Control Baseline Visit (BL)
Contents
1. Ca Date of most recent PD medication dosing EN M LE Cb Time of most recent PD medication dosing 24 hour clock Cb EN EN 1 Lumbar puncture for collection of CSF 1 0 Not Done 1 Collected 2 Partial Collection 3 Attempted no collection If response is O 2 or 3 specify in comments Indicate needle used to collect CSF 3 1 20g Quincke sharp bevelled needle 2 22g Quincke sharp bevelled needle 3 25g Quincke sharp bevelled needle 4 22g Sprotte atraumatic needle 5 24g Sprotte atraumatic needle preferred 6 18g Copyright 2010 University of Rochester All Rights Reserved 6 13 12 Page 1 of 3 4 PPMI LUMBAR PUNCTURE l e 4 Indicate method of collecting the CSF 4 1 Gravity 2 Syringe suction Lumbar puncture performed at the 5 17 0 L2 L3 Interspace 1 L3 L4 Interspace 2 14 15 Interspace 3 Unknown Subject position when lumbar puncture performed 6 1 Sitting leaned over preferred 2 Lying curled up on side 3 Unknown Time CSF collection completed 24 hour clock 7 EN EN Volume of CSF collected prior spinning milliliters 8 EN Time CSF was centrifuged 24 hour clock 9 EN EN Within 15 minutes from sample collection Rate of centrifugation for the CSF sample xg 10 Temperature at which CSF tube was spun Celsius 14 EN Time CSF sample aliquotted 24 hour clock 12 EN EN Total volume of C2. heir 1 2 3 4 40 I get in a state of tension or turmoil as I think over my recent concerns and interests 1 2 3 4 1968 1977 Charles D Spielberger All Rights Reserved Published by Mind Garden Inc www mindgarden com PPMI S 0 page 1 of2 MM DD YYYY Questionnaire for Impulsive Compulsive Disorders in Parkinson s Disease QUIP Current Short Reported z Patient Informant Patient and Informant Patient name Date f information reported by an informant answer questions based on your understanding of the patient Answer ALL QUESTIONS based on CURRENT BEHAVIORS LASTING AT LEAST 4 WEEKS A GAMBLING 1 Do you or others think you have an issue with too much gambling behaviors such as casinos internet gambling lotteries scratch tickets betting or slot or poker machines Yes No 2 Do you have difficulty controlling your gambling behaviors such as increasing them over time or having trouble cutting down or stopping them Yes No B SEX 1 Do you or others think you have an issue with too much sex behaviors such as making sexual demands on others promiscuity prostitution change in sexual orientation masturbation internet or telephone sexual activities or pornography Yes No 2 Do you think too much about sex behaviors such as having trouble keeping thoughts out of your mind or feeling guilty Yes No C BUYING 1 Do you or others think you have an issue with too much buyin
3. Notice that the boxes on the top have symbols but the boxes beneath are empty You are to fill in each empty box with the number that goes with each symbol according to the way they are paired at the top of the page For example if you look at the first symbol point to the first symbol in the row beneath the key and then look up at the key you see that this symbol is paired with the number 4 show the pairing So you would write a 4 in this box write a 4 in the first box This next symbol point to the next symbol is paired with 6 so you would put a 6 in this box write 6 in the second box Now what number goes in this box point to third box These instructions may differ depending on the version of the form being used Subject should say nine If not correct the subject and explain the error When the subject appears to comprehend the task say Good Now for practice fill in the boxes up to this double line and then stop Correct immediately any errors made during the practice period explaining the subject s error Repeat the instructions and review the correct coding of the practice boxes as necessary until the subject understands the task Continue with the test by saying When I say Go write in the numbers just like you have been doing as fast as you can until I say Stop Work as quickly as you can moving from one line to the next without skipping any boxes If you
4. Subject has not reported taking any concomitant medications log is blank Status of Adverse Event Log 1 Updated log at this visit 2 No data updates to 22 log log is not blank 3 Subject has not reported any events log is blank Copyright 2002 University of Rochester All Rights Reserved 10 16 09 7 25 12 Page 1 of 2 PPMI SIGNATURE FORM 2 10 Reviewed Current Medical Conditions Log information and made any necessary 2410 j changes to the Current Medical Conditions Log 1 Updated log at this visit 2 No data updates to log log is not blank 3 Subject has not reported any medical conditions log is blank 3 Comments have reviewed the data entries for this visit and determined that they are complete accurate and consistent with source documents if available All entries were made by me or by a person who is under my supervision Po INVESTIGATOR S SIGNATURE STAFF CODE Copyright 2002 University of Rochester All Rights Reserved 10 16 09 7 25 12 Page 2 of 2
5. correct after 20 minutes delay 1 4 EN 1 5 Delayed recognition Total amp of true positive responses hits 1 5 BN 1 6 Delayed recognition of related false positive errors 1 6 17 Delayed recognition of unrelated false positive errors 1 7 2 Indicate the HVLT R test booklet used at this visit if different than indicated in the protocol comment below Form 1 Form 2 Form 3 Form 4 Form 5 Form 6 Comment Adapted and reproduced by special permission of the Publisher Psychological Assessment Resources Inc 16204 North Florida 1 0 1 6 07 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 4 23 12 PPMI LINE ORIENTATION REFER TO BENTON JUDGMENT OF LINE ORIENTATION FORM RECORD SHEET COMPLETE ONLY THE ODD TEST ITEMS AT BASELINE MONTH 24 V06 MONTH 48 V 10 LINE ORIENTATION NOTES CHECK OPERATIONS MANUAL AS NECESSARY Booklet in front of subject opened so that stimulus items in upper half are at an angle of about 45 Subject is allowed to position booklet to their best advantage within reason Explaining the task as necessary during the Practice Items is critical PRACTICE ITEM A Which two numbered lines point to numbered lines are in exactly the same position an
6. LABORATORY PROCEDURES 15 8 YYYY 1 Date of last intake of food oo m 1a Time of last intake of food 24 hour clock 1a EN EN 1b Fasting status 1b 1 Fasted minimum of 8 hours 2 Low Fat Diet 3 Not Fasted No Low Fat Diet 2 Is subject on medication for PD 0 No 1 Yes 2 2 Date of most recent PD medication e dosing YYYY 2b Time of most recent PD medication dosing 24 hour clock 2b EN EN Urine Sample Collection 3 Urine for storage and analysis 0 Not collected 1 Collected 3 3a Date of urine sample collection 3a EN EN MM DD YYYY 3b Time of urine sample collection 24 hour clock 3b EN EN 3c Time of centrifugation 24 hour clock 3c EN EN 3d Rate of centrifugation xg 3d PERE 3e Duration of centrifugation minutes 3e EN 3f Indicate temperature at which tube was spun Celsius 3f EN 3g Time urine sample placed in freezer 24 hour clock 3g EN Copyright 2010 University of Rochester All Rights Reserved 6 13 12 Page 1 of 3 PPMI LABORATORY PROCEDURES Blood Sample Collection 4 Date blood samples collected RNA PAXgene RED TOP 5 Blood for PAXgene RNA 0 Not collected 1 Collected 5b 5 5d Time of PAXgene RNA sample collection 24 hours at room temperature 5 8 s aC Date PAXgene RNA samples placed in 5b EN EN MM DD freez
7. no yes blood pressure NH no yes d other symptoms not symptoms related yes to Parkinson s disease This questionnaire is made available free of charge with the permission of the authors to all those undertaking non profit and profit making research Future users may be requested to share data for psychometric purposes Use of this questionnaire in studies should be communicated to the developers No changes may be made to the questionnaire without written permission Please use the following reference in publications Visser M Marinus J Stiggelbout AM van Hilten JJ Assessment of autonomic dysfunction in Parkinson s disease The SCOPA AUT Mov Disord 2004 19 1306 12 For further information please contact M Visser Leiden University Medical Center Department of Neurology K5Q P O Box 9600 NL 2300 RC Leiden email m visser lumc nl PPMI COGNITIVE CATEGORIZATION MM DD YYYY A Indicate the source of information A 1 Subject 2 Caregiver 3 Subject and Caregiver Determining Report of Cognitive Decline Based on information provided by the subject the informant and or based on the Site Investigator s judgment determine whether the subject has experienced a decline in cognition compared with pre morbid abilities i e pre PD The following cognitive abilities should be considered Attention Ability to sustain and direct attention lapses Memory Registration recall of
8. 1 2 Watching TV 2 Sitting inactive in a public place e g a theatre or a meeting 3 4 As a passenger in a car for an hour without a break 4 b Lying down to rest in the afternoon when circumstances permit 5 6 Sitting and talking to someone 6 7 Sitting quietly after a lunch without alcohol 7 8 In a car while stopped for a few minutes in the traffic 8 M W Johns 1990 1997 5 6 10 Page 1 of 1 PPMI REM SLEEP DISORDER QUESTIONNAIRE aje MM DD YYYY A Source of Information 1 Patient 2 Caregiver 3 Patient and caregiver A 1 sometimes have very vivid dreams 0 No 1 Yes 1 2 My dreams frequently have an aggressive or action packed content 2 0 No 1 Yes The dream contents mostly match my nocturnal behaviour 0 No 1 Yes g E 4 know that my arms or legs move when sleep 0 No 1 Yes 4 j 5 It thereby happened that almost hurt my bed partner or myself 0 No 1 Yes 5 6 have or had the following phenomena during my dreams 6 1 speaking shouting swearing laughing loudly 0 No 1 Yes 6 1 EN 6 2 sudden limb movements fights 0 No 1 Yes 6 2 6 3 gestures complex movements that are useless during sleep e g to wave 6 3 to salute to frighten mosquitoes falls off the bed 0 No 1 Yes 6 4 things that fell down around the bed e g bedside lamp book glasses 6 4 0 No 1 Yes I
9. ME EN MN 1 2 3 6 Lfeel upset a u iip SESS deii php dese 1 2 3 7 I am presently worrying over possible misfortunes serene 1 2 3 Os TEST SAti STIS 1 2 3 9 TL feelfrightened ett reete Pt HEN EU be Re EH ERA 1 2 3 10 L feel comfortable inr sa eats wo yates e eee e n Ye ES e ESSERE de 1 2 3 TT Efeel selt confident 1 2 3 IPAE Nervous EE 1 2 3 o needed eti te e deret toe teet tede 1 2 3 14 T feel ie ip em p ds 1 2 3 15 Larnirelaxed sen RERO ERR Qs 1 2 3 16 TieeltOntent tee shania oet ed Pee 1 2 3 TT Lartiwotried ie P LI Or LAS 1 2 3 I8 L feel contused i e RORIS ERU Re E ERE C 1 2 3 19 Lfeel steady s p erect eer pH ER EIER oe PRU seg PESE 1 2 3 20 feel pleasant tte eee tee ete Ep eee eee te erede 1 2 3 1968 1977 Charles D Spielberger All Rights Reserved Published by Mind Garden Inc www mindgarden com SELF EVALUATION QUESTIONNAIRE STAI Form Y 2 Name Date Y d DIRECTIONS UA A number of statements which people have used to describe 4 6 0 gt 4 A themselves are given below Read each statement and then circle the b D d appropriate number to the right of the statement to indicate how you o v qe p generally feel 2T I feel pleasant ene n
10. new things 10 Do you feel you have more problems with memory than most 11 Do you think it is wonderful to be alive now 12 Do you feel pretty worthless the way you now 13 Do you feel full of energy 14 Do you feel that your situation is hopeless 15 Do you think that most people are better off than you are Sheikh JI Yesavage JA Geriatric Depression Scale GDS Recent evidence and 10 16 07 5 6 10 development of a shorter version Clinical Gerontology A Guide to Assessment and Intervention 165 173 NY The Haworth Press 1986 e VISIT NO EBEN LIT IJ YYYY Page 1 of 1 SELF EVALUATION QUESTIONNAIRE STAI Form Y 1 Please provide the following information Name Date S ___ Age Gender Circle M DIRECTIONS o Ly A number of statements which people have Hiero describe themselves are given below t Read each statement and then circle the appropriate number to the right of the statement ty 2 to indicate how you feel right now that is at this moment There are no right or wrong Qy answers Do not spend too much time on any one statement but give the answer which v seems to describe your present feelings best Vy Pt CERE EUH ER 1 2 3 2 L feel secure E E RN 1 2 3 E 1 2 3 4 Efeelstramed aite ee ener nte tete reete ett ede Ue Pee eee cete te eese 1 2 3 IEEE CM
11. recent events or important dates new learning ability misplacement of items forgetting items Orientation Forgetting appointments estimating time spatial or geographical orientation Executive abilities Reasoning ability making decisions following instructions difficulty with calculations Praxis Constructional or mechanical cognitive ability such as use of tools and appliances Language Word finding problems problems with naming or comprehension 1 Has the subject experienced cognitive decline 0 No 1 Yes 1 Determining Functional Impairment Based on information provided by the subject the informant and or based on the Site Investigator s judgment determine whether the subject has experienced a significant decline in functional abilities from a cognitive standpoint to the extent of demonstrating impairment in performing instrumental activities of daily living examples of which include driving managing finances managing medications shopping food preparation participation in hobbies and employment 2 Does the subject have clinically significant functional impairment as a result of 2 cognitive impairment 0 No 1 Yes Copyright O 2012 University of Rochester All Rights Reserved 4 23 12 Page 1 of 2 PPMI COGNITIVE CATEGORIZATION Determining Cognitive Diagnosis Based on your impression of the subject s current cognitive function which may include performance on neuropsychological t
12. 14 1 3 Visit Completion Status Include comment for any answer other than 1 or 7 under 14 question 3 Comments 1 Within visit window and conducted by investigator or coordinator if telephone contact 2 Within visit window and not conducted by investigator 3 Not done If visit not done enter the target visit date in the header 4 Out of visit window and conducted by investigator or coordinator if telephone contact 5 Out of visit window and not conducted by investigator 6 Unscheduled Visit 7 Other specify Indicate why the subject missed the visit 1 2 EN Scheduling issue with the subject Scheduling issue with the staff Family social issues with the subject Subject did not return phone calls to schedule study visit Travel Distance Medical Problems Military Duty Financial Issues Lost to Follow up complete Conclusion of Study Participation form Other Institutionalized ooo dococasom 13 Replaced by Symptomatic Therapy Visit Were all assessments for this visit completed 0 No 1 Yes 1 3 If No 0 please note assessments not completed in question 3 Comments In addition to the assessments covered by the CRFs specific to this visit the following tasks were completed at this visit when applicable 2 1 2 2 Status of Concomitant Medication Log 1 Updated log at this visit 2 No data 24 updates to log log is not blank 3
13. PARKINSON S PROGRESSION MARKERS INITIATIVE PPMI Source Worksheets Baseline Visit PPMI VITAL SIGNS 2 6 MM DD YYYY 1 Weight in Kilograms Baseline and Annual only 1 2 Height in Centimeters Baseline and Annual only 2 EMEN 3 Temperature in Celsius 3 EN 4 Arm used to measure blood pressure 1 Right arm 2 Left arm 4 5 Supine blood pressure systolic diastolic mmHg 5 IL TM LI I to be taken after subject has been supine for 1 3 minutes 6 Supine heart rate beats per minute 6 EBEN to be taken after subject has been supine for 1 3 minutes 9 Standing blood pressure systolic diastolic mmHg 9 TTT YL to be taken after subject has been standing for 1 3 minutes 10 Standing heart rate beats per minute 10 EMEN to be taken after subject has been standing for 1 3 minutes 11 Comments Copyright 2004 University of Rochester All Rights Reserved 10 17 07 5 6 10 Page 1 of 1 PPMI MDS UPDRS REFER TO MDS UPDRS PACKET AND SCORE SHEET TO CONDUCT THE FULL MDS UPDRS AND HOEHN amp YAHR MM DD PPMI HOPKINS VERBAL LEARNING TEST REVISED Record scores below from the HVLT R Test Booklet VISIT NO 6 EHN EARE YYYY 1 Hopkins Verbal Learning Test Revised 1 1 Immediate Recall Trial 1 correct 1 1 EN 1 2 Immediate Recall Trial 2 correct 1 2 EN 13 Immediate Recall Trial 3 correct 1 3 EN 1 4 Delayed Recall Trial 4
14. SF aliquotted after spinning milliliters 13 EN Total number of aliquot tubes 14 TE Was part of sample discarded due to a bloody tap 0 No 1 Yes 15 Time samples were either placed in freezer or placed on dry ice 16 24 hour clock 16a Storage temperature if placed in freezer Celsius 16a Was part of the sample sent to local lab for analyses 0 No 1 Yes 17 If No specify in Comments Copyright 2010 University of Rochester All Rights Reserved 6 13 12 Page 2 of 3 PPMI LUMBAR PUNCTURE 16 4 18 What is the white blood cell count 18 Hare 18b Indicate units Per cubic millimeter Per microliter _ Per liter Other 19 What is the red blood cell count 19 19b Indicate units Per cubic millimeter Per microliter _ Per liter j Other 20 Whatis the total protein 20 EN 20a Indicate units mg dL g dL C g L 21 What is the total glucose 24 EET ENSE 21a Indicate units C mg dL C mmol L 22 Wasa fluoroscopy performed 0 No 1 Yes 22 MM DD YYYY 23 Was a lumbar spine film performed 0 No 1 Yes 23 MM DD YYYY Comments Copyright 2010 University of Rochester All Rights Reserved 6 13 12 Page 3 of 3 PPMI SIGNATURE FORM MM DD YYYY NOTE a signature form is required for each expected study visit and telephone contact whether or not the visit or call was actually performed
15. cessary BUT DO NOT CROSS OVER THE LINE FROM CLARIFICATION TO TRAINING THEM TO DO BETTER GO BACK TO THE PRACTICE ITEMS TO REINSTRUCT THE SUBJECT RATHER THAN USING ACTUAL TEST ITEMS NOTE THE INTERVENTION ON THE CRF The reason for this exception to the rule is that when a spatially competent subject loses set on this test they will obtain a misleading very low score especially since both responses per item must be correct to obtain credit v 05 05 10 PPMI SEMANTIC FLUENCY INSTRUCTIONS SAY I am going to give you a category and I want you to name as fast as you can all of the things that belong in that category For example if I say articles of clothing you could say shirt tie or hat Can you think of other articles of clothing Allow up to 20 seconds for the subject to produce two responses If they cannot clarify the task as best you can and then proceed with the actual testing Animals Vegetables Fruits Time limit 60 seconds per trial Response recording Try to capture verbatim but if you can t keep up with at least the first syllable of a response use a check mark until you can e Written recording helps you catch repetitions and incorrect responses It also allows others to review your scoring Consider audio taping with appropriate consent Scoring The scoring is liberal and follows ADNI Productivity is favored over semantic exactness Animals score total number of correc
16. copyright 1973 1976 1982 by Western Psychological Services Format adapted by M Hunter University 4 23 12 Page 1 of 1 of Rochester Medical Center for specific limited research use under license of the publisher WPS 12031 Wilshire Boulevard Los Angeles California 90025 U S A www wpspublish com 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 REMINDER HOPKINS VERBAL LEARNING TEST DELAYED RECALL TRIAL TRIAL 4 SHOULD BE DONE NOW After Symbol Digit Before the Hopkins Recognition Trial v 04 28 10 REMINDER THE HOPKINS VERBAL LEARNING RECOGNITION TRIAL SHOULD BE DONE NOW After Hopkins Delayed Recall Trial 4 v 05 26 10 PPMI EPWORTH SLEEPINESS SCALE MM DD YYYY 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
17. d point in the same direction as the two lines up here e If subject supplies correct responses say That s right and proceed to Practice Item B then C and so Administer all Practice Items A through E When a subject fails to give a correct response for both lines e g 1 amp 6 for Practice Item A follow the extended instructions given in the Operations Manual e If subject tends to misstate the numbers but points to the correct responses say instead Show me these lines down here Point to them e I f subject does not understand the task and or does not supply a correct response for any of the practice items ollow the Extended Instructions provided in the Operations Manual STARTING THE TEST Open booklet at page labeled Test Items Say Now we are going to do more of these except now the lines which you see up here point to the upper page will be shorter because part of the line has been erased Tell me Show me which two lines down here are pointing in the same direction as the lines up here e Provide encouragement but not right wrong feedback e Be careful to avoid giving non verbal cues regarding response accuracy o E g hesitancy before moving on Behave in exactly the same way regardless of whether the responses are right or wrong e response within 30 seconds encourage subject to make their best guess However there is no time limit for responding The subject s actual responses sh
18. driving with no intended goal or specific purpose Yes No MEDICATION USE 1 Do you or others including your physicians think that you consistently take too much of your Parkinson s medications Yes No Not Applicable 2 Do you have difficulty controlling your use of Parkinson s medications such as experiencing a strong desire for more medication or having worse mood or feeling unmotivated at a lower dosage Yes No Not Applicable QUIP CURRENT SHORT 2 Version 1 0 12 01 08 Modified with permission 02 02 11 Copyright University of Pennsylvania 2008 SOMPA j PPMI Page 1 of 5 MM DD YYYY A Source of Information 1 Patient 2 Caregiver 3 Patient and caregiver A SCOPA AUT By means of this questionnaire we would like to find out to what extent in the past month you have had problems with various bodily functions such as difficulty passing urine or excessive sweating Answer the questions by placing a cross in the box which best reflects your situation If you wish to change an answer fill in the wrong box and place a cross in the correct one If you have used medication in the past month in relation to one or more of the problems mentioned then the question refers to how you were while taking this medication You can note the use of medication on the last page 1 In the past month have you had difficulty swallowing or have you choked never sometimes regularly often In the past month has sali
19. e instruction that the numbers be recited first e Allow the subject to make self corrections if they recognize that they are making an error but do not cue or prompt them to do so Aclarification of the instructions may be offered if the subject requests it during the testing e Do not repeat a letter number sequence once you have read it to the subject If the subject asks that you repeat a trial saying they didn t catch it or similar say you can t give them the opportunity to attempt a response then say lets try another one and go to the next trial v 05 05 10 PPMI LETTER NUMBER SEQUENCING PD aJo MM DD YYYY Instructions All responses should be recorded verbatim in the Subject Response section below Score 1 for each correct response and 0 for each incorrect response Discontinue Rule After scores of 0 for all 3 trials of an item Item Trial Correct Response Subject Response Score 0 or 1 1a L 2 2 L 1b 6 6 w 1c 5 5 te 2a F 7 L 7 F L 2b R 4 D 4 D R 2 2c H 1 8 1 8 H 2 T 9 A 3 3 9 A T sa 3b V 1 J 5 1 5 J V 3 3c 7 N 4 L 4 7 L N 4a 8 D 6 G 1 1 6 8 D G 4 4b K 2 C 7 S 2 7 C K S a 4c 5 P 3 Y 9 3 5 9 P Y 4 WHET Copa E NCE Pen ne NS WORTEN 71808 SIO age To 2 All rights reserved Wechsler Memory Scale WMS are trademarks the US and or other countr
20. e aware that sexuality is a highly intimate subject we would still like you to answer these questions For the questions on sexual activity consider every form of sexual contact with a partner or masturbation self gratification An extra response option has been added to these questions Here you can indicate that the situation described has not been applicable to you in the past month for example because you have not been sexually active Questions 22 and 23 are intended specifically for men 24 and 25 for women The following 3 questions are only for men 22 In the past month have you been impotent unable to have or maintain an erection never sometimes regularly often not applicable 23 In the past month how often have you been unable to ejaculate never sometimes regularly often not applicable 23a In the past month have you taken medication for an erection disorder If so which medication no yes Proceed with question 26 The following 2 questions are only for women 24 In the past month was your vagina too dry during sexual activity never sometimes regularly often not applicable 25 In the past month have you had difficulty reaching an orgasm never sometimes regularly often not applicable SOMPA j PPMI Page 5 of 5 The following questions are for everyone 26 Inthe past month have you used medication for a constipation no yes b urinary problems
21. er Time PAXgene RNA samples placed in freezer Storage temperature Celsius PLASMA EDTA PURPLE TOP 6 Blood for plasma 0 Not collected 1 Collected 6a Time of plasma sample collection 24 hour clock 6b Time of centrifugation 24 hour clock 6c Rate of centrifugation xg 6d Duration of centrifugation minutes 6e Indicate temperature at which tube was spun Celsius 6f Total volume aliquotted after spinning milliliters 6g Total number of aliquot tubes 6h Time plasma samples placed in freezer 24 hour clock 6i Storage temperature Celsius Copyright 2010 University of Rochester All Rights Reserved 6 13 12 s T ET 5d 4 Oo 2 o B O Q HE D xd ain e F Page 2 of 3 PPMI LABORATORY PROCEDURES SERUM RED TOP 7 Blood for serum 0 Not collected 1 Collected 7a Time of serum sample collection 24 hour clock 7b Time of centrifugation 24 hour clock of centrifugation xg Duration of centrifugation minutes 7e Indicate temperature at which tube was spun Celsius 7f Total volume aliquotted after spinning milliliters 7g Total number of aliquot tubes 7h Time serum samples placed in freezer 24 hour clock 7i Storage temperature Celsius Comments Copyright 2010 University of Rochester All Rights Reserved 6 13 12 Page 3 of 3 PPMI WHOLE BLOOD SAMPLE E
22. esting as well as your knowledge of his her pre morbid cognitive function and the degree to which cognitive deficits impact his her ability to carry out daily activities please rate the subject s current cognitive status The determination of dementia implies 1 cognitive function that is impaired in more than one cognitive domain 2 decline from pre morbid function and 3 significant impact of cognitive impairment on daily function The determination of MCI is based on 1 impairment in at least one cognitive domain 2 decline from pre morbid function and 3 lack of significant impact of cognitive impairment on daily function 3 Based on your clinical impression which of the following categories best describes 3 the subject s cognitive state 1 Normal Cognition PD NC 2 Mild Cognitive Impairment PD MCI 3 Dementia PDD 4 What is your level of confidence of this cognitive diagnosis 4 1 2 90 100 2 50 89 3 10 49 4 2 0 9 5 Did you review any neuropsychological tests including MoCA scores in making this 5 determination 0 No 1 Yes Copyright 2012 University of Rochester All Rights Reserved 4 23 12 Page 2 of 2 PPMI UNIVERSITY OF PENNSYLVANIA SMELL ID TEST MM DD YYYY Record score from each booklet 1 Score from booklet 1 1 2 Score from booklet 2 2 Score from booklet 3 3 4 Score from booklet 4 4 Comments 5 6 10 Page 1 of 1 PPMI
23. ever sometimes regularly often use catheter 13 In the past month have you had to pass urine at night o never sometimes regularly often use catheter PPMI Page 3 of 5 14 15 16 17 18 19 20 21 In the past month when standing up have you had the feeling of either becoming light headed or no longer being able to see properly or no longer being able to think clearly _ sometimes regularly often In the past month did you become light headed after standing for some time _ sometimes regularly often lt a Have you fainted in the past 6 months sometimes regularly often i C lt e 4 In the past month have you ever perspired excessively during the day E E E sometimes regularly often 2 19 lt H In the past month have you ever perspired excessively during the night sometimes regularly often i C lt e 4 In the past month have your eyes ever been over sensitive to bright light _ sometimes regularly often i oO lt e 4 In the past month how often have you had trouble tolerating cold E E sometimes regularly often 2 0 lt H In the past month how often have you had trouble tolerating heat L sometimes regularly often SOMPA j PPMI Page 4 of 5 The following questions are about sexuality Although we ar
24. g behaviors such as too much of the same thing or things that you don t need or use Yes No 2 Do you engage in activities specifically to continue the buying behaviors such as hiding what you re doing lying hoarding things borrowing from others accumulating debt stealing or being involved in illegal acts Yes _ No D EATING 1 Do you or others think you have an issue with too much eating behaviors such as eating larger amounts or different types of food than in the past more rapidly than normal until feeling uncomfortably full or when not hungry Yes No 2 Do you have urges or desires for eating behaviors that you feel are excessive or cause you distress including becoming restless or irritable when unable to participate in the behavior Yes No QUIP CURRENT SHORT 1 Version 1 0 12 01 08 Modified with permission 02 02 11 Copyright University of Pennsylvania 2008 PPMI S 0 Page2ote Questionnaire for Impulsive Compulsive Disorders in Parkinson s Disease QUIP Current Short E OTHER BEHAVIORS Do you or others think that you spend too much time 1 On specific tasks hobbies or other organized activities such as writing painting gardening repairing or dismantling things collecting computer use working on projects etc Yes No 2 Repeating certain simple motor activities such as cleaning tidying handling examining sorting ordering or arranging objects etc Yes No 3 Walking or
25. ies of Pearson Education Inc or its affiliate s PPMI LETTER NUMBER SEQUENCING PD a o Instructions All responses should be recorded verbatim in the Subject Response section below Score 1 for each correct response and 0 for each incorrect response Discontinue Rule After scores of for all 3 trials of an item Item Trial Correct Response Subject Response Score 0 or 1 5a M 4 E 7 Q 2 2 4 7 E M Q sa bb W 8 H 5 F 3 3 5 8 F H W s 5c 6 G 9 A 2 S 2 6 9 A G S sc R 3 B 4 Z 1 C 1 3 4 B C R Z sa 6b BS T 0 J42 X 7 2 5 7 9 J T X e 6c E 1 H 8 R 4 D 1 4 8 D E H R 6 7a 5 H 9 S 2 N 6 A 2 5 6 9 A H N S e 7b D 1 R 9 B 4 K 3 1 3 4 9 B D K R w 7 7 M 2 T 6 F 1 Z 1 2 6 7 F M T Z Wechsler Memory Scale Third Edition WMS III Copyright 1997 NCS Pearson Inc Reproduced with permission 3 16 09 5 6 10 Page 2 of 2 All rights reserved Wechsler Memory Scale and WMS are trademarks the US and or other countries of Pearson Education Inc or its affiliate s PPMI SYMBOL DIGIT MODALIITES TEST INSTRUCTIONS FORM 1 NOTE TO WAIS III IV USERS TIME LIMIT IS 90 SECONDS Administration Place the test form on the table in front of the subject and say Look at the boxes at the top of the page Each box in the upper row has a symbol in it and each box below it has a number Now look at the next line of boxes point to the first line of boxes without numbers
26. l for full instructions 1 16 31 2 17 32 3 18 33 4 19 34 5 20 35 6 21 36 7 22 37 8 23 38 9 24 39 10 25 40 11 26 41 12 27 42 13 28 43 14 29 44 15 30 45 04 27 10 PPMI SEMANTIC FLUENCY FRUITS Site Number Subject Number Visit Date NAME AS MANY FRUITS AS YOU CAN IN 60 SECONDS Examiners Write responses verbatim whenever possible substitute checkmark only when you cannot keep up Do not count repetitions One prompt allowed if no response for 15 seconds or patient states they cannot think of any more Please tell me all the fruits you can think of See Operations Manual for full instructions 1 16 31 2 17 32 3 18 33 4 19 34 5 20 35 6 21 36 7 22 37 8 23 38 9 24 39 10 25 40 11 26 41 12 27 42 13 28 43 14 29 44 15 30 45 04 27 10 PPMI SEMANTIC FLUENCY MM DD YYYY 1 Record the number of animals named in one minute 60 seconds 1 EN 2 Record the number of vegetables named in one minute 60 seconds 2 EN 3 Record the number of fruits named in one minute 60 seconds 3 BE Goodglass H Assessment of aphasia and related disorders Philadelphia Lea and Febiger 5 6 10 Page 1 of 1 1972 PPMI LETTER NUMBER SEQUENCING INSTRUCTIONS Definitions An example of a trial is la An example of an item 1 through Ic Each item is composed of 3
27. make a mistake cross it out and write the correct answer below Remember to work as quickly as you can Ready Go Start timing Do not allow the subject to skip any boxes At the end of 90 seconds say STOP Be sure that the subject does not continue working after the time limit is reached The score is the number of correct responses in 90 seconds Do not include the practice items or incorrect responses in the total score Score range 0 110 v 08 19 10 SUBJECT ID KEY FORMI for www wpspublish com No of WPS All rights ty of Rochester Medical Cent Universi o ochester Medica enter Californ ia 90025 U S A gt gt TOTAL CORRECT Format adapted by M Hunter WPS 12031 Wilshire Eun Psychological Services E S a Sod Sod Q ps 0 S wp N co o ao c 0 o Cod Od E 0 ie Oo n0 D aa 9 Mod gt Q n o0 9 o a DD E E d Sod H do d od a authorization written any purpose for in part by any medium or PPMI SYMBOL DIGIT MODALITIES TEST MM DD YYYY 1 Total correct Response should be 0 110 1 EMEN 2 Indicate the form used at this visit if different than indicated in the protocol comment below Form 1 Form 2 Comment Material from the
28. nt ere tetti te lees et ee t de e Bem teet ets 1 2 3 4 22 T Teel nervous and restless iret et t cete tee UR Dee eed tete credet 1 2 3 4 23 pfeel satishiedwithi myself ede Eee reete costes let edet 1 2 3 4 24 I wish I could be as happy as others seem to be 0 ee eee ceseceseceseeeseeeeneeeneeeaeesaeeenaeenaees 1 2 3 4 25 feel like a enne c Re e o ee d re M 1 2 3 4 20 L Teelrested issue ette e e aa eto ERI ERE 1 2 3 4 27 Iam calm cool and collected iiti eek tete ak Hase b he MEE REM EA ER MERE R ERR RE 1 2 3 4 28 I feel that difficulties are piling up so that I cannot overcome them 1 2 3 4 29 I worry too much over something that really doesn t matter eese 1 2 3 4 30 Tam happy E 1 2 3 4 Lhave disturbing thoughts ee reete rper ted 1 2 3 4 32 Llack self confidence ss nudae b RE REED ee Lg ede 1 2 3 4 33 Lteel Secure e COS que a det 1 2 3 4 34 Emake decisions easily ree e teet e dettes 1 2 3 4 35 Theol madequate sis eee eri e lel ot ee eme eiue i ee et uertit 1 2 3 4 30 Dam contents une Rhen e ree ier ee eee ee ee 1 2 3 4 37 Some unimportant thought runs through my mind and bothers 1 2 3 4 38 I take disappointments so keenly that I can t put them out of my mind 1 2 3 4 30 Lama steady DeESOD neto
29. ould be entered on the Record Form not just right or wrong Spontaneous corrections by the subject are accepted Both responses must be correct for the item to be scored as correct The correct responses are printed on the work sheet Place a check next to correct items Data entry is item by item rather than by total correct Complete all 15 Test Items Score range 0 15 There is one exception to this rule THIS INTERVENTION SHOULD OCCUR VERY RARELY Occasionally a subject will demonstrate reasonable spatial orientation e g on the practice items or on earlier items but then appears to forget what it is that the test requires Evidence for this would be responses that are not at all close to being correct or an indication that the subject is behaving in a highly distracted manner e g giving an answer that suggests that they are giving two responses for one of the stimuli and ignoring the other or giving two responses from the same hemispace when the two stimuli lines are clearly on opposite sides of the page If this occurs AND appears to represent a gross misunderstanding of the test despite earlier competence ask the subject to show you explain to you how they arrived at the response that they just offered you Often this will reveal that they have mentally shifted to an incorrect understanding of the task requirements e g they may be choosing lines based on the distance between them rather than spatial orientation Reinstruct as ne
30. t happens that my movements awake 0 No 1 Yes 7 IN 8 After awakening mostly remember the content of my dreams well 0 No 1 Yes 9 My sleep is frequently disturbed 0 No 1 Yes 9 Stiasny Kolster K et al The REM Sleep Behavior Disorder Screening Questionnaire A New 5 6 10 Page 1 of 2 Diagnostic Instrument Movement Disorders 2007 22 16 2386 2393 PPMI REM SLEEP DISORDER QUESTIONNAIRE SUBJECT ID VISIT NO 10 I have had a disease of the nervous system 0 No 1 Yes 10a stroke 10b head trauma 10c parkinsonism 10d RLS 10e narcolepsy 10f depression 10g epilepsy 10h inflammatory disease of the brain 10i other specify Stiasny Kolster K et al The REM Sleep Behavior Disorder Screening Questionnaire A New 5 6 10 Diagnostic Instrument Movement Disorders 2007 22 16 2386 2393 ag Page 2 of 2 PPMI GERIATRIC DEPRESSION SCALE Short Version MM DD Choose the best answer for how you have felt over the past week 0 No 1 Yes Are you basically satisfied with your life 2 Have you dropped many of your activities and interests 3 Do you feel that your life is empty 4 Do you often get bored 5 Are you in good spirits most of the time 6 Are you afraid that something bad is going to happen to you 7 Do you feel happy most of the time 8 Do you often feel helpless 9 Do you prefer to stay at home rather than going out and doing
31. t unique animal names produced within 60 seconds gt CREDIT breeds e g terriers male female and infant names of a species e g bull cow calf both superordinate and subordinate examples of a species e g both dog and terrier are credited birds fish reptiles insects DONOT CREDIT Repetitions mythical animals Vegetable total number of correct unique names of vegetables produced within 60 seconds gt CREDIT Both superordinate and subordinate responses e g peppers and jalapenos are credited less specific names e g greens nuts e g peanuts acorns and grains such as corn or rice o Names of vegetables found in other cultures but perhaps unfamiliar to you e g Jicama are acceptable only if they can be verified in the dictionary o After completion of the task ask the subject to spell the word if you are unsure of the correct spelling amp wish to check on the item o Grains e g rice wheat oats etc gourds sugarcane herbs and seaweed are counted as acceptable vegetable responses o Tomato avocado and pumpkin are acceptable responses DO NOT CREDIT Repetitions Prepared vegetable products are not acceptable responses e g pickles tomato sauce ketchup etc Fruit Total number of correct unique names of fruits produced within 60 seconds Some items e g tomato avocado count as either a fruit or vegetable but you should only give credit once i e if the subject gives
32. tomato as vegetable and then again as a fruit do not give credit the second time Count raisins amp sultanas as well as grapes If you are uncertain of a response after the completion of the trial ask the subject to spell the item so that you can check it in the dictionary amp or obtain opinions from other examiners v 05 05 10 PPMI SEMANTIC FLUENCY ANIMALS Site Number Subject Number Visit Date NAME AS MANY ANIMALS AS YOU CAN IN 60 SECONDS Examiners Write responses verbatim whenever possible substitute checkmark only when you cannot keep up Do not count repetitions One prompt allowed if no response for 15 seconds or patient states they cannot think of any more Please tell me all the animals you can think of See Operations Manual for full instructions 1 16 31 2 17 32 3 18 33 4 19 34 5 20 35 6 21 36 7 22 37 8 23 38 9 24 39 10 25 40 11 26 41 12 27 42 13 28 43 14 29 44 15 30 45 04 27 10 PPMI SEMANTIC FLUENCY VEGETABLES Site Number Subject Number Visit Date NAME AS MANY VEGETABLES AS YOU CAN IN 60 SECONDS Examiners Write responses verbatim whenever possible substitute checkmark only when you cannot keep up Do not count repetitions One prompt allowed if no response for 15 seconds or patient states they cannot think of any more Please tell me all the vegetables you can think of See Operations Manua
33. trials SAY I am going to say a group of numbers and letters After I say them I want you to repeat the numbers first in order starting with the lowest number Then say the letters in alphabetical order For example if I say B 7 your answer should be 7 The number goes first then the letter If I say 9 C 3 then your answer should be 3 9 C the numbers in order first then the letters in alphabetical order LET S PRACTICE correct responses are in parentheses READ AT A RATE OF ABOUT ONE NUMBER OR LETTER PER SECOND 6 F 6 F G 4 4 G 3 W 5 3 5 W pen bee If the subject makes error on a practice correct him her and repeat the instructions This test can be confusing for subjects with cognitive decline and it may take a little effort to help them understand it HOWEVER even if the subject fails all practice items you must go ahead with the test DISCONTINUE if a subject scores a 0 on all three trials of an item e g 0 for 3b and 3c Scoring Record the subject s response to each trial verbatim next to the item on the worksheet A response is incorrect if a number or letter is omitted or if the numbers and letters are not said in the specified sequence e As long as the numbers and letters are recalled in correct sequence give credit if the examinee gives the letters before the numbers even though this is counter to th
34. va dribbled out of your mouth never sometimes regularly often 3 In the past month has food ever become stuck in your throat never sometimes regularly often 4 In the past month did you ever have the feeling during a meal that you were full very quickly B never sometimes regularly often 5 Constipation is a blockage of the bowel a condition in which someone has a bowel movement twice a week or less In the past month have you had problems with constipation E E E E never sometimes regularly often 6 In the past month did you have to strain hard to pass stools never sometimes regularly often PPMI Page 2 of 5 Js In the past month have you had involuntary loss of stools never sometimes regularly often Questions 8 to 13 deal with problems with passing urine If you use a catheter you can indicate this by placing a cross in the box use catheter 8 In the past month have you had difficulty retaining urine never sometimes regularly often use catheter 9 In the past month have you had involuntary loss of urine never sometimes regularly often use catheter 10 In the past month have you had the feeling that after passing urine your bladder was not completely empty never sometimes regularly often use catheter 11 In the past month has the stream of urine been weak never sometimes regularly often use catheter 12 In the past month have you had to pass urine again within 2 hours of the previous time n
35. z T8 MM DD YYYY 1 Whole blood for storage and analysis 0 Not collected 1 Collected 1 1a Date of whole blood collection af I1LLICELTI MM DD YYYY 2 Comments Copyright 2007 University of Rochester All Rights Reserved 8 20 10 Page 1 of 1 PPMI MAGNETIC RESONANCE IMAGING MM DD YYYY 1 MRI scan 0 Not Completed 1 Completed 1 If Not Completed 0 provide reason in Comments 1a Date MHI scan completed NE DD YYYY 1b Did MRI scan include DTI sequences 0 No 1 Yes 1b 1c Did MRI scan include resting state sequences 0 No 1 Yes ic 2 MRI data transferred to the core imaging lab at Institute for Neurodegenerative 2 Disorders 0 No 1 Yes d MRI scan results based on radiologist interpretation are Baseline Only 3 j 1 Normal 2 Abnormal not clinically significant 3 Abnormal clinically significant specify in Comments Comments NOTE DTI sequences at Baseline and annual visits performed at select sites only Copyright 2010 University of Rochester All Rights Reserved 4 23 12 Page 1 of 1 PPMI LUMBAR PUNCTURE 16 4 YYYY A Date of last intake of food Th T Time of last intake of food 24 clock B I 1 Ba Fasting status Ba B 1 Fasted minimum of 8 hours 2 Low Fat Diet 3 Not Fasted No Low Fat Diet C Is subject on medication for PD 0 No 1 Yes C
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