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
Medical history
Year of diagnosisArea/medical condition Ongoing Stable
yesno
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Renal-Genitourinary:
______________________________
Allergies or drug sensitivies:
______________________________
Alcohol Abuse
Drug abuse:
______________________________
Malignancy:
______________________________
Other:
______________________________
__ __ __ __
__ __ __ __
__ __ __ __
__ __ __ __
yes no
yes no
yes no
yes no
yes no
yes no
yes no
yes no
Year of diagnosisArea/medical condition Ongoing Stable
Medical history
__ __ __ __
__ __ __ __
yes no
yes no
yes no
yes no
Concomitant medications for symptomatic treatment of dementia
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Dose
________________
Dose
________________
Dose
________________
Dose
________________
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
D
D
D
D
D
D
D
D
M
M
M
M
M
M
M
M
Y
Y
Y
Y
Y
Y
Y
Y
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
D
D
D
D
D
D
D
D
M
M
M
M
M
M
M
M
Y
Y
Y
Y
Y
Y
Y
Y
Is there change in the medication since the last visit? If yes, fill in the pertinent items.
Yes No
If medication is ongoing, leave end date blank
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Other Concomitant Medications
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Indication
________________
Indication
________________
Indication
________________
Indication
________________
Indication
________________
Indication
________________
Psychotropic medications
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Drug name (trade)
________________
Indication
________________
Indication
________________
Indication
________________
Indication
________________
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
D
D
D
D
D
D
D
D
M
M
M
M
M
M
M
M
Y
Y
Y
Y
Y
Y
Y
Y
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
Start Date
__ __ __ __ __ __
D
D
D
D
D
D
D
D
D
D
D
D
M
M
M
M
M
M
M
M
M
M
M
M
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
D
D
D
D
D
D
D
D
M
M
M
M
M
M
M
M
Y
Y
Y
Y
Y
Y
Y
Y
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
End Date
__ __ __ __ __ __
D
D
D
D
D
D
D
D
D
D
D
D
M
M
M
M
M
M
M
M
M
M
M
M
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Is there change in the medication since the last visit? If yes, fill in the pertinent items. If medication is ongoing, leave end date blank.
Yes No
Is there change in the medication since the last visit? If yes, fill in the pertinent items. If medication is ongoing, leave end date blank.
Yes No
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
01
02
03
04
05
06
07
08
09
10
11
12
Weight
Height
Blood pressure (supine)
Systolic
Diastolic
Pulse (supine)
One leg balance:Is the patient able to stand at least 5 seconds on one leg? (leg of his/her choice).The patient must keep eyes open and shoes on.
Is there a change relative to the previous visit?
If yes, fill in the pertinent items
General appearance
Head, Eyes, Ears,Nose and Throat
Neck
Chest
Heart
Abdomen
Extremities
Edema
Peripheral vascular
Skin and Appendages
Muscoloskeletal
Other
Vital signs
Physical examination
YesNo
__ __ __ Kg
__ __ __ cm
__ __ __ /min
__ __ __ mm Hg
__ __ __ mm Hg
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
abnormal Details: ________________________________normal
yesno
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
01
02
03
04
05
06
07
08
09
10
11
12
13
14
Is there a change relative to the previous visit?
If yes, fill in the pertinent items
Significant Visual Impairment
Significant Auditory Impairment
Tremor
Level of consciousness
Cranial nerves
Motor strength
Cerebellar - Finger to Nose
Cerebellar - Heel to Shin
Sensory
Deep tendon reflexes
Plantar reflexes
Gait
Parkinsonism signs
Other
Neurological examination
abnormal Details: ______________________________normal
present Details: ______________________________absent
present Details: ______________________________absent
present Details: ______________________________absent
abnormal Details: ______________________________normal
abnormal Details: ______________________________normal
abnormal Details: ______________________________normal
abnormal Details: ______________________________normal
abnormal Details: ______________________________normal
abnormal Details: ______________________________normal
abnormal Details: ______________________________normal
abnormal
present
present
Details: ______________________________
Details: ______________________________
Details: ______________________________
normal
absent
absent
yesno
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
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02
03
04
05
06
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08
09
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InstructionsInstruct the subject: “in the next part of this interview, I will ask you questions about your feelings. Some of the questions I will ask you may not apply, and some may make you feel uncomfortable. For each question, please answer “yes” or “no”, depending on how you have been feeling in the past week, including today.”
Are you basically satisfied with your life?
Have you dropped many of your activities and interests?
Do you feel that your life is empty?
Do you often get bored?
Are you hopeful about the future?
Are you bothered by thoughts you can’t get out of your head?
Are you in good spirits most of the time?
Are you afraid that something bad is going to happen to you?
Do you feel happy most of the time?
Do you often feel helpless?
Do you often get restless and fidgety?
Do you prefer to stay at home, rather than going out and doing new things?
Do you frequently worry about the future?
Do you feel you have more problems with memory than most?
Do you think it is wonderful to be alive now?
Do you often feel downhearted and blue?
Do you feel pretty worthless the way you are now?
Do you worry a lot about the past?
Do you find life very exciting?
Is it hard for you to get started on new projects?
Do you feel full of energy?
Do you feel that your situation is hopeless?
Do you think that most people are better off than you are?
Do you frequently get upset over little things?
Do you frequently feel like crying?
Do you have trouble concentrating?
Do you enjoy getting up in the morning?
Do you prefer to avoid social gatherings?
Is it easy for you to make decisions?
Is your mind as clear as it used to be?
Geriatric depression scale
Symptoms YES NO
0 1
1 0
1 0
1 0
0 1
1 0
0 1
1 0
0 1
1 0
1 0
1 0
1 0
1 0
0 1
1 0
1 0
1 0
0 1
1 0
0 1
1 0
1 0
1 0
1 0
1 0
0 1
1 0
0 1
0 1
TOTAL SCORE
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Clinical Dementia Rating (CDR)
Indicate the appropriate level for each domain
none0
questionable0.5
mild1
moderate2
severe3
Memory
No memory loss or slight inconsistent forgetfulness.
Consistent slight forget-fulness; partial recollec-tion of events; “benign” forgetfulness.
Moderate memory loss; more marked for recent events; defect interferes with everyday activities.
Severe memory loss; only highly learned material retained; new material rapidly lost.
Severe memory loss;only fragments remain.
Orientation
Fully oriented. Fully oriented except for slight difficulty with time relationships.
Moderate difficulty with time relationships; oriented for place at examination; may have geographic disorienta-tion elsewhere.
Severe difficulty with time relationships; usu-ally disoriented to time, often to place.
Oriented to person only.
Judgment & Problem Solving
Solves everyday problems & handles business & financial affairs well; judgment good in relation to past performance.
Slight impairment in solv-ing problems, similarities, and differences.
Moderate difficulty in handling problems, simi-larities, and differences; social judgment usually maintained.
Severely impaired in handling problems, simi-larities, and differences; social judgment usually impaired.
Unable to make judg-ments or solve problems.
Community Affairs
Independent function at usual level in job, shopping, volunteer and social groups.
Slight impairment in these activities.
Unable to function independently at these activities although may still be engaged in some; appears normal to casual inspection.
No pretence of independ-ent function outside home. Appears well enough to taken to func-tions outside a family home.
No pretence of independ-ent function outside home.Appears too ill to be taken to functions out-side a family home.
Home & Hobbies
Life at home, hobbies, and intellectual interests well maintained.
Life at home, hobbies, and intellectual interests slightly impaired.
Mild but definite impair-ment of function at home; more difficult chores abandoned; more complicated hobbies and interests abandoned.
Only simple chores preserved; very restricted interests, poorly maintained.
No significant function in home.
Personal Care
Fully capable of self-care. Needs prompting. Requires assistance in dressing, hygiene, keep-ing of personal effects.
Requires much help with personal care; frequent incontinence.
Fully capable of self-care
TOTAL SCORE:
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Delusions
Hallucinations
AgitationAgression
DepressionDysphoria
Anxiety
ElationEuphoria
ApathyIndifference
Disinhibition
IrritabilityLability
Aberrant motorbehaviour
Sleep
Appetite andeating disorders
TOTAL SCORE: __ __
Scoring Summary
For each domain:If a domain is absent, tick the “0”. If a domain is present, tick one score each for Frequency and Severity.Tick one score for Distress.
Neuropsychiatric Inventory NPI (12 item)
n/a absent frequency severity distress
10 1 12 2 23 3 3 4 54
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Writing checks, paying bills,or balancing checkbook
Assembling tax records,business affairs, or other papers
Shopping alone for clothes,household necessities, or groceries
Playing a game of skill such as bridge or chess, working on a hobby
Heating water, making a cup of coffee,turning off the stove
Preparing a balanced meal
Keeping track of current events
Paying attention to andunderstanding a TV program,book, or magazine
Remembering appointments,family occasions, holidays,medications
Travelling out of the neighbourhood,driving, or arranging to takepublic transportation
TOTAL SCORE: __ __
Instructions:Select the most accurate representation of the participant’s level of ability to perform each activity over the preceding four weeks, based on the Study Partner’s assessment.
Functional Assessment Questionnaire
0 normal0 never did, but could do now
1 never did, would have difficulty now1 has difficulty, but does by self
2 requires assistance3 dependent
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
InstructionsConsidering the preceding six months, check “Absent” or “Present” for each symptom listed below.If “Present,” in the “Details” provide the required information.
Nausea
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
Symptoms Checklist
01
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
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Vomiting
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
02
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Diarrhoea
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
03
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Constipation
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
04
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place.A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Abdominal discomfort
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
05
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Sweating
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
06
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Dizziness
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
07
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Low energy
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
08
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Drowsiness
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
09
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Blurred vision
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
10
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Headache
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
11
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Dry mouth
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
12
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Shortness of breath
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
13
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Coughing
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
14
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Palpitations
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
15
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Chest pain
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
16
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Urinary discomfort (e.g. burning)
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
17
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Urinary frequency
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
18
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Ankle swelling
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
19
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Muscoloskeletal pain
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
20
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Rash
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
21
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
insomnia
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
22
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Depressed mood
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
23
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Crying
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
24
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Elevated mood
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
25
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Wandering
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
26
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Fall
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
27
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Other
Description of Symptom
_______________________________________________________
Severity
Chronicity
Date of OnsetIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the symptom ongoing?
28
AbsentPresent
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
MildModerateSevere
Single occurrenceIntermittentPersistent
Day
Day
Month
Month
Year
Year
Symptoms Checklist
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
InstructionsThe following should be reported as Adverse Events: New symptoms. Previous symptoms that have worsened in chronicity or severity. If a diagnosis has been made, enter the diagnosis name under Event. Any symptoms associated with the diagnosis should be recorded in the Comments section of this form. Do not record associated symptoms as separate Adverse Events. At each visit, the Participant should be asked about the status of each Adverse Event.If no adverese events are reported, leave this section blank.Print more copies of this section if necessary.
AE N° Examination date
__ __ __ __ __ __ __ __ __ __ __
Event (Diagnosis or Symptom if diagnosis is not known)If a diagnosis is reported here, DO NOT report the associated symptoms as separate Adverse Events. Record associated symptoms under the Comments section of this form. * If an event description can be clarified with a keyword, please include that in parenthesis in the Event field (Example: “repeatedly combs hair (behaviour)”)
(_______________________________________________________________________________________________)
Check here if:
Onset DateIf Month and/or Day are unknown, enter ‘--’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the event ongoing?
Is the event a worsening of previous symptoms?
Severity Chronicity
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
YesNo
MildModerateSevere
Single occurrenceIntermittentPersistent
Month
Day
Day
Day
Month
Month
Year
Year
Year
Adverse Events - Hospitalization
this symptom was reported on the Baseline Symptoms Checklist,but has worsened in chronicity or severity.
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Adverse Events - Hospitalization
Serious?If yes, refer to SOP GEST06 Management of SAE and send the SAE form within 24h of SAE occurrence to the sponsor by fax (in Italy IRCCS-FBF: number ++39303501592, in other countries Qualissima: number 0033488151440)
Serious Adverse Event Reported By:
__________________________________________________________________
Reason for Qualifying as Serious Adverse Event:
__________________________________________________________________
Life-threatening?If Yes, Serious must also be answered Yes.
Related to Imaging Procedure?
Related to Lumbar Puncture?
Related to other procedures of the study? (specify: _________________________________________________)
Concurrent Medication Prescribed or Changed?If Yes, update other concomitant medication section and put the AE number as treatment indication.
Did this event occur while the participant was being hospitalized for another event?
If Yes, did this event prolong hospitalization?If Yes, Serious must also be answered Yes.
YesNo
YesNo
YesNo
DefinitelyPossiblyNot Related
DefinitelyPossiblyNot Related
DefinitelyPossiblyNot Related
YesNo
YesNo
No Yes - OutpatientYes - Inpatient
If No, did this event require hospitalization?If Inpatient, Serious must be answered Yes.NOTE: All medications received during hospitalization must be reported on the Other Concomitant Medication section.
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
YesNo
Date of death
__ __ __ __ __ __ __ __
If Outpatient, provide the date of visit
__ __ __ __ __ __ __ __
If Inpatient, provide the date of hospitalization
Admit Date
__ __ __ __ __ __ __ __
Admit Diagnosis
________________________________________________________________________________________________
Discharge Date
__ __ __ __ __ __ __ __
Discharge Diagnosis
________________________________________________________________________________________________
Did this event result in death?If Yes, Serious must also be answered Yes
Adverse Events - Hospitalization
Day
Day
Day
Month
Month
Month
Year
Year
Year
Day Month Year
Cause of death:
____________________________________________________________________________________________________________________________________________________________________________________
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Adverse Events - Hospitalization
InstructionsThe following should be reported as Adverse Events: New symptoms. Previous symptoms that have worsened in chronicity or severity. If a diagnosis has been made, enter the diagnosis name under Event. Any symptoms associated with the diagnosis should be recorded in the Comments section of this form. Do not record associated symptoms as separate Adverse Events. At each visit, the Participant should be asked about the status of each Adverse Event.If no adverese events are reported, leave this section blank.Print more copies of this section if necessary.
AE N° Examination date
__ __ __ __ __ __ __ __ __ __ __
Event (Diagnosis or Symptom if diagnosis is not known)If a diagnosis is reported here, DO NOT report the associated symptoms as separate Adverse Events. Record associated symptoms under the Comments section of this form. * If an event description can be clarified with a keyword, please include that in parenthesis in the Event field (Example: “repeatedly combs hair (behaviour)”)
(_______________________________________________________________________________________________)
Check here if:
Onset DateIf Month and/or Day are unknown, enter ‘--’ in their place. A valid year must be provided.
__ __ __ __ __ __ __ __
Is the event ongoing?
Is the event a worsening of previous symptoms?
Severity Chronicity
YesNo
Date CeasedIf Month and/or Day is unknown, enter ‘ - - ’ in their place. A valid year must be provided.If Event is ongoing, leave Cease Date blank.
__ __ __ __ __ __ __ __
YesNo
MildModerateSevere
Single occurrenceIntermittentPersistent
Month
Day
Day
Day
Month
Month
Year
Year
Year
this symptom was reported on the Baseline Symptoms Checklist,but has worsened in chronicity or severity.
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Adverse Events - Hospitalization
Serious?If yes, refer to SOP GEST06 Management of SAE and send the SAE form within 24h of SAE occurrence to the sponsor by fax (in Italy IRCCS-FBF: number ++39303501592, in other countries Qualissima: number 0033488151440)
Serious Adverse Event Reported By:
__________________________________________________________________
Reason for Qualifying as Serious Adverse Event:
__________________________________________________________________
Life-threatening?If Yes, Serious must also be answered Yes.
Related to Imaging Procedure?
Related to Lumbar Puncture?
Related to other procedures of the study? (specify: _________________________________________________)
Concurrent Medication Prescribed or Changed?If Yes, update other concomitant medication section and put the AE number as treatment indication.
Did this event occur while the participant was being hospitalized for another event?
If Yes, did this event prolong hospitalization?If Yes, Serious must also be answered Yes.
YesNo
YesNo
YesNo
DefinitelyPossiblyNot Related
DefinitelyPossiblyNot Related
DefinitelyPossiblyNot Related
YesNo
YesNo
No Yes - OutpatientYes - Inpatient
If No, did this event require hospitalization?If Inpatient, Serious must be answered Yes.NOTE: All medications received during hospitalization must be reported on the Other Concomitant Medication section.
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
YesNo
Date of death
__ __ __ __ __ __ __ __
If Outpatient, provide the date of visit
__ __ __ __ __ __ __ __
If Inpatient, provide the date of hospitalization
Admit Date
__ __ __ __ __ __ __ __
Admit Diagnosis
________________________________________________________________________________________________
Discharge Date
__ __ __ __ __ __ __ __
Discharge Diagnosis
________________________________________________________________________________________________
Did this event result in death?If Yes, Serious must also be answered Yes
Adverse Events - Hospitalization
Day
Day
Day
Month
Month
Month
Year
Year
Year
Day Month Year
Cause of death:
____________________________________________________________________________________________________________________________________________________________________________________
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Use comments section to clarify vague or problematic symptoms such as dizziness, chest pain, abdominal discomfort or the circumstances surrounding falls and trauma. If the circumstances of a fall or trauma reveal additional AEs or symptoms such as light-headedness, poor balance, visual disturbance, etc., record these as additional AEs and briefly describe the scenario in the comments section under one of the related symptoms.
Comments
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
DOA: date of administration - TOB: time of beginning - TOE: time of end
Neuropsychological assessment
ADAS-COG DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Word recall trial 1
Word recall trial 2
Word recall trial 3
Command
Constructional praxis
Delayed Word-recall
Naming Objects/Fingers
Ideational Praxis
Orientation
Word Recognition
sco
re Remembering test instructions
NoneVery mildMildModerateModerately severeSevere
Word finding difficulty
NoneVery mildMildModerateModerately severeSevere
Comprehension
NoneVery mildMildModerateModerately severeSevere
Spoken language ability
NoneVery mildMildModerateModerately severeSevere
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
Number cancellation
Number of targets hit
Number of errors
Number of times reminded of task
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
AVLT DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Immediate recall
Delayed recall
Recognition
Clock Drawing Test DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Clock drawing
Clock copying
Trail Making Test DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Score
Errors of Commission
Errors of Omission
Score
Errors of Commission
Errors of Omission
Neuropsychological assessment
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
pa
rt A
pa
rt B
score
raw score corrected score
raw score corrected score
raw score corrected score
raw score corrected score
score
score
score
score
sco
re
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
WAIS-R Digit Symbol Substitution Test DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Total score
Boston Naming Test DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Total score
Digit Span Forward DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Total score
Digit Span Backward DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Total score
Neuropsychological assessment
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
raw score corrected score
raw score corrected score
raw score corrected score
raw score corrected score
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Category fluency test DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Total score
Letter fluency test DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Total score raw score corrected score
raw score corrected score
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
Neuropsychological assessment
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
Mini Mental State Examination DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Orientation
Immediate recall
Attention and calculation
Delayed recall
Naming
Repetition
Command
Reading
Writing
Construction
TOTAL SCORE
sco
re
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
Neuropsychological assessment
CANTAB DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Motor Control Task (MOT) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Reaction Time (RTI) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Five choice movement time
Five choice reaction time
Delayed Matching to Sample (DMS) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Percent correct (all delays)
Percent correct (simultaneous)
Prob error given error
Paired Associate Learning (PAL) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Total errors (adjusted)
Total errors (6 shapes, adjusted)
Spatial Working Memory (SWM) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Between errors
Strategy
Rapid Visual Information Processing (RVP) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Score
Pattern Recognition Memory (PRM) - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
immediate - percent correct
delayed - percent correct
Spatial Recognition Memory - doa: __ __ / __ __ / __ __ __ __ tob: __ __ : __ __ toe: __ __ : __ __
Percent correct
Logical Memory DOA: __ __ / __ __ / __ __ __ __ TOB: __ __ : __ __ TOE: __ __ : __ __
Immediate recall total score
Delayed recall total score
raw score corrected score
raw score corrected score
sco
resc
ore
sco
resc
ore
sco
re
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
If the test or a subtest has not been administered, sign N.A. in the corresponding score box and check one:
Not done (for reasons other than physical/cognitive)Patient refusedPatient unable for physical reasonsPatient unable for cognitive reasons
Biomarker collection
MR scan
Done
Not done Reason: ______________________________________________
Not scheduled because of visit
Not scheduled because of centre
Blood
Done ID: _ / _ _ _ / _ _ / _ / _ _ / _ _ _ / _ _ _ / _ _ / _ _ _ _
Not done Reason: ______________________________________________
Not scheduled because of visit
Not scheduled because of centre
CSF
Done ID: _ / _ _ _ / _ _ / _ / _ _ / _ _ _ / _ _ _ / _ _ / _ _ _ _
Not done Reason: ______________________________________________
Not scheduled because of visit
Not scheduled because of centre
EEG
Done
Not done Reason: ______________________________________________
Not scheduled because of visit
Not scheduled because of centre
Actigraphy
Done
Not done Reason: ______________________________________________
Not scheduled because of visit
Not scheduled because of centre
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
01
02
Instructions:This form should be completed by a physician at every in-clinic visit to confirm the participant’s current diagnosis and whether a conversion has occurred.
Date form completed
__ __ __ __ __ __ __ __
Has there been a conversion to dementia?
In the case of patient discontinuation from the study, detail the reason:
In case of early discontinuation, fax this leaf to YOUR sponsor:
In Italy, address it to IRCCS-FBF (fax number 0039 030 350 159 2)
In other countries, address to Qualissima (fax number 0033 488 151 440)
Diagnostic summary
Early Discontinuation / End of Study
YesNo
Day Month Year
If Yes
Withdrawal of consent(in this case, refer to SOP GEST08 Human sample management to manage biological samples of patient)
Withdrawal because of investigator decisiondetail reason: ____________________________________________________________________________
Occurrence of an adverse event which need the stop of study(fill in the AE/SAE section)
Occurrence of an exclusion criteriadetail: __________________________________________________________________________________
Progression to dementia (fill in the Diagnostic summary section)
Otherdetail: __________________________________________________________________________________
Scheduled/normal end of the study
Date of patient discontinuation:
__ __ __ __ __ __ __ __
Alzheimer’s diseaseother dementia (____________________________________________)
Day Month Year
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
EXCLUDED MEDICATIONS
PERMITTED MEDICATIONS
Change in Medication After Enrolment
Antidepressants with anti-cholinergic properties are excluded.Regular use of narcotic analgesics (>2 doses per week) within 4 weeks of screening.Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).Diuretic drugs should not be started or discontinued within 4 weeks prior to screening. Any change in diuretic medication during the study should be reported.
Cholinesterase inhibitors and memantine are permitted if the dose is stable for 4weeks prior to screening.Use of estrogen and estrogen-like compounds is allowed if the dose has been stable for 4 weeks prior to screening.Use of vitamin E is allowed if the dose has been stable for 4 weeks prior to screening (no cap on amount allowed).
Exceptions to these criteria may be considered on a case-by-case basis at the discretion of the Protocol PI (Dr. Frisoni).
Any change in medication (including dose or frequency) should be recorded on the ‘Concurrent Medications Log’ for the visit it is reported. If a subject begins an excluded medication, the site must document this by requesting an exception from the Protocol PI (Dr. Frisoni). If a subject begins a cholinesterase inhibitor or memantine after being approved for enrolment into the study, this should be documented by completing an additional comment form describing the reason for the protocol deviation.
Appendix - Excluded medications
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Case Report Form WP5 / P001 / _ _ / _ _ / T_ _
Please note: This is not a complete list of excluded medications.For drugs not on this list, query the Study PI (Dr. Frisoni).
NARCOTIC ANALGESICS: Not allowed within 4 weeks prior to screening
General name:
NEUROLEPTICS: Not allowed within 4 weeks prior to screening
General name:
ANTICHOLINERGIC AGENTS: Not allowed within 4 weeks prior to screening
General name:
ANTIPARKINSONIAN MEDICATIONS: Not allowed within 4 weeks prior to screening
General name:
Oxycodone/AcetaminophenOxycodone/AspirinPropoxyphene Darvon and its variationsNarcotics that contain codeine or morphine
ChlorpromazineFluphenazineLoxapinePerphenazineThioridazineThiothixeneTrifluoperazineClozapineHaloperidol
Use of followings is permitted if dose is stable for 4 weeks prior to visit
AripiprazoleOlanzapineQuetiapineRisperidone (up to 2 mg/die)Ziprasidone
AmantadineBenztropineCyproheptadineDicyclomineDiphenhydramineDiphenoxylate with atropineHydroxyzineHyoscyamineMeclizineProchlorperazineTrihexyphenidylTrimethobenzamide
BromocriptineSelegilineLevodopaPergolidePramipexole
Appendix - Excluded medications
LIST OF EXCLUDED MEDICATIONS
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INVESTIGATIONAL DRUGS: Not allowed within 4 weeks prior to screening
SEDATIVES / BENZODIAZEPINES: Not allowed within 4 weeks prior to screening
General name:
ANTIHYPERTENSIVE AGENTS WITH FREQUENT CNS SIDE-EFFECTS:Not allowed 4 weeks prior to screening
General name:
ANTIDEPRESSANTS: Not allowed within 4 weeks prior to screening
General name:
ChlordiazepoxideClonazepamDiazepamFlurazepamMeprobamateTriazolam
Allowed if on stable doses 4 weeks prior to screening:
AlprazolamBuspironeChloral HydrateLorazepamOxazepamTemazepamTrazodoneZaleplonZolpidem
Clonidine
AmitriptylineAmoxapineClomipramineDesipramineDoxepinImipramineIsocarboxazideLithiumMaprotilineNortriptylinePhenelzineProtriptylineTranylcypromineTrimipramine
Use of the following is permitted if dose is stable 4 weeks prior to screening:
BupropionWellbutrinCitalopramDuloxetineEscitalopramFluoxetineMirtazapineNefazodoneParoxetineSertralineTrazodoneVenlafaxine
Appendix - Excluded medications
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AE - Definition of Severity:
AE - Relationship to Study Procedure:
SAE - A Serious Adverse Event is one that meets any of the following criteria:
Definition of Life-Threatening Event.An adverse experience is life threatening if, in the view of the investigator, the patient was at immediate risk of death from the reaction as it occurred.Hospitalization.When a patient is hospitalized in an acute care facility, the diagnosis or symptom that prompted hospitalization should be recorded on the serious Adverse Event Form. Visits to the emergency room that do not result in hospital admission should not be recorded as “inpatient.” Serious must always be answered ‘Yes’ when an event requires or prolongs hospitalization.Definition of Disabling / Incapacitating Event. An adverse event is incapacitating or disabling if the event results in a substantial and/or permanent disruption of the patient’s ability to carry out normal life functions.
Mild: Discomfort noticed, but no disruption of normal daily activity. Moderate: Discomfort sufficient to reduce or affect the normal daily activity.Severe: Incapacitating, with inability to work or perform normal daily activity.
Not Related: This category is applicable to those adverse events which, after careful medical consideration at the time of evaluation, are judged to be clearly, and beyond a reasonable doubt, due to extraneous causes (disease, environment, etc.). Additionally, the event does not meet the criteria for relationship to procedures as listed under Possibly Related or Definitely Related.
Possibly Related: This category applies to those adverse experiences in which the connection with the study procedure appears possible and cannot be ruled out with certainty. To be considered Possibly Related, the adverse experience should meet the following two criteria:
Definitely Related: This category applies to those adverse experiences which, after careful medical consideration at the time they are evaluated, are considered, beyond a reasonable doubt, to be related to the study procedure. To be considered Definitely Related, the adverse experience should meet the following criteria:
Fatal or immediately life-threateningCauses permanent or substantial disabilityRequires or prolongs inpatient hospitalization (acute)Congenital anomaly/birth defectIs a cancerSuggests any significant hazard, contraindication, side effect or precaution that may be associated with the use of a study procedureRegarded by the investigator as serious
It follows a reasonable temporal sequence from initiating the procedure. It could not be reasonably explained by the known characteristics of the patient’s clinical state, environmental or toxic factors, or modes of therapy administered (when applicable).
It follows a reasonable temporal sequence from initiating the procedure. It could not be reasonably explained by the known characteristics of the patient’s clinical state, environmental or toxic factors, or modes of therapy administered (when applicable).It follows a known pattern of response to the suspected procedure.
Appendix - Adverse event recording
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