PPMI Study CRF and Assessments

Transcription

1 Study CRF and Assessments For Amendment-3 TAP-PD Version 2.1 This packet contains CRFs from the Clinical Trials Coordination Center (CTCC; PPMI Clinical Core). The CRF and assessment information in this PDF are intended to be used by researchers accessing the PPMI data sets and are not intended for redistribution or to be used as study documents. For assessments that require a licensing fee or permission, the most accurate and available contact information is provided. Should you have any questions regarding these documents please contact us using the link: 06-FEB-2012

2 CRF Table of Contents (Click CRF Name below to link to CRF) Schedule of Activities for: Parkinson Disease (PD) Subjects Healthy Control (HC) Subjects Subjects without Evidence of Dopaminergic Deficit (SWEDD) CRF Name PDF Page Data Category (web location of Data set) Adverse Events Log 88 Medical History Benton Judgment of Line Orientation 43 Non-motor Assessments Clinical Diagnosis and Management Questionnaire (SWEDD) 33 Enrollment Clinical Laboratory Assessments 73 Biospecimen Conclusion of Study participation - TAP-PD 94 Enrollment Conclusion of Study participation - PPMI 87 Enrollment Concomitant Medication Log 86 Medical History CTCC Unique ID 10 NA Current Medical Conditions Log 85 Medical History DaTSCAN imaging 71 Imaging Demographics 7 Subject Characteristics DNA Blood Sample Collection 74 Biospecimen Epworth Sleepiness Scale 51 Non-motor Assessments Family History (PD) 20 Subject Characteristics Geriatric Depression Scale (GDS-15) 56 Non-motor Assessments Hopkins Verbal Learning Test Revised (HVLT) 41 Non-motor Assessments Inclusion/Exclusion Criteria 11 Enrollment Laboratory Procedures (RNA, Urine, Plasma, & Serum sample 76 Biospecimen collection) Letter Number Sequencing 45 Non-motor Assessments Lumbar puncture (CSF collection) 79 Biospecimen MDS-UPDRS (including Hoehn & Yahr) 37 Motor Assessments MDS-UPDRS Part III / Hoehn & Yahr 38 Motor Assessments Medical History (General) 21 Medical History Modified Schwab & England ADL 39 Motor Assessments Montreal Cognitive Assessment (MoCA) 48 Non-motor Assessments

3 MRI (structural) 70 Imaging Neurological Examination (Cranial Nerves) 27 Medical History Neurological Examination (General) 27 Medical History Olfactory Testing (UPSIT) 67 Non-motor Assessments PD Features 18 Medical History Physical Examination (General) 29 Medical History Pregnancy Test 32 Medical History Primary Diagnosis 19 Enrollment QUIP 59 Non-motor Assessments REM Sleep Behavior Questionnaire 52 Non-motor Assessments SCOPA-AUT 62 Non-motor Assessments Semantic Fluency 44 Non-motor Assessments Signature Form (out of window visits) 83 Enrollment Socio-Economics 9 Subject Characteristics State-Trait Anxiety Inventory for Adults (STAI) 61 Non-motor Assessments Subject Site Transfer 89 NA Symbol Digit Modalities Test 46 Non-motor Assessments TAP-PD OPDM assessment (Clinic visits) 93 Motor Assessments TAP-PD OPDM Use Questionnaire 92 Motor Assessments TAP-PD Schedule of Assessments 90 NA TAP-PD Subject Eligibility 91 Enrollment Telephone Visit 17 NA Use of PD Medication and Dose 36 Medical History Vital Signs 31 Medical History Whole Blood Sample 75 Biospecimen

4 Schedule of Activities PARKINSON DISEASE (PD) SUBJECTS Visit Number Level SC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07 T08 V07 T09 V08 T10 T11 V09 T12 V10 T13 T14 V11 T15 V12 T16 Unsched. FNL PW ST Visit Description Months (+30 days) # Visit Confidential Subject Identification Log X Written Informed Consent X Screening/Demographics 02 X Socio-Economics 04 X CTCC Unique ID 06 X Inclusion/Exclusion - Parkinson disease 10 X X Telephone Follow-up 12 X X X X X X X X X X X X X X X X PD Features 14 X Primary Diagnosis 16 X X X X X X X Medical History (General) 18 X Family History (PD) 20 X General Neurological Exam 22 X X X X X X X X d General Physical Exam 24 X Vital Signs 26 X X c X X X X c X X c X X c X X c X X c X c X X Pregnancy Form 28 X X X X X Use of PD Medication 30 X X X X X X X X X X X X X X X MDS-UPDRS/Hoehn & Yahr X X X X X X X X X X X X X X X X X d Modified Schwab and England Activities of Daily Living 32 X X X X X X X X X X X X X X X X X d MDS-UPDRS (Post Dose) b 34 X X X X X X Hopkins Verbal Learning Test Revised 36 X X X X X X X Benton Judgment of Line Orientation X X X X X X X Semantic Fluency 38 X X X X X X X Letter Number Sequencing (PD) 40 X X X X X X X Symbol Digit Modalities Test 42 X X X X X X X Montreal Cognitive Assessment (MoCA) 43 X X X X X X X Epworth Sleepiness Scale 44 X X X X X X X X X REM Sleep Disorder Questionnaire 46 X X X X X X X X X Geriatric Depression Scale (GDS-15) 48 X X X X X X X X X State-Trait Anxiety Inventory for Adults X X X X X X X X X Questionnaire for Impulsive-Compulsive Disorders 50 X X X X X X X X X Scales for Outcome in Parkinson's Disease (SCOPA-AUT) 52 X X X X X X X X X Olfactory Testing (UPSIT) 54 X DNA Sample 56 X Laboratory Procedures 58 X e X X e X X e X X e X X e X X e X X e X e X e Clinical Labs 59 X X X i X X X X X X d Whole Blood Sample 78 X X X X X X X X X X X X X X X Magnetic Resonance Imaging (Structural) 60 X Magnetic Resonance Imaging (DTI) f 60 X X X X X DaTSCAN Imaging 62 X X X X X Lumbar Puncture 64 X X g X X X X X X X h Signature Form 66 X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Adverse Event Log 68 X a X a X a X a X a X a X a X a X a X a Current Medical Conditions Log 70 X X X X X X X X X X X X X X X X Concomitant Medication Log 72 X X X X X X X X X X X X X X X X X Conclusion of Study Participation 74 X X Subject Site Transfer Form 76 If needed a Adverse events will be assessed at the visit and 7 days ± 3 days (phone call) following the visit. b Will be conducted 1hr post treatment for subjects on levodopa or dopamine agonists. c Height and weight also collected. d Conduct as clinically indicated - see protocol Unscheduled Visit. e Biomic urine sample also collected. ST = Symptomatic Therapy PW = Premature Withdrawal FNL= Final f MRI DTI at selected sites only. g Not repeated if ST Visit completed prior to V02. 8/9/2011 h Not repeated depending on when ST visit conducted. I Completed only if not done at Month 9.

5 Visit Number SC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07 T08 V07 T09 V08 T10 T11 V09 T12 V10 T13 T14 V11 T15 V12 T16 Unsched. FNL PW Visit Description Months (+30 days) Level # Visit Confidential Subject Identification Log X Written Informed Consent X Screening/Demographics 02 X Socio-Economics 04 X CTCC Unique ID 06 X Inclusion/Exclusion - Healthy Control 11 X X (review) Telephone Follow-up 12 X X X X X X X X X X X X X X X X Primary Diagnosis 16 X X X X X X X Medical History (General) 18 X Family History (PD) 20 X General Neurological Exam 22 X X X X X X X X d General Physical Exam 24 X Vital Signs 26 X X c X X X X c X X c X X c X X c X X c X c X Pregnancy Form 28 X MDS-UPDRS/Hoehn & Yahr X X X X X X X X d Hopkins Verbal Learning Test Revised 36 X X X X X X X Benton Judgment of Line Orientation X X X X X X X Semantic Fluency 38 X X X X X X X Letter Number Sequencing (PD) 40 X X X X X X X Symbol Digit Modalities Test 42 X X X X X X X Montreal Cognitive Assessment (MoCA) 43 X X X X X X X Epworth Sleepiness Scale 44 X X X X X X X REM Sleep Disorder Questionnaire 46 X X X X X X X Geriatric Depression Scale (GDS-15) 48 X X X X X X X State-Trait Anxiety Inventory for Adults X X X X X X X Questionnaire for Impulsive-Compulsive Disorders 50 X X X X X X X Scales for Outcome in Parkinson's Disease (SCOPA-AUT) 52 X X X X X X X Olfactory Testing (UPSIT) 54 X DNA Sample 56 X Laboratory Procedures 58 X e X X e X X e X X e X X e X X e X X e X e Clinical Labs 59 X X X h X X X X X X d Whole Blood Sample 78 X X X X X X X X X X X X X X Magnetic Resonance Imaging (Structural) 60 X Magnetic Resonance Imaging (DTI) f 60 X X X g DaTSCAN Imaging b 62 X Lumbar Puncture 64 X X X X X X X X Signature Form 66 X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Adverse Event Log 68 X a X a X a X a X a X a X a X a X a Current Medical Conditions Log 70 X X X X X X X X X X X X X X X Concomitant Medication Log 72 X X X X X X X X X X X X X X X X Conclusion of Study Participation 74 X X Subject Site Transfer Form 76 If needed a Adverse events will be assessed at the visit and 7 days ± 3 days (phone call) following the visit. b Screening DAT image maybe conducted up to 7 days prior to BL Visit. PPMI Schedule of Activities HEALTHY CONTROL (HC) SUBJECTS c Height and weight also collected. d Conduct as clinically indicated - see protocol Unscheduled Visit. e Biomic urine sample also collected. PW = Premature Withdrawal FNL= Final f MRI DTI at selected sites only. 8/9/2011 g Only if PW visit done within first 12 months and MRI not done in last 6 months. h Completed only if not done at month 9.

6 Schedule of Activities SWEDD SUBJECTS Visit Number ReSC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07 Unsched. Visit Description Months (+30 days) Level # FNL PW ST Visit Confidential Subject Identification Log X Written Informed Consent X Screening/Demographics 02 X Inclusion/Exclusion - SWEDD 86 X X (review) Telephone Follow-up 12 X X X X X X X Clinical Diagnosis and Management Questionnaire 88 X X X X X X X Medical History (General) 18 X Family History (PD) 20 X General Neurological Exam 22 X X X X X d General Physical Exam 24 X Vital Signs 26 X X c X X X X c X X c X c X X Pregnancy Form 28 X X X Use of PD Medication 30 X X X X X X X X X MDS-UPDRS/Hoehn & Yahr X X X X X X X X X X X d Modified Schwab and England Activities of Daily Living 32 X X X X X X X X X X X d MDS-UPDRS (Post Dose) b 34 X X X Hopkins Verbal Learning Test Revised 36 X X X X Benton Judgment of Line Orientation X X X X Semantic Fluency 38 X X X X Letter Number Sequencing (PD) 40 X X X X Symbol Digit Modalities Test 42 X X X X Montreal Cognitive Assessment (MoCA) 43 X X X X Epworth Sleepiness Scale 44 X X X X X X REM Sleep Disorder Questionnaire 46 X X X X X X Geriatric Depression Scale (GDS-15) 48 X X X X X X State-Trait Anxiety Inventory for Adults X X X X X X Questionnaire for Impulsive-Compulsive Disorders 50 X X X X X X Scales for Outcome in Parkinson's Disease (SCOPA-AUT) 52 X X X X X X Olfactory Testing (UPSIT) 54 X Laboratory Procedures 58 X e X X e X X e X X e X e X e Clinical Labs 59 X X X X X d Whole Blood Sample 78 X X X X X X X X X Magnetic Resonance Imaging (Structural) 60 X Magnetic Resonance Imaging (DTI) f 60 X X X X DaTSCAN Imaging 62 X X Lumbar Puncture 64 X X g X X X X h Signature Form 66 X X X X X X X X X X X X X X X X X X Adverse Event Log 68 X a X a X a X a X a X a Current Medical Conditions Log 70 X X X X X X X X X X Concomitant Medication Log 72 X X X X X X X X X X X Conclusion of Study Participation 74 X X Subject Site Transfer Form 76 If needed a Adverse events will be assessed at the visit and 7 days ± 3 days (phone call) following the visit. b Will be conducted 1hr post treatment for subjects on levodopa or dopamine agonists. c Height and weight also collected. d Conduct as clinically indicated - see protocol Unscheduled Visit. e Biomic urine sample also collected. f MRI DTI at selected sites only. ST = Symptomatic Therapy PW = Premature Withdrawal g Not repeated if ST Visit completed prior to V02. 8/9/2011 h Not repeated depending on when ST visit is conducted. ReSC = Re-Screen FNL = Final

7 SCREENING/DEMOGRAPHICS Complete one form for each subject who has signed consent and is potentially eligible to participate in the study. A. Check box if subject has signed consent B. Date informed consent was signed: B. C. Indicate the enrollment category for this subject: (1 = Parkinson disease, 2 = Healthy Control, 3 = SWEDD) C. 1. Date of birth: 2. Gender (0 = Female of child bearing potential, 1 = Female of non-child bearing potential, 2 = Male) Women who are surgically sterile (hysterectomy or tubal ligation) or post-menopausal (last menstruation was 1 year or more prior to Screening Visit) are considered to be of non-childbearing potential ETHNICITY 3. Do you identify your ethnicity as being Hispanic or Latino (Spanish origin)? (0 = No, 1 = Yes, 2 = Unknown or not reported) RACE 4.1 Do you identify yourself as being American Indian or Alaska Native? (0 = No, 1 = Yes, 2 = Unknown or not reported) 4.2 Do you identify yourself as being Asian? (0 = No, 1 = Yes, 2 = Unknown or not reported) 4.3 Do you identify yourself as being Black or African American? (0 = No, 1 = Yes, 2 = Unknown or not reported) 4.4 Do you identify yourself as being Native Hawaiian or Other Pacifi c Islander? (0 = No, 1 = Yes, 2 = Unknown or not reported) 4.5 Do you identify yourself as being White? (0 = No, 1 = Yes, 2 = Unknown or not reported) 4.6 Do you identify yourself with a race category not specifi ed on this form? (0 = No, 1 = Yes, 2 = Unknown or not reported) If Yes, please specify: Projected Enrollment Date: 5. Copyright 2007 University of Rochester. All Rights Reserved. (11/1/10) 8/9/11 Page 1 of 2

8 SCREENING/DEMOGRAPHICS Referral Source: = Site personnel 30 = Advocacy Organization 02 = PCP 31 = Support Group 80 = Call center 04 = Family or Friend 58 = Clinicaltrials.gov 10 = Newspaper/ 59 = PDtrials.org Magazine Article 11 = Newspaper/ 60 = Specialist Magazine Ad 14 = Radio/TV Ad 99 = Other (specify in comments) 15 = Radio/TV Story 50 = Study Website 16 = Online News/ Blog/Other 17 = Out of Home Ad 53 = Site Website 71 = MJFF Communication 18 = Event 54 = Study Web Ad 72 = Another PD Subject 6a. If referred by a medical professional (02, 60), provide name: 7a. Declined 7b. Reason for declining: 7b. 01 = Confi dentiality issues 07 = Physician advised declining 08 = Enrolled in other study 03 = Protocol too restrictive 09 = Not interested (specify in comments) 04 = Protocol too time intensive 05 = Travel requirements 11 = Risks of Protocol 06 = Family advised declining 12 = Did not agree to lumbar puncture 99 = Other (specify in comments) 8a. Excluded 8b. Reason for exclusion: 01 = Exclusionary medication 08 = Enrolled in other study 02 = Other medical, psychiatric, or surgical condition 03 = Disease too advanced 04 = Dx uncertain 06 = Did not meet other inclusion criteria (specify in comments) 12 = Abnormal Safety Labs 13 = SPECT Scan 99 = Other (specify in comments) 9. Comments: 8b. Copyright 2007 University of Rochester. All Rights Reserved. (11/1/10) 8/9/11 Page 2 of 2

9 SOCIO-ECONOMICS INITIALS VISIT DATE 1. Subject Education (number of years) Handedness (1 = Right, 2 = Left, 3 = Mixed) 4. Copyright 2006 University of Rochester. All Rights Reserved. (6/26/09) 5/6/10 Page 1 of 1

10 CTCC UNIQUE ID INITIALS VISIT DATE 1. CTCC 9 digit Unique ID: If you have previously generated a Unique ID for this subject and have it on fi le, please enter it from your records. If you have not yet generated a Unique ID for this subject, please go to the following website to do so: If you have previously generated a Unique ID for this subject, and do not have it on fi le, you can go to the website to reconstruct it. Please note - you will need to enter the information exactly as it was entered before to recreate the same Unique ID. Copyright 2006 University of Rochester. All Rights Reserved. (9/19/08) 5/6/10 Page 1 of 1

11 INCLUSION/EXCLUSION - PARKINSON DISEASE (Amend 3) INITIALS SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes) VISIT DATE 1. Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia A diagnosis of Parkinson disease for 2 years or less at Screening Hoehn and Yahr Stage I or II at Baseline Not expected to require PD medication within at least 6 months from Baseline Male or female age 30 years or older at time of PD diagnosis. 6. Confi rmation from imaging core that screening dopamine transporter SPECT scan is consistent with dopamine transporter defi cit. 7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 9. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Women of childbearing potential must have a negative urine pregnancy test at the Screening visit. Urine pregnancy screening is not required for women who are surgically sterile or post-menopausal (last menstruation greater than or equal to 12 months prior to Screening) To be ELIGIBLE for study participation ALL answers to items 1-8 must be 1 = Yes and item 9 must be 1 = Yes if female of child bearing potential SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) 1. Atypical PD syndromes due to either drugs (e.g., metoclopramide, fl unarizine, neuroleptics) or metabolic disorders (e.g., Wilson s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy). 2. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, (e.g. selegiline, rasagiline) amantadine or other PD medication. Copyright 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/ Page 1 of 2

12 INCLUSION/EXCLUSION - PARKINSON DISEASE (Amend 3) SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) Continued 3. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline. 4. Has taken levopdopa or dopamine agonists prior to Baseline for more than a total of 60 days. 5. A clinical diagnosis of dementia as determined by the investigator. 6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically signifi cant coagulopathy or thrombocytopenia. 9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. 10. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). 11. Previously obtained MRI scan with evidence of clinically signifi cant neurological disorder (in the opinion of the Investigator) To be ELIGIBLE for study participation ALL answers to items 1-11 must be 0 = No To discuss questionable subject eligibility, call the CTCC Project Manager. Copyright 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/11 PROTOCOL DEVIATION CODE Page 2 of 2

13 INCLUSION/EXCLUSION - HEALTHY CONTROL (Amend 2) INITIALS VISIT DATE SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes) 7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 9. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit. Urine pregnancy screening is not required for women who are surgically sterile or post-menopausal (last menstruation greater than or equal to 12 months prior to Screening) Male or female age 30 years or older at Screening. 10. To be ELIGIBLE for study participation ALL answers to items 7, 8 and 10 must be 1 = Yes, and item 9 must be 1 = Yes if female of child bearing potential SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) 6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically signifi cant coagulopathy or thrombocytopenia. 9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). 10. Copyright 2006 University of Rochester. All Rights Reserved. (2/25/10) 7/8/11 Page 1 of 2

14 INCLUSION/EXCLUSION - HEALTHY CONTROL (Amend 2) SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) Continued 11. Previously obtained MRI scan with evidence of clinically signifi cant neurological disorder (in the opinion of the Investigator) Current or active clinically signifi cant neurological disorder (in the opinion of the Investigator) First degree relative with idiopathic PD (parent, sibling, child) MoCA score less than or equal to To be ELIGIBLE for study participation ALL answers to items 6-15 must be 0 = No To discuss questionable subject eligibility, call the CTCC Project Manager. Copyright 2006 University of Rochester. All Rights Reserved. (2/25/10) 7/8/11 PROTOCOL DEVIATION CODE Page 2 of 2

15 INCLUSION/EXCLUSION - SWEDD (Amend 3) INITIALS SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes) VISIT DATE 1. Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia A diagnosis of Parkinson disease for 2 years or less at Screening Hoehn and Yahr Stage I or II at Baseline Not expected to require PD medication within at least 6 months from Baseline Male or female age 30 years or older at time of PD diagnosis. 7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 9. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Women of childbearing potential must have a negative urine pregnancy test at the Screening visit. Urine pregnancy screening is not required for women who are surgically sterile or post-menopausal (last menstruation greater than or equal to 12 months prior to Screening). 11. Confi rmation from imaging core that screening dopamine transporter SPECT scan is consistent with no dopamine transporter defi cit To be ELIGIBLE for study participation ALL answers to items 1-5, 7, 8 and 11 must be 1 = Yes and item 9 must be 1 = Yes if female of child bearing potential SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) 1. Atypical PD syndromes due to either drugs (e.g., metoclopramide, fl unarizine, neuroleptics) or metabolic disorders (e.g., Wilson s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy). 2. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, (e.g. selegiline, rasagiline) amantadine or other PD medication. Copyright 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/ Page 1 of 2

16 INCLUSION/EXCLUSION - SWEDD (Amend 3) SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) Continued 3. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline. 4. Has taken levopdopa or dopamine agonists prior to Baseline for more than a total of 60 days. 5. A clinical diagnosis of dementia as determined by the investigator. 6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically signifi cant coagulopathy or thrombocytopenia. 9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. 10. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). 11. Previously obtained MRI scan with evidence of clinically signifi cant neurological disorder (in the opinion of the Investigator) To be ELIGIBLE for study participation ALL answers to items 1-11 must be 0 = No To discuss questionable subject eligibility, call the CTCC Project Manager. Copyright 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/11 PROTOCOL DEVIATION CODE Page 2 of 2

17 TELEPHONE FOLLOW-UP T INITIALS VISIT DATE INSTRUCTIONS: To be used for Interim Telephone call to subject. 1. Was contact made during this telephone call? (0 = No, 1 = Yes) 1. 1a. If No (0), please indicate the reason: 1 = phone disconnected 2 = multiple messages left on answering machine were not returned 3 = subject moved - unable to locate 1a. 5 = other (specify) If new contact information obtained for the subject (e.g., change of phone number or address) document the new contact information in the subject s study record and Confi dential Subject Identifi cation Log. During the telephone contact: Review and record concomitant medications Review and record adverse events 2. Comments: Copyright 2008 University of Rochester. All Rights Reserved. 2/16/11 Page 1 of 1

18 PD FEATURES INITIALS VISIT DATE 1. Date of fi rst symptom onset per the subject: 1. MM YYYY 2a. Date of Parkinson s disease diagnosis: (Leave blank if patient has a diagnosis other than PD.) 2b. 1 = Actual (ACT), 2 = Day Estimated (Day), 3 = Mon/Day Est. (MD), 4 = Month Est. (Mon) 2a. 2b. 3. Were the following symptoms present at the time of diagnosis? (0 = No, 1 = Yes, U = Unknown) 3a. Resting Tremor 3a. 3b. Rigidity 3b. 3c. Bradykinesia 3c. 3d. Postural instability 3d. 3e. Other, specify: 3e. 4. Side predominantly affected at onset (1 = Left, 2 = Right, 3 = Symmetric) 4. Copyright 2006 University of Rochester. All Rights Reserved. (10/17/07) 5/6/10 Page 1 of 1

19 PRIMARY DIAGNOSIS INITIALS VISIT DATE 2. Most likely primary diagnosis: 01 = Idiopathic PD 02 = Alzheimer s disease 03 = Chromosome-17 frontotemporal dementia 04 = Corticobasal degeneration 05 = Dementia with Lewy bodies 06 = Dopa-responsive dystonia 07 = Essential tremor 08 = Hemiparkinson/hemiatrophy syndrome 09 = Juvenile autosomal recessive parkinsonism 10 = Motor neuron disease with parkinsonism 11 = Multiple system atrophy 12 = Neuroleptic-induced parkinsonism 13 = Normal pressure hydrocephalus 14 = Progressive supranuclear palsy 15 = Psychogenic illness 16 = Vascular parkinsonism 17 = No PD nor other neurological disorder 18 = Spinocerebellar Ataxia (SCA) 97 = Other neurological disorder(s) (specify) 2. Examiner STAFF CODE Copyright 2006 University of Rochester. All Rights Reserved. (10/17/07) 5/6/10 Page 1 of 1

20 FAMILY HISTORY (PD) INITIALS VISIT DATE NUMBER of FAMILY MEMBERS NUMBER with PD or PARKINSONISM 1. Biological Mother Biological Father Full Siblings Half Siblings Maternal Grandparents Paternal Grandparents Maternal Aunts and Uncles Paternal Aunts and Uncles Children Copyright 2005 PD-DOC and the NIEHS/Parkinson Institute Working Group on Environmental Risk Questionnaires. (10/16/07) 1/26/11 Page 1 of 1

21 MEDICAL HISTORY (GENERAL) INITIALS VISIT DATE NOTE: This form starts with question 1d. 1. Has the subject ever had a signifi cant disorder, disease or surgery of the following systems? CATEGORIES Dermatological Enter all significant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in Additional Information category and indicate which category the condition falls under. DO NOT ABBREVIATE = Active 2 = Resolved Year of Diagnosis 1d. History? (0 = None, 1 = Yes) e. Ophthalmological History? (0 = None, 1 = Yes) f. ENT History? (0 = None, 1 = Yes) Copyright 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 1 of 6

22 MEDICAL HISTORY (GENERAL) CATEGORIES Pulmonary Enter all significant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in Additional Information category and indicate which category the condition falls under. DO NOT ABBREVIATE = Active 2 = Resolved Year of Diagnosis 1g. History? (0 = None, 1 = Yes) h. Cardiovascular History? (0 = None, 1 = Yes) i. Gastrointestinal History? (0 = None, 1 = Yes) Copyright 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 2 of 6

23 MEDICAL HISTORY (GENERAL) CATEGORIES Hepatobiliary Enter all significant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in Additional Information category and indicate which category the condition falls under. DO NOT ABBREVIATE = Active 2 = Resolved Year of Diagnosis 1j. History? (0 = None, 1 = Yes) k. Renal History? (0 = None, 1 = Yes) l. Gynecologic/ Urologic History? (0 = None, 1 = Yes) 4. Copyright 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 3 of 6

24 MEDICAL HISTORY (GENERAL) CATEGORIES Musculoskeletal Enter all significant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in Additional Information category and indicate which category the condition falls under. DO NOT ABBREVIATE = Active 2 = Resolved Year of Diagnosis 1m. History? (0 = None, 1 = Yes) n. Metabolic/ Endocrine History? (0 = None, 1 = Yes) 4. 1o. Hemato/Lymphatic History? (0 = None, 1 = Yes) Copyright 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 4 of 6

25 MEDICAL HISTORY (GENERAL) CATEGORIES Enter all significant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in Additional Information category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1 = Active 2 = Resolved Year of Diagnosis 1p. Neurologic (other than disease under study) History? (0 = None, 1 = Yes) 4. 1q. Psychiatric History? (0 = None, 1 = Yes) r. Allergy/ Immunologic Please note drug allergies History? (0 = None, 1 = Yes) 4. Copyright 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 5 of 6

26 MEDICAL HISTORY (GENERAL) Other CATEGORIES Enter all significant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in Additional Information category and indicate which category the condition falls under. DO NOT ABBREVIATE = Active 2 = Resolved Year of Diagnosis 1s. History? (0 = None, 1 = Yes) Additional Information If there are more than 4 medical history items per category, enter in Additional information category below. Indicate which category the condition falls under (e.g., 1a, 1b, etc.). DO NOT ABBREVIATE. Category A. B. C. D. E. F. G. Copyright 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 6 of 6

27 GENERAL NEUROLOGICAL EXAM INITIALS VISIT DATE Cranial Nerves 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test 1a. I 1a. 1b. II 1b. 1c. III, IV, VI 1c. 1d. V 1d. 1e. VII 1e. 1f. VIII 1f. 1g. IX, X 1g. 1h. XI 1h. 1i. XII 1i. Motor System 2. Muscle Strength 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test 2a. RIGHT ARM 2b. LEFT ARM 2c. RIGHT LEG 2d. LEFT LEG 2a. 2b. 2c. 2d. Copyright 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10 Page 1 of 2

28 GENERAL NEUROLOGICAL EXAM Coordination 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test Finger-to-nose 3a. RIGHT HAND 3a. 3b. LEFT HAND Heel-to-shin 3c. RIGHT LEG 3b. 3c. 3d. LEFT LEG 3d. Sensory 4. Sensation (pain, light touch, position, vibration) 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test 4a. RIGHT ARM 4a. 4b. LEFT ARM 4c. RIGHT LEG 4b. 4c. 4d. LEFT LEG 4d. Reflexes 5. Muscle Stretch Refl exes 0 = Absent, 1 = Hypoactive, 2 = Normal, 3 = Hyperactive, no clonus, 4 = Hyperactive, clonus, 5 = Not tested, 6 = Unable to test If response is 5 or 6, describe briefl y. 5a. RIGHT ARM 5a. 5b. LEFT ARM 5c. RIGHT LEG 5d. LEFT LEG 5b. 5c. 5d. 6. Plantar Response 0 = Flexor, 1 = Extensor, 2 = Indeterminate, 3 = Not tested, 4 = Unable to test If response is 3 or 4, describe briefl y. 6a. RIGHT 6b. LEFT 6a. 6b. Copyright 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10 STAFF CODE Page 2 of 2

29 GENERAL PHYSICAL EXAM INITIALS VISIT DATE ORGAN SYSTEM ABNORMALITIES BY EXAMINATION Use the following Key for items 1-11: 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test 1. Skin Head/Neck/Lymphatic Eyes Ears/Nose/Throat Lungs 5. Copyright 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10 Page 1 of 2

30 GENERAL PHYSICAL EXAM ORGAN SYSTEM ABNORMALITIES BY EXAMINATION Use the following Key for items 1-11: 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test 6. Cardiovascular (including peripheral vascular) Abdomen Musculoskeletal Neurological Psychiatric Other (Specify location and describe.) 11. Copyright 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10 Page 2 of 2

31 VITAL SIGNS INITIALS VISIT DATE 1. Weight (in Kilograms) - Baseline and Annual only Height (in Centimeters) - Baseline and Annual only Temperature (in Celsius) Arm used to measure blood pressure? (1 = Right arm, 2 = Left arm) Supine blood pressure: systolic/diastolic (mmhg) (to be taken after subject has been supine for 1-3 minutes) 6. Supine heart rate (beats per minute) (to be taken after subject has been supine for 1-3 minutes) Standing blood pressure: systolic/diastolic (mmhg) (to be taken after subject has been standing for 1-3 minutes) 10. Standing heart rate (beats per minute) (to be taken after subject has been standing for 1-3 minutes) Comments: Copyright 2004 University of Rochester. All Rights Reserved. (10/17/07) 5/6/10 Page 1 of 1

32 PREGNANCY FORM INITIALS VISIT DATE 1. If female, was pregancy test performed? (0 = No, 1 = Yes) If No, specify in comments. 1a. If the response to question 1 is Yes, is the subject pregnant? (0 = No, 1 = Yes) 1b. Was the urine pregnancy test result confi rmed prior to injection for SPECT scan? (0 = No, 1 = Yes, 2 = Not Applicable) If No, specify in comments. 1. 1a. 1b. NOTE: If pregnant, consult protocol. 2. Comments: Copyright 2004 University of Rochester. All Rights Reserved. (4/24/09)x 6/16/11 Page 1 of 1

33 CLINICAL DIAGNOSIS AND MANAGEMENT QUESTIONNAIRE INITIALS VISIT DATE 1. To what degree are you confi dent that this person has motor signs consistent with a parkinsonian syndrome (PS) (any condition in which there is neurodegeneration of dopaminergic cells in the substantia nigra)? 1. 1 = Motor abnormalities that are likely signs of PS (90-100%) 2 = Motor abnormalities that may be signs of PS (50-89%) 3 = Non-specifi c motor abnormalities (10-49%) 4 = No evidence of parkinsonian motor signs (0-9%) 2. Indicate the following signs on examination that you believe are related to a PS (any condition in which there is neurodegeneration of dopaminergic cells in the substantia nigra). (0 = No, 1 = Yes) 2a. No motor signs consistent with PS 2b. Rest tremor 2c. Rigidity 2d. Bradykinesia 2e. Gait disturbances 2f. Other (specify) 2a. 2b. 2c. 2d. 2e. 2f. 3. Indicate the current most likely clinical diagnosis from one of the categories listed below (choose one): 3. Disorders expected to have a dopamine transporter deficit. 01 = Idiopathic PD 11 = Multiple system atrophy 04 = Corticobasal ganglionic degeneration 14 = Progressive supranuclear palsy 05 = Dementia with Lewy bodies 08 = Hemiparkinsonism/hemiatrophy syndrome Disorders expected to have no dopamine transporter deficit. 02 = Alzheimer disease 13 = Normal pressure hydrocephalus 03 = Chromosome 17 frontotemporal dementia 15 = Psychogenic illness 06 = Dopa-responsive dystonia 16 = Vascular parkinsonism 07 = Essential tremor 17 = No PD nor other neurological disorder 09 = Juvenile autosomal recessive parkinsonism 18 = Spinocerebellar Ataxia (SCA) 10 = Motor neuron disease with parkinsonism 12 = Neuroleptic-induced parkinsonism 97 = Other neurological disorder(s) (specify) Copyright 2011 University of Rochester. All Rights Reserved. 8/9/11 Page 1 of 2

34 CLINICAL DIAGNOSIS AND MANAGEMENT QUESTIONNAIRE Has there been a change in the clinical diagnosis of this subject since the last visit? (0 = No, 1 = Yes) If Yes (1) to question 4, indicate all factors that have been most infl uential in your current diagnosis: (0 = No, 1 = Yes) 4a. Dopamine transporter imaging information 4b. Clinical signs 4c. Response/lack of response to PD medication 4d. Natural history of condition (i.e. rapid progression, lack of progression) 4e. Other (specify) 4. 4a. 4b. 4c. 4d. 4e. 5. Has there been a change in the clinical management of this subject since the last visit? (0 = No, 1 = Yes) Current management for this subject includes: (0 = No, 1 = Yes) 6a. Management aimed at treating symptoms of PD, including dopamine replacement therapy, anticholinergics, MAO-B inhibitor 6b. Enrolled in a treatment trial for PD 6c. Management aimed at treating a condition other than PD or PS not associated with a dopamine transporter deficit 6d. Additional diagnostic testing 6e. No treatment necessary 6a. 6b. 6c. 6d. 6e. 7. Has the subject seen another neurologist since the last visit? (0 = No, 1 = Yes) 7. 7a. If yes, what is that neurologist s working diagnosis? (specify) Copyright 2011 University of Rochester. All Rights Reserved. 8/9/11 Page 2 of 2

35 MOTOR ASSESSMENTS/ MDS UPDRS

36 USE OF PD MEDICATION INITIALS VISIT DATE 1. Is the subject on medication for treating the symptoms of Parkinson disease? (0 = No, 1 = Yes) If yes, what is the subject taking: (check all that apply) Levodopa Dopamine Agonist Other 3. Was the full MDS-UPDRS assessed at this visit? (0 = No, 1 = Yes) Date of most recent PD medication dosing: Time of most recent PD medication dosing prior to MDS-UPDRS being assessed: (24-hour clock) 5. : 6. Time that the full MDS-UPDRS was administered: (24-hour clock) 6. : NOTE: At month 12 and subsequent annual follow-up visits, subjects taking levodopa or dopamine agonist will have PD medication dosing in clinic, followed by a repeat motor exam one hour after dosing (complete MDS-UPDRS Post Dose). Copyright 2010 Parkinson Study Group. All Rights Reserved. 5/6/10 Page 1 of 1

37 MDS UPDRS & Hoehn & Yahr MDS UPDRS Permissions Permission is required to use the MDS developed Rating Scales (with the exception of personal/individual use). Reproduction, translation, modification, sale, or distribution of any portion of the MDS Rating Scales is strictly prohibited. MDS Rating Scales may not be incorporated into clinical trials, training or certification programs or materials, software programs, or otherwise except through use of the Permissions Request Form and payment of applicable fees.

38 MDS-UPDRS (POST DOSE) INITIALS VISIT DATE A. Time of PD medication dosing in clinic: (24-hour clock) B. Time Part III and Hoehn & Yahr administered: A. : B. : 3.1 Speech 3.10 Gait 3.2 Facial expression 3.11 Freezing of gait 3.3a Rigidity - Neck 3.12 Postural stability 3.3b Rigidity - RUE 3.13 Posture 3.3c Rigidity - LUE 3.14 Global spontaneity of movement 3.3d Rigidity - RLE 3.15a Postural tremor - Right hand 3.3e Rigidity - LLE 3.15b Postural tremor - Left hand 3.4a Finger Tapping Right Hand 3.16a Kinetic tremor - Right hand 3.4b Finger Tapping Left Hand 3.16b Kinetic tremor - Left hand 3.5a Hand movements - Right Hand 3.17a Rest tremor amplitude - RUE 3.5b Hand movements - Left Hand 3.17b Rest tremor amplitude - LUE 3.6a Pronation - Supination Movements - Right Hand 3.17c Rest tremor amplitude - RLE 3.6b Pronation - Supination Movements - Left Hand 3.17d Rest tremor amplitude - LLE 3.7a Toe tapping - Right foot 3.17e Rest tremor amplitude - Lip/jaw 3.7b Toe tapping - Left foot 3.18 Constancy of rest 3.8a Leg agility - Right leg 3.19 Were dyskinesias present No Yes 3.8b Leg agility - Left leg 3.20 Did these movements interfere with ratings No Yes 3.9 Arising from chair 3.21 Hoehn and Yahr Stage Examiner Copyright 2010 University of Rochester. All Rights Reserved. 5/6/10 STAFF CODE Page 1 of 1

39 MODIFIED SCHWAB & ENGLAND ACTIVITIES OF DAILY LIVING INITIALS VISIT DATE 100% Completely independent. Able to do all chores without slowness, diffi culty or impairment. Essentially normal. Unaware of any diffi culty. 90% Completely independent. Able to do all chores with some degree of slowness, diffi culty and impairment. Might take twice as long. Beginning to be aware of diffi culty. 80% Completely independent in most chores. Takes twice as long. Conscious of diffi culty and slowness. 70% Not completely independent. More diffi culty with some chores. Three to four times as long in some. Must spend a large part of the day with chores. 60% Some dependency. Can do most chores, but exceedingly slowly and with much effort. Errors; some impossible. 50% More dependent. Help with half, slower, etc. Diffi culty with everything. 40% Very dependent. Can assist with all chores but few alone. 30% With effort, now and then does a few chores alone or begins alone. Much help needed. 20% Nothing alone. Can be a slight help with some chores. Severe invalid. 10% Totally dependent, helpless. Complete invalid. 0% Vegetative functions such as swallowing, bladder, and bowel functions are not functioning. Bedridden. Consensus rating (Investigator, patient, other sources) 1. Fahn S, Elton RL, Members of the UPDRS Development Committee. The Unifi ed Parkinson s Disease Rating Scale. In Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent developments in Parkinson s disease, vol 2. Florham Park, NJ: Macmillan Health Care Information, 1987: , Examiner (1/25/08) 5/6/10 STAFF CODE Page 1 of 1

40 NON MOTOR ASSESSMENTS

41 HOPKINS VERBAL LEARNING TEST REVISED (HVLT) Hopkins Verbal Learning Test Permissions The Hopkins Verbal Learning Test must be purchased from PAR, Inc. (

42 HOPKINS VERBAL LEARNING TEST - REVISED INITIALS VISIT DATE Record scores below from the HVLT-R Test Booklet. 1. Hopkins Verbal Learning Test - Revised 1.1 Immediate Recall Trial 1 (# correct) 1.2 Immediate Recall Trial 2 (# correct) Immediate Recall Trial 3 (# correct) Delayed Recall Trial 4 (# correct after 20 minutes delay) Delayed recognition - Total # of true - positive responses ( hits ) Delayed recognition - # of related false - positive errors 1.7 Delayed recognition - # of unrelated false - positive errors Adapted and reproduced by special permission of the Publisher, Psychological Assessment Resources, Inc., North Florida Avenue, Lutz, Florida 33549, from the Hopkins Verbal Learning Test-Revised by Jason Brandt, PhD and Ralph H.B. Benedict, PhD, Copyright 1991, 1998, 2001 by PAR, Inc. Further reproduction is prohibited without permission from PAR, Inc. (10/16/07) 5/6/10 Page 1 of 1

43 BENTON JUDGMENT OF LINE ORIENTATION Benton Line Orientation Test Permissions The Benton Judgment of Line Orientation must be purchased from PAR, Inc. (

44 SEMANTIC FLUENCY INITIALS VISIT DATE 1. Record the number of animals named in one minute (60 seconds): Record the number of vegetables named in one minute (60 seconds): Record the number of fruits named in one minute (60 seconds): 3. Goodglass H. Assessment of aphasia and related disorders. Philadelphia: Lea and Febiger, /6/10 Page 1 of 1

45 LETTER NUMBER SEQUENCING Letter Number Sequencing Test Permissions Permissions for use of the Letter Number Sequencing Test as used in the PPMI study must be requested from Pearson Assessments ( )

46 SYMBOL DIGIT MODALITIES TEST Symbol Digit Modalities Test Permissions Permissions for use of the Symbol Digit Modalities Test as used in the PPMI study must be requested from Western Psychological Services WPS (

47 SYMBOL DIGIT MODALITIES TEST INITIALS VISIT DATE 1. Total correct (Response should be 0-110) 1. Material from the copyright 1973, 1976, 1982 by Western Psychological Services. Format adapted by M. Hunter, University of Rochester Medical Center, for specifi c, limited research use under license of the publisher, WPS, Wilshire Boulevard, Los Angeles, California 90025, U.S.A. ( No additional reproduction, in whole or in part, by any medium or for any purpose, may be made without the prior, written authorization of WPS. All rights reserved. 10/22/10 Page 1 of 1

48 1 3 2 PPMI 4 3 INITIALS VISIT DATE

49 Back MONTREAL COGNITIVE ASSESSMENT (MOCA) PPMI INITIALS PPMI VISIT NONO VISIT 4 3 VISIT DATE MM DD YYYY

50 1 3 2 PPMI 4 3 INITIALS VISIT DATE MONTREAL COGNITIVE ASSESSMENT (MOCA) - ITALIA - NOME: Scolarità: Data di nascita: Sesso: DATA: VISUOSPAZIALE / ESECUTIVO Copi Disegni un orologio (undici e dieci) PUNTI Il cubo (3 punti) DENOMINAZIONE [ ] [ ] [ ] [ ] [ ] Contorno Numeri Lancette / 5 [ ] [ ] [ ] / 3 MEMORIA Leggere la lista di parole: il Faccia Velluto Chiesa Margherita Rosso soggetto deve ripeterle. Fare 0 le prime 2 prove di seguito e 1 prova il Richiamo dopo 5 min. punti 2 prova ATTENZIONE Leggere la serie di cifre Il soggetto deve ripeterle [ ] ( una cifra / sec.) Il soggetto deve ripeterle in ordine inverso [ ] / 2 Leggere la serie di lettere. Il soggetto deve dare un colpetto con la mano sul tavolo ad ogni lettera A. 0 punti se 2 errori [ ] F B A C M N A A G H L B A F A H D E A A A G A M O F A A B / 1 Sottrazione di 7 partendo da 100 per 5 volte [ ] 93 [ ] 86 [ ] 79 [ ] 72 [ ] 65 4 o 5 sottrazioni corrette: 3 pt, 2 o 3 corrette: 2 pt, 1 corretta: 1 pt, 0 corretta: 0 pt / 3 LINGUAGGIO Ripeta: So solo che oggi dobbiamo aiutare Giovanni. [ ] Il gatto si nascondeva sempre sotto il divano quando c erano cani nella stanza. [ ] Fluenza / In 1 minuto, nomini il maggior numero possibile di parole che iniziano con la lettera F. [ ] (N 11 parole) / 1 ASTRAZIONE Similitudini tra per es. banana / arancio = frutti; [ ] treno / bicicletta [ ] orologio / righello / 2 RICHIAMO DIFFERITO Opzionale Deve ricordarsi le parole SENZA AIUTO AIUTO Categoria Seman. Scelta multipla Faccia [ ] Velluto [ ] Chiesa [ ] Margherita [ ] Rosso [ ] Punti solo per ripetizione SENZA AIUTO ORIENTAMENTO [ ] Data [ ] Mese [ ] Anno [ ] Giorno [ ] Luogo [ ] Città / 6 / 2 / 5 Z. Nasreddine. Traduzione a cura di A. Pirani, C. Tulipani, M. Neri. Versione 26 Luglio Normale: 26 / 30 TOTALE /30 Aggiungere 1 punto se < 12 anni di istruzione

51 EPWORTH SLEEPINESS SCALE INITIALS VISIT DATE A. Source of Information: 1 = Patient, 2 = Caregiver, 3 = Patient and caregiver A. How likely are you to doze off or fall asleep in situations described below, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you haven t done some of these things recently try to work out how they would have affected you. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze 1 = slight chance of dozing 2 = moderate chance of dozing 3 = high chance of dozing It is important that you answer each question as best you can. 1. Sitting and reading 2. Watching TV Sitting, inactive in a public place (e.g., a theatre or a meeting) As a passenger in a car for an hour without a break Lying down to rest in the afternoon when circumstances permit Sitting and talking to someone Sitting quietly after a lunch without alcohol In a car, while stopped for a few minutes in the traffi c 8. M. W. Johns /6/10 Page 1 of 1