A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | ||
1 | Visit Number | Screening | Baseline (BL) | V02 | V04 | V05 | V06 | R06 | V08 | R08 | V10 | R10 | V12 | bTransition Activities | HEvent Driven Modified Visit | ||
2 | Assessment | **Timepoint | -60 days | 0 | 6 mths | 12 (Y1) | 18 mths | 24 (Y2) | 30 mths | 36 (Y3) | 42 mths | 48 (Y4) | 54 mths | 60 (Y5) | --- | --- | |
3 | Consent Activities | ||||||||||||||||
4 | Documentation of Informed Consent | X | As Needed | X | |||||||||||||
5 | Continuing Consent | X | X | X | X | X | |||||||||||
6 | Research Proxy Designation | X | As Needed (X) | ||||||||||||||
7 | Consent to share contact information | X | As Needed | X | |||||||||||||
8 | Informed Consent Tracking Log | X | As Needed | X | |||||||||||||
9 | General Activities | ||||||||||||||||
10 | Demographics | X | |||||||||||||||
11 | Family History | X | |||||||||||||||
12 | Socio-Economics | X | |||||||||||||||
13 | Physical Examination | X | |||||||||||||||
14 | Program Assessment | ||||||||||||||||
15 | Vital Signs (Height and Weight BL + Annually) | X | X | X | X | X | X | X | X | X | |||||||
16 | Review Inclusion/Exclusion Criteria | I | I | ||||||||||||||
17 | Visit Status | X | |||||||||||||||
18 | Screen Fail | As Needed | As Needed | ||||||||||||||
19 | Conclusion of Study Participation | As Needed | |||||||||||||||
20 | Neurological/Motor Assessments | ||||||||||||||||
21 | Participant Motor Function Questionnaire | P | P | P | P | P | P | ||||||||||
22 | Freezing and Falls | X | X | X | X | X | X | ||||||||||
23 | Neurological Examination | I | I | I | I | I | I | I | |||||||||
24 | MDS-UPDRS Part Ia, Part III Treatment Determination/Motor Exam/Hoehn & Yahra | I | I | I | I | I | I | I | I | I | I | I | |||||
25 | MDS-UPDRS Part Ib and Part II | P | P | P | P | P | P | P | P | P | P | P | |||||
26 | Modified Schwab & England ADL | I | I | I | I | I | I | I | I | I | I | I | |||||
27 | Features of Parkinsonism | I | I | I | I | I | I | I | I | I | I | I | |||||
28 | Other Clinical Features | I | I | I | I | I | I | I | I | I | I | I | |||||
29 | Primary Research Diagnosis | I | I | I | I | I | I | I | I | I | I | I | |||||
30 | Clinical Diagnosis | X | X | X | X | X | X | X | X | X | X | X | |||||
31 | Non-Motor Assessments | ||||||||||||||||
32 | Olfactory Testing (UPSIT) | P | |||||||||||||||
33 | REM Sleep Behavior Disorder Screening Questionnaire | P | P | P | P | P | P | ||||||||||
34 | Epworth Sleepiness Scale | P | P | P | P | P | P | ||||||||||
35 | SCOPA-AUT | P | P | P | P | P | P | ||||||||||
36 | Neuro QoL | P | P | P | P | P | P | ||||||||||
37 | Cognitive Assessments | ||||||||||||||||
38 | Montreal Cognitive Assessment* | X | X | X | X | X | X | ||||||||||
39 | Clock Drawing* | X | X | X | X | X | X | ||||||||||
40 | Lexical Fluency* | X | X | X | X | X | X | ||||||||||
41 | Hopkins Verbal Learning Test-Revised* | X | X | X | X | X | X | ||||||||||
42 | Benton Judgment of Line Orientation* | X | X | X | X | X | X | ||||||||||
43 | Modified Semantic Fluency (Animals only)* | X | X | X | X | X | X | ||||||||||
44 | Letter Number Sequencing* | X | X | X | X | X | X | ||||||||||
45 | Symbol Digit Modalities Test* | X | X | X | X | X | X | ||||||||||
46 | Trail Making Test (A and B)* | X | X | X | X | X | X | ||||||||||
47 | Modified Boston Naming Test* | X | X | X | X | X | X | ||||||||||
48 | Cognitive Change | P | P | P | P | P | P | P | P | ||||||||
49 | Cognitive Categorization | I | I | I | I | I | I | ||||||||||
50 | Neuropsychological Assessments | ||||||||||||||||
51 | State-Trait Anxiety Inventory for Adults | P | P | P | P | P | P | ||||||||||
52 | Geriatric Depression Scale | P | P | P | P | P | P | ||||||||||
53 | QUIP | P | P | P | P | P | P | ||||||||||
54 | Clinical and Biological Samples | ||||||||||||||||
55 | Clinical Lab blood sample | X | |||||||||||||||
56 | Research Biosamples (blood + urine) | X | X | X | X | X | X | X | X | ||||||||
57 | Lumbar puncture | X | X | X | X | X | X | ||||||||||
58 | Skin biopsyd | X | X | X | Xc | ||||||||||||
59 | Imaging Activities | ||||||||||||||||
60 | Pregnancy Test (prior to tracer injection), if applicable | X | |||||||||||||||
61 | Dopamine Imaging | X | |||||||||||||||
62 | MRI | X | |||||||||||||||
63 | Safety and General Health | ||||||||||||||||
64 | #Adverse Events | X | X | X | X | X | X | X | |||||||||
65 | Adverse Event Telephone Assessment | X | X | X | X | X | X | X | |||||||||
66 | Current Medical Conditions Review | X | X | X | X | X | X | X | X | X | X | X | X | ||||
67 | Concomitant Medication Review | X | X | X | X | X | X | X | X | X | X | X | X | ||||
68 | Participation in Other Studies As Needed | As Needed | |||||||||||||||
69 | Report of Pregnancy | As Needed |
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | ||
1 | Visit Number | Screening | Baseline (BL) | V02 | V04 | V05 | V06 | R06 | V08 | R08 | V10 | R10 | V12 | bTransition Activities | HEvent Driven Modified Visit | ||
2 | Assessment | **Timepoint | -60 days | 0 | 6 mths | 12 (Y1) | 18 mths | 24 (Y2) | 30 mths | 36 (Y3) | 42 mths | 48 (Y4) | 54 mths | 60 (Y5) | --- | --- | |
3 | Consent Activities | ||||||||||||||||
4 | Documentation of Informed Consent | X | As Needed | X | |||||||||||||
5 | Continuing Consent | X | X | X | X | X | |||||||||||
6 | Research Proxy Designation | X | As Needed | X | |||||||||||||
7 | Consent to share contact information | X | As Needed | X | |||||||||||||
8 | Informed Consent Tracking Log | X | As Needed | X | |||||||||||||
9 | General Activities | ||||||||||||||||
10 | Demographics | X | X | ||||||||||||||
11 | Family History | X | X | ||||||||||||||
12 | Socio-Economics | X | X | ||||||||||||||
13 | Physical Examination | X | |||||||||||||||
14 | Program Assessment | X | X | X | X | X | X | X | X | X | |||||||
15 | Clinical Global Impression (CGI) | I | I | I | I | I | I | ||||||||||
16 | Vital Signs (Height and Weight BL + Annually) | X | X | X | X | X | X | X | X | X | |||||||
17 | Review Inclusion/Exclusion Criteria | I | I | ||||||||||||||
18 | Visit Status | X | X | X | X | X | X | X | X | X | X | X | X | ||||
19 | Screen Fail | As Needed | As Needed | ||||||||||||||
20 | Conclusion of Study Participation | As Needed | |||||||||||||||
21 | Neurological/Motor Assessments | ||||||||||||||||
22 | Participant Motor Function Questionnaire | P | P | P | P | P | P | ||||||||||
23 | Freezing and Falls | X | X | X | X | X | X | ||||||||||
24 | PD Diagnosis History | I | |||||||||||||||
25 | Neurological Examination | I | I | I | I | I | I | ||||||||||
26 | Initiation of Dopaminergic Therapy | X | X | X | X | X | X | X | X | X | X | ||||||
27 | MDS-UPDRS Part Ia, Part III Treatment Determination/Motor Exam/Hoehn & Yahra,d | I | I | I | I | I | I | I | I | I | I | I | |||||
28 | MDS-UPDRS Part Ib and Part II | P | P | P | P | P | P | P | P | P | P | P | |||||
29 | Modified Schwab & England ADL | I | I | I | I | I | I | I | I | I | I | I | |||||
30 | MDS-UPDRS Part IVd | I | I | I | I | I | I | I | I | I | I | ||||||
31 | MDS-UPDRS Repeat Part III/Hoehn & Yahra,d | I | I | I | I | I | I | I | |||||||||
32 | Features of Parkinsonism | I | I | I | I | I | I | I | I | I | I | I | |||||
33 | Other Clinical Features | I | I | I | I | I | I | I | I | I | I | I | |||||
34 | Primary Research Diagnosis | I | I | I | I | I | I | I | I | I | I | I | |||||
35 | Clinical Diagnosis | X | X | X | X | X | X | X | X | X | X | X | |||||
36 | Non-Motor Assessments | ||||||||||||||||
37 | Olfactory Testing (UPSIT) | P | |||||||||||||||
38 | REM Sleep Behavior Disorder Screening Questionnaire | P | P | P | P | P | P | ||||||||||
39 | Epworth Sleepiness Scale | P | P | P | P | P | P | ||||||||||
40 | SCOPA-AUT | P | P | P | P | P | P | ||||||||||
41 | Participant Global Impression (PGI) | P | P | P | P | P | P | ||||||||||
42 | Neuro QoL | P | P | P | P | P | P | ||||||||||
43 | Cognitive Assessments | ||||||||||||||||
44 | Montreal Cognitive Assessment* | X | X | X | X | X | X | ||||||||||
45 | Clock Drawing* | X | X | X | X | X | X | ||||||||||
46 | Lexical Fluency* | X | X | X | X | X | X | ||||||||||
47 | Hopkins Verbal Learning Test-Revised* | X | X | X | X | X | X | ||||||||||
48 | Benton Judgment of Line Orientation* | X | X | X | X | X | X | ||||||||||
49 | Modified Semantic Fluency (Animals only)* | X | X | X | X | X | X | ||||||||||
50 | Letter Number Sequencing* | X | X | X | X | X | X | ||||||||||
51 | Symbol Digit Modalities Test* | X | X | X | X | X | X | ||||||||||
52 | Trail Making Test (A and B)* | X | X | X | X | X | X | ||||||||||
53 | Modified Boston Naming Test* | X | X | X | X | X | X | ||||||||||
54 | Cognitive Change | P | P | P | P | P | P | P | P | ||||||||
55 | Cognitive Categorization | I | I | I | I | I | I | ||||||||||
56 | Neuropsychological Assessments | ||||||||||||||||
57 | State-Trait Anxiety Inventory for Adults | P | P | P | P | P | P | ||||||||||
58 | Geriatric Depression Scale | P | P | P | P | P | P | ||||||||||
59 | QUIP | P | P | P | P | P | P | ||||||||||
60 | Clinical and Biological Samples | ||||||||||||||||
61 | Clinical Lab blood sample | X | |||||||||||||||
62 | Research Biosamples (blood + urine) | X | X | X | X | X | X | X | X | ||||||||
63 | Lumbar puncture | X | X | X | X | X | X | ||||||||||
64 | Skin biopsyf | X | X | X | Xc | ||||||||||||
65 | Imaging Activities | ||||||||||||||||
66 | Pregnancy Test (prior to tracer injection), if applicable | X | X | X | X | ||||||||||||
67 | Dopamine Imaging | X | X | X | X | ||||||||||||
68 | MRI | X | X | X | X | ||||||||||||
69 | Safety and General Health | ||||||||||||||||
70 | #Adverse Events | X | X | X | X | X | X | X | |||||||||
71 | Adverse Event Telephone Assessment | X | X | X | X | X | X | X | |||||||||
72 | Current Medical Conditions Review | X | X | X | X | X | X | X | X | X | X | X | X | ||||
73 | Concomitant Medication Review | X | X | X | X | X | X | X | X | X | X | X | X | ||||
74 | LEDD Concomitant Medication Log | As Needed | |||||||||||||||
75 | Participation in Other Studies | As Needed | |||||||||||||||
76 | Surgery for PD Log | As Needed | |||||||||||||||
77 | Report of Pregnancy | As Needed |
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | ||
1 | Visit Number | SC (SPECT) | BL (Clinic) | R01 | V04 | R04 | V06 | R06 | V08 | R08 | V10 | R10 | V12 | bTransition Activities | HEvent Driven Modified Visit | ||
2 | Assessment | **Timepoint | -60 days | 0 | 6 mths | 12 (Y1) | 18 mths | 24 (Y2) | 30 mths | 36 (Y3) | 42 mths | 48 (Y4) | 54 mths | 60 (Y5) | --- | --- | |
3 | Consent Activities | ||||||||||||||||
4 | Documentation of Prodromal Screening Consent | X | |||||||||||||||
5 | Documentation of Informed Consent | X | As Needed | X | |||||||||||||
6 | Continuing Consent | X | X | X | X | X | |||||||||||
7 | Research Proxy Designation | X | As Needed | X | |||||||||||||
8 | Consent to share contact information | X | As Needed | X | |||||||||||||
9 | Informed Consent Tracking Log | X | X | As Needed | |||||||||||||
10 | Pre-Screening Activities | ||||||||||||||||
11 | Prodromal History | X | |||||||||||||||
12 | Olfactory Testing (UPSIT) | P g | |||||||||||||||
13 | General Activities | ||||||||||||||||
14 | Demographics | X | X | ||||||||||||||
15 | Family History | X | X | ||||||||||||||
16 | Socio-Economics | X | X | ||||||||||||||
17 | Physical Examination | X | |||||||||||||||
18 | Vital Signs (Height and Weight BL + Annually) | X | X | X | X | X | X | ||||||||||
19 | Review Inclusion/Exclusion Criteria | I | I | ||||||||||||||
20 | Program Assessment | X | X | X | X | X | X | X | X | X | X | X | |||||
21 | Clinical Global Impression (CGI) | I | I | I | I | I | I | ||||||||||
22 | Visit Status | X | X | X | X | X | X | X | X | X | X | X | X | ||||
23 | Screen Fail | As Needed | As Needed | ||||||||||||||
24 | Conclusion of Study Participation | As Needed | |||||||||||||||
25 | Neurological/Motor Assessments | ||||||||||||||||
26 | Participant Motor Function Questionnaire | P | P | P | P | P | P | ||||||||||
27 | Freezing and Falls | X | X | X | X | X | X | ||||||||||
28 | Neurological Examination | I | I | I | I | I | I | ||||||||||
29 | Initiation of Dopaminergic Therapy | X | X | X | X | X | X | X | X | X | |||||||
30 | MDS-UPDRS Part Ia, Part III Treatment Determination/Motor Exam/Hoehn & Yahra,d | I | I | I | I | I | I | I | I | I | I | ||||||
31 | MDS-UPDRS Part Ib and Part II | P | P | P | P | P | P | P | P | P | P | P | |||||
32 | Modified Schwab & England ADL | I | I | I | I | I | I | I | I | I | I | I | |||||
33 | MDS-UPDRS Part IVd | I | I | I | I | I | I | I | I | I | I | ||||||
34 | MDS-UPDRS Repeat Part III/Hoehn & Yahra,d | I | I | I | I | I | |||||||||||
35 | Features of Parkinsonism | I | I | I | I | I | I | I | I | I | I | I | |||||
36 | Other Clinical Features | I | I | I | I | I | I | I | I | I | I | I | |||||
37 | Primary Research Diagnosis | I | I | I | I | I | I | I | I | I | I | I | |||||
38 | Clinical Diagnosis | X | X | X | X | X | X | X | X | X | X | X | |||||
39 | Non-Motor Assessments | ||||||||||||||||
40 | Olfactory Testing (UPSIT) | P | P | P | P | P | |||||||||||
41 | REM Sleep Behavior Disorder Screening Questionnaire | P | P | P | P | P | P | ||||||||||
42 | Epworth Sleepiness Scale | P | P | P | P | P | P | ||||||||||
43 | SCOPA-AUT | P | P | P | P | P | P | ||||||||||
44 | Participant Global Impression (PGI) | P | P | P | P | P | P | ||||||||||
45 | Neuro QoL | P | P | P | P | P | P | ||||||||||
46 | Cognitive Assessments | ||||||||||||||||
47 | Montreal Cognitive Assessment* | X | X | X | X | X | X | ||||||||||
48 | Clock Drawing* | X | X | X | X | X | X | ||||||||||
49 | Lexical Fluency* | X | X | X | X | X | X | ||||||||||
50 | Hopkins Verbal Learning Test-Revised* | X | X | X | X | X | X | ||||||||||
51 | Benton Judgment of Line Orientation* | X | X | X | X | X | X | ||||||||||
52 | Modified Semantic Fluency (Animals only)* | X | X | X | X | X | X | ||||||||||
53 | Letter Number Sequencing* | X | X | X | X | X | X | ||||||||||
54 | Symbol Digit Modalities Test* | X | X | X | X | X | X | ||||||||||
55 | Trail Making Test (A and B)* | X | X | X | X | X | X | ||||||||||
56 | Modified Boston Naming Test* | X | X | X | X | X | X | ||||||||||
57 | Cognitive Change | P | P | P | P | P | P | ||||||||||
58 | Cognitive Categorization | I | I | I | I | I | I | ||||||||||
59 | Neuropsychological Assessments | ||||||||||||||||
60 | State-Trait Anxiety Inventory for Adults | P | P | P | P | P | P | ||||||||||
61 | Geriatric Depression Scale | P | P | P | P | P | P | ||||||||||
62 | QUIP | P | P | P | P | P | P | ||||||||||
63 | Clinical and Biological Samples | ||||||||||||||||
64 | Clinical Lab blood sample | X | Xj | ||||||||||||||
65 | Research Biosamples | XM | X | X | X | X | X | X | |||||||||
66 | Lumbar puncture | X | X | X | X | X | X | ||||||||||
67 | Skin biopsyf | X | Xj | X | X | Xc | |||||||||||
68 | Imaging Activities | ||||||||||||||||
69 | Pregnancy Test (prior to tracer injection), if applicable | X | X | X | X | ||||||||||||
70 | Dopamine Imaging | X | X | X | X | ||||||||||||
71 | MRI | X | X | X | X | ||||||||||||
72 | Safety and General Health | ||||||||||||||||
73 | #Adverse Events | X | X | ||||||||||||||
74 | Adverse Event Telephone Assessment | X | X | ||||||||||||||
75 | Current Medical Conditions Review | As Needed | X | X | X | X | X | X | X | X | X | X | X | ||||
76 | Concomitant Medication Review | X | X | X | X | X | X | X | X | X | X | X | X | ||||
77 | Participation in Other Studies | As Needed | |||||||||||||||
78 | LEDD Concomitant Medication Log | As Needed | |||||||||||||||
79 | Surgery for PD Log | As Needed | |||||||||||||||
80 | Report of Pregnancy | As Needed |
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | ||
1 | Visit Number | R12 | V13 | R13 | V14 | R14 | V15 | R15 | V16 | R16 | V17 | R17 | V18 | R18 | V19 | R19 | Annual | Remote | bTransition Activities | HEvent Driven Modified Visit | ||
2 | Assessment | **Timepoint | 66 mths | 72 (Y6) | 78 mths | 84 (Y7) | 90 mths | 96 (Y8) | 102 mths | 108 (Y9) | 114 mths | 120 (Y10) | 126 mths | 132 (Y11) | 138 mths | 144 (Y12) | 150 mths | 156+ (Y13+) | 162 mths+ | --- | --- | |
3 | Consent Activities | |||||||||||||||||||||
4 | Documentation of Informed Consent | As Needed | X | |||||||||||||||||||
5 | Continuing Consent | X | X | X | X | X | X | X | X | |||||||||||||
6 | Consent to share contact information | As Needed | ||||||||||||||||||||
7 | Research Proxy Designation | As Needed | ||||||||||||||||||||
8 | Informed Consent Tracking Log | As Needed | ||||||||||||||||||||
9 | General Activities | |||||||||||||||||||||
10 | Demographics | X | ||||||||||||||||||||
11 | Family History | X | ||||||||||||||||||||
12 | Socio-Economics | X | ||||||||||||||||||||
13 | Program Assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
14 | Vital Signs + Height and Weight | X | X | X | X | X | X | X | X | |||||||||||||
15 | Visit Status | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
16 | Screen Fail | As Needed | ||||||||||||||||||||
17 | Conclusion of Study Participation | As Needed | ||||||||||||||||||||
18 | Neurological/Motor Assessments | |||||||||||||||||||||
19 | Participant Motor Function Questionnaire | P | P | P | P | P | P | P | P | |||||||||||||
20 | Freezing and Falls | X | X | X | X | X | X | X | X | |||||||||||||
21 | Neurological Examination | I | I | I | I | I | I | I | I | |||||||||||||
22 | MDS-UPDRS Part Ia, Part III Treatment Determination/Motor Exam/Hoehn & Yahra | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
23 | MDS-UPDRS Part Ib and Part II | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | ||||
24 | Modified Schwab & England ADL | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
25 | Features of Parkinsonism | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
26 | Other Clinical Features | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
27 | Primary Research Diagnosis | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
28 | Clinical Diagnosis | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
29 | Non-Motor Assessments | |||||||||||||||||||||
30 | REM Sleep Behavior Disorder Screening Questionnaire | P | P | P | P | P | P | P | P | |||||||||||||
31 | Epworth Sleepiness Scale | P | P | P | P | P | P | P | P | |||||||||||||
32 | SCOPA-AUT | P | P | P | P | P | P | P | P | |||||||||||||
33 | Neuro QoL | P | P | P | P | P | P | P | P | |||||||||||||
34 | Cognitive Assessments | |||||||||||||||||||||
35 | Montreal Cognitive Assessment* | X | X | X | X | X | X | X | X | |||||||||||||
36 | Clock Drawing* | X | X | X | X | X | X | X | X | |||||||||||||
37 | Lexical Fluency* | X | X | X | X | X | X | X | X | |||||||||||||
38 | Hopkins Verbal Learning Test-Revised* | X | X | X | X | X | X | X | X | |||||||||||||
39 | Benton Judgment of Line Orientation* | X | X | X | X | X | X | X | X | |||||||||||||
40 | Modified Semantic Fluency (Animals only)* | X | X | X | X | X | X | X | X | |||||||||||||
41 | Letter Number Sequencing* | X | X | X | X | X | X | X | X | |||||||||||||
42 | Symbol Digit Modalities Test* | X | X | X | X | X | X | X | X | |||||||||||||
43 | Trail Making Test (A and B)* | X | X | X | X | X | X | X | X | |||||||||||||
44 | Modified Boston Naming Test* | X | X | X | X | X | X | X | X | |||||||||||||
45 | Cognitive Change | P | P | P | P | P | P | P | P | |||||||||||||
46 | Cognitive Categorization | I | I | I | I | I | I | I | I | |||||||||||||
47 | Neuropsychological Assessments | |||||||||||||||||||||
48 | State-Trait Anxiety Inventory for Adults | P | P | P | P | P | P | P | P | |||||||||||||
49 | Geriatric Depression Scale | P | P | P | P | P | P | P | P | |||||||||||||
50 | QUIP | P | P | P | P | P | P | P | P | |||||||||||||
51 | Clinical and Biological Samples | |||||||||||||||||||||
52 | Research Biosamples (blood + urine) | X | X | X | X | X | X | X | X | |||||||||||||
53 | Lumbar puncture | X | X | X | X | X | X | |||||||||||||||
54 | Skin biopsyd | Xc | ||||||||||||||||||||
55 | Safety and General Health | |||||||||||||||||||||
56 | #Adverse Events | X | X | X | X | |||||||||||||||||
57 | Adverse Event Telephone Assessment | X | X | X | X | |||||||||||||||||
58 | Current Medical Conditions Review | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
59 | Concomitant Medication Review | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
60 | Participation in Other Studies | As Needed | ||||||||||||||||||||
61 | Report of Pregnancy | As Needed |
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | ||
1 | Visit Number | R12 | V13 | R13 | V14 | R14 | V15 | R15 | V16 | R16 | V17 | R17 | V18 | R18 | V19 | R19 | Annual | Remote | bTransition Activities | HEvent Driven Modified Visit | ||
2 | Assessment | **Timepoint | 66 mths | 72 (Y6) | 78 mths | 84 (Y7) | 90 mths | 96 (Y8) | 102 mths | 108 (Y9) | 114 mth | 120 (Y10) | 126 mths | 132 (Y11) | 138 mths | 144 (Y12) | 150 mths | 156+ (Y13+) | 162 mths+ | --- | --- | |
3 | Consent Activities | |||||||||||||||||||||
4 | Documentation of Informed Consent | As Needed | X | |||||||||||||||||||
5 | Continuing Consent | X | X | X | X | X | X | X | X | |||||||||||||
6 | Consent to share contact information | As Needed | ||||||||||||||||||||
7 | Research Proxy Designation | As Needed | ||||||||||||||||||||
8 | Informed Consent Tracking Log | As Needed | ||||||||||||||||||||
9 | General Activities | |||||||||||||||||||||
10 | Demographics | X | ||||||||||||||||||||
11 | Family History | X | ||||||||||||||||||||
12 | Socio-Economics | X | ||||||||||||||||||||
13 | Program Assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
14 | Clinical Global Impression (CGI) | I | I | I | I | I | I | I | I | |||||||||||||
15 | Vital Signs + Height and Weight | X | X | X | X | X | X | X | X | |||||||||||||
16 | Visit Status | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
17 | Screen Fail | As Needed | ||||||||||||||||||||
18 | Conclusion of Study Participation | As Needed | ||||||||||||||||||||
19 | Neurological/Motor Assessments | |||||||||||||||||||||
20 | Participant Motor Function Questionnaire | P | P | P | P | P | P | P | P | |||||||||||||
21 | Freezing and Falls | X | X | X | X | X | X | X | X | |||||||||||||
22 | Neurological Examination | I | I | I | I | I | I | I | I | |||||||||||||
23 | Initiation of Dopaminergic Therapy | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
24 | MDS-UPDRS Part Ia, Part III Treatment Determination/Motor Exam/Hoehn & Yahra,d | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | |||||
25 | MDS-UPDRS Part Ib and Part II | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | |||||
26 | Modified Schwab & England ADL | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
27 | MDS-UPDRS Part IVd | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
28 | MDS-UPDRS Repeat Part III/Hoehn & Yahra, d | I | I | I | I | I | I | I | I | |||||||||||||
29 | Features of Parkinsonism | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
30 | Other Clinical Features | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
31 | Primary Research Diagnosis | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
32 | Clinical Diagnosis | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
33 | Non-Motor Assessments | |||||||||||||||||||||
34 | REM Sleep Behavior Disorder Screening Questionnaire | P | P | P | P | P | P | P | ||||||||||||||
35 | Epworth Sleepiness Scale | P | P | P | P | P | P | P | P | |||||||||||||
36 | SCOPA-AUT | P | P | P | P | P | P | P | P | |||||||||||||
37 | Participant Global Impression (PGI) | P | P | P | P | P | P | P | P | |||||||||||||
38 | Neuro QoL | P | P | P | P | P | P | P | P | |||||||||||||
39 | Cognitive Assessments | |||||||||||||||||||||
40 | Montreal Cognitive Assessment* | X | X | X | X | X | X | X | X | |||||||||||||
41 | Clock Drawing* | X | X | X | X | X | X | X | X | |||||||||||||
42 | Lexical Fluency* | X | X | X | X | X | X | X | X | |||||||||||||
43 | Hopkins Verbal Learning Test-Revised* | X | X | X | X | X | X | X | X | |||||||||||||
44 | Benton Judgment of Line Orientation* | X | X | X | X | X | X | X | X | |||||||||||||
45 | Modified Semantic Fluency (Animals only)* | X | X | X | X | X | X | X | X | |||||||||||||
46 | Letter Number Sequencing* | X | X | X | X | X | X | X | X | |||||||||||||
47 | Symbol Digit Modalities Test* | X | X | X | X | X | X | X | X | |||||||||||||
48 | Trail Making Test (A and B)* | X | X | X | X | X | X | X | X | |||||||||||||
49 | Modified Boston Naming Test* | X | X | X | X | X | X | X | X | |||||||||||||
50 | Cognitive Change | P | P | P | P | P | P | P | P | |||||||||||||
51 | Cognitive Categorization | I | I | I | I | I | I | I | I | |||||||||||||
52 | Neuropsychological Assessments | |||||||||||||||||||||
53 | State-Trait Anxiety Inventory for Adults | P | P | P | P | P | P | P | P | |||||||||||||
54 | Geriatric Depression Scale | P | P | P | P | P | P | P | P | |||||||||||||
55 | QUIP | P | P | P | P | P | P | P | P | |||||||||||||
56 | Clinical and Biological Samples | |||||||||||||||||||||
57 | Research Biosamples (blood + urine) | X | X | X | X | X | X | X | X | |||||||||||||
58 | Lumbar puncture | X | X | X | X | |||||||||||||||||
59 | Skin biopsyf | X c | ||||||||||||||||||||
60 | Safety and General Health | |||||||||||||||||||||
61 | #Adverse Events | X | X | X | X | |||||||||||||||||
62 | Adverse Event Telephone Assessment | X | X | X | X | |||||||||||||||||
63 | Current Medical Conditions Review | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
64 | Concomitant Medication Review | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
65 | Participation in Other Studies | As Needed | ||||||||||||||||||||
66 | LEDD Concomitant Medication Log | As Needed | ||||||||||||||||||||
67 | Surgery for PD Log | As Needed | ||||||||||||||||||||
68 | Report of Pregnancy | As Needed |
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | ||
1 | Visit Number | R12 | V13 | R13 | V14 | R14 | V15 | R15 | V16 | R16 | V17 | R17 | V18 | R18 | V19 | R19 | Annual | Remote | bTransition Activities | HEvent Driven Modified Visit | ||
2 | Assessment | **Timepoint | 66 mths | 72 (Y6) | 78 mths | 84 (Y7) | 90 mths | 96 (Y8) | 102 mths | 108 (Y9) | 114 mth | 120 (Y10) | 126 mths | 132 (Y11) | 138 mths | 144 (Y12) | 150 mths | 156+ (Y13+) | 162 mths+ | --- | --- | |
3 | Consent Activities | |||||||||||||||||||||
4 | Documentation of Informed Consent | As Needed | X | |||||||||||||||||||
5 | Continuing Consent | X | X | X | X | X | X | X | X | |||||||||||||
6 | Consent to share contact information | As Needed | ||||||||||||||||||||
7 | Research Proxy Designation | As Needed | ||||||||||||||||||||
8 | Informed Consent Tracking Log | |||||||||||||||||||||
9 | General Activities | |||||||||||||||||||||
10 | Demographics | X | ||||||||||||||||||||
11 | Family History | X | ||||||||||||||||||||
12 | Socio-Economics | X | ||||||||||||||||||||
13 | Program Assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
14 | Clinical Global Impression (CGI) | I | I | I | I | I | I | I | I | |||||||||||||
15 | Vital Signs + Height and Weight | X | X | X | X | X | X | X | X | |||||||||||||
16 | Visit Status | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
17 | Screen Fail | As Needed | ||||||||||||||||||||
18 | Conclusion of Study Participation | As Needed | ||||||||||||||||||||
19 | Neurological/Motor Assessments | |||||||||||||||||||||
20 | Participant Motor Function Questionnaire | P | P | P | P | P | P | P | P | |||||||||||||
21 | Freezing and Falls | X | X | X | X | X | X | X | X | |||||||||||||
22 | Neurological Examination | I | I | I | I | I | I | I | I | |||||||||||||
23 | Initiation of Dopaminergic Therapy | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
24 | MDS-UPDRS Part Ia, Part III Treatment Determination/Motor Exam/Hoehn & Yahra,d | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | |||||
25 | MDS-UPDRS Part Ib and Part II | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | P | ||||
26 | Modified Schwab & England ADL | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
27 | MDS-UPDRS Part IVd | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
28 | MDS-UPDRS Repeat Part III/Hoehn & Yahra, d | I | I | I | I | I | I | I | I | |||||||||||||
29 | Features of Parkinsonism | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
30 | Other Clinical Features | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
31 | Primary Research Diagnosis | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | I | ||||
32 | Clinical Diagnosis | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
33 | Non-Motor Assessments | |||||||||||||||||||||
34 | REM Sleep Behavior Disorder Screening Questionnaire | P | P | P | P | P | P | P | ||||||||||||||
35 | Epworth Sleepiness Scale | P | P | P | P | P | P | P | P | |||||||||||||
36 | SCOPA-AUT | P | P | P | P | P | P | P | P | |||||||||||||
37 | Participant Global Impression (PGI) | P | P | P | P | P | P | P | P | |||||||||||||
38 | Neuro QoL | P | P | P | P | P | P | P | P | |||||||||||||
39 | Cognitive Assessments | |||||||||||||||||||||
40 | Montreal Cognitive Assessment* | X | X | X | X | X | X | X | X | |||||||||||||
41 | Clock Drawing* | X | X | X | X | X | X | X | X | |||||||||||||
42 | Lexical Fluency* | X | X | X | X | X | X | X | X | |||||||||||||
43 | Hopkins Verbal Learning Test-Revised* | X | X | X | X | X | X | X | X | |||||||||||||
44 | Benton Judgment of Line Orientation* | X | X | X | X | X | X | X | X | |||||||||||||
45 | Modified Semantic Fluency (Animals only)* | X | X | X | X | X | X | X | X | |||||||||||||
46 | Letter Number Sequencing* | X | X | X | X | X | X | X | X | |||||||||||||
47 | Symbol Digit Modalities Test* | X | X | X | X | X | X | X | X | |||||||||||||
48 | Trail Making Test (A and B)* | X | X | X | X | X | X | X | X | |||||||||||||
49 | Modified Boston Naming Test* | X | X | X | X | X | X | X | X | |||||||||||||
50 | Cognitive Change | P | P | P | P | P | P | P | P | |||||||||||||
51 | Cognitive Categorization | I | I | I | I | I | I | I | I | |||||||||||||
52 | Neuropsychological Assessments | |||||||||||||||||||||
53 | State-Trait Anxiety Inventory for Adults | P | P | P | P | P | P | P | P | |||||||||||||
54 | Geriatric Depression Scale | P | P | P | P | P | P | P | P | |||||||||||||
55 | QUIP | P | P | P | P | P | P | P | P | |||||||||||||
56 | Clinical and Biological Samples | |||||||||||||||||||||
57 | Research Biosamples (blood + urine) | X | X | X | X | X | X | X | X | |||||||||||||
58 | Lumbar puncture | X | X | X | X | |||||||||||||||||
59 | Skin biopsyf | X c | ||||||||||||||||||||
60 | Safety and General Health | |||||||||||||||||||||
61 | #Adverse Events | X | X | X | X | |||||||||||||||||
62 | Adverse Event Telephone Assessment | X | X | X | X | |||||||||||||||||
63 | Current Medical Conditions Review | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
64 | Concomitant Medication Review | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
65 | Participation in Other Studies | As Needed | ||||||||||||||||||||
66 | LEDD Concomitant Medication Log | As Needed | ||||||||||||||||||||
67 | Surgery for PD Log | As Needed | ||||||||||||||||||||
68 | Report of Pregnancy | As Needed |
A | B | |
CENTRAL LAB TESTS | ||
METABOLIC PANEL | COMPLETE BLOOD COUNT | |
Sodium (Na) | White Blood Cell Count (WBC) | |
Potassium (K) | Red Blood Cell Count (RBC) | |
Chloride (Cl) | Hemoglobin (Hb) | |
Carbon Dioxide (CO2) | Hematocrit (HCT) | |
Blood Urea Nitrogen (BUN) | Platelet Count (PLT) | |
Glucose | ||
Calcium (Ca) | ||
Creatinine (Crn) | ||
Bilirubin Total | ||
Albumin | ||
Total Protein | ||
Aspartate aminotransferase (AST) | ||
Alanine aminotransferase (ALT) | ||
Alkaline Phosphatase (ALKP) | ||
Uric Acid | ||
Prothrombin time (PT) – Screening Only | ||
Partial Thromboplastin Time (PTT) – Screening Only |