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PPMI Study CRF and Benton Judgment of Line Orientation. XX X X X XX. Semantic Fluency 38. XX X X X XX. Letter Number Sequencing (PD) 40. XX X X X XX. Symbol Digit Modalities Test 42

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  • PPMI 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: http://www.ppmi-info.org/contact-us/

    06-FEB-2012

  • PPMI 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 collection)

    76 Biospecimen

    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

  • 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

  • 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 Visit Description Months (+30 days) -1 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 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 Xd General Physical Exam 24 X Vital Signs 26 X Xc X X X Xc X Xc X Xc X Xc X Xc Xc 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 Xd 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 Xe X Xe X Xe X Xe X Xe X Xe X Xe Xe Xe Clinical Labs 59 X X Xi X X X X X Xd 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 Xg X X X X X X Xh 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 Xa Xa Xa Xa Xa Xa Xa Xa Xa Xa 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

    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. ST = Symptomatic Therapy c Height and weight also collected. PW = Premature Withdrawal d Conduct as clinically indicated - see protocol Unscheduled Visit. e Biomic urine sample also collected. 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.

    FNL= Final

    If needed

    PPMI Schedule of Activities PARKINSON DISEASE (PD) SUBJECTS

    Unsched. Visit

    Level # PW STFNL

  • 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 Visit Description Months (+30 days) -1 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 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 Xd General Physical Exam 24 X Vital Signs 26 X Xc X X X Xc X Xc X Xc X Xc X Xc Xc X Pregnancy Form 28 X MDS-UPDRS/Hoehn & Yahr X X X X X X X Xd 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 Xe X Xe X Xe X Xe X Xe X Xe X Xe Xe Clinical Labs 59 X X Xh X X X X X Xd 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 Xg

    DaTSCAN Imagingb 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 Xa Xa Xa Xa Xa Xa Xa Xa Xa 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

    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. 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. 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.

    FNL= Final PW = Premature Withdrawal

    Unsched. Visit

    If needed

    PPMI Schedule of Activities HEALTHY CONTROL (HC) SUBJECTS

    Level # PWFNL

  • Visit Number ReSC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07 Visit Description Months (+30 days) -1 0 3 6 9 12 15 18 21 24 Confidential Subject Identification Log X Written Informed Consent X Screening/Demographics 02 X Inclusion/Exclusion - SWEDD 86 X X (rev