Trial Outcomes & Findings for Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials (NCT NCT03538262)
NCT ID: NCT03538262
Last Updated: 2023-06-12
Results Overview
Participants will be asked to complete (from home or other preferred environment) an hour-long Tele-visit that includes the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), comprising MDS-UPDRS part 1a and (modified) part 3, as well as completion or confirmation of patient-reported component parts 1b and 2. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features. Parts I-III contain 59 total questions (13 in Part I, 13 in Part II, and 33 in Part III). Total scores are calculated as simple sums of component items with mean imputation by Part if no more than 1, 2, or 7 items are missing for Parts I through III, respectively. Total scores may range from 0 to 236, with 0 meaning no symptoms and 236 meaning worse symptoms.
COMPLETED
226 participants
Two years (0, 12, and 24 months)
2023-06-12
Participant Flow
Participant milestones
| Measure |
Former Phase 3 PD Trial Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Overall Study
STARTED
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226
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Overall Study
COMPLETED
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203
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Overall Study
NOT COMPLETED
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23
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not complete MDS-UPDRS parts 1B and 2, which were administered as surveys via REDCap, at the baseline visit. Hence this participant does not have a baseline score for MDS-UPDRS Part I.
Baseline characteristics by cohort
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Age, Continuous
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64.7 years
STANDARD_DEVIATION 8.8 • n=226 Participants
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Sex: Female, Male
Female
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90 Participants
n=226 Participants
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Sex: Female, Male
Male
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136 Participants
n=226 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=226 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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220 Participants
n=226 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=226 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=226 Participants
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Race (NIH/OMB)
Asian
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4 Participants
n=226 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=226 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=226 Participants
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Race (NIH/OMB)
White
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215 Participants
n=226 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=226 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=226 Participants
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Age at symptom onset
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59.4 years
STANDARD_DEVIATION 9.1 • n=226 Participants
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Years from symptom onset to baseline
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5.30 years
STANDARD_DEVIATION 1.95 • n=226 Participants
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Age at diagnosis
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60.9 years
STANDARD_DEVIATION 8.9 • n=226 Participants
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Years from diagnosis to baseline
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3.82 years
STANDARD_DEVIATION 1.19 • n=226 Participants
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Use of antiparkinsonian medications
No
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16 Participants
n=226 Participants
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Use of antiparkinsonian medications
Yes
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210 Participants
n=226 Participants
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Use of levodopa
No
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62 Participants
n=226 Participants
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Use of levodopa
Yes
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164 Participants
n=226 Participants
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MDS-UPDRS Part I
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7.54 units on a scale
STANDARD_DEVIATION 4.84 • n=225 Participants • One participant did not complete MDS-UPDRS parts 1B and 2, which were administered as surveys via REDCap, at the baseline visit. Hence this participant does not have a baseline score for MDS-UPDRS Part I.
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MDS-UPDRS Part Ia
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1.46 units on a scale
STANDARD_DEVIATION 2.10 • n=226 Participants
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MDS-UPDRS Part Ib
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6.08 units on a scale
STANDARD_DEVIATION 3.40 • n=225 Participants • One participant did not complete MDS-UPDRS parts 1B and 2, which were administered as surveys via REDCap, at the baseline visit.
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MDS-UPDRS Part II
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8.60 units on a scale
STANDARD_DEVIATION 5.39 • n=225 Participants • One participant did not complete MDS-UPDRS parts 1B and 2, which were administered as surveys via REDCap, at the baseline visit.
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MDS-UPDRS Part III
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24.9 units on a scale
STANDARD_DEVIATION 11.5 • n=226 Participants
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MDS-UPDRS Parts I-III Total Score
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41.0 units on a scale
STANDARD_DEVIATION 16.5 • n=225 Participants • One participant did not complete MDS-UPDRS parts 1B and 2, which were administered as surveys via REDCap, at the baseline visit. Hence this participant does not have a baseline MDS-UPDRS Parts I-III total score.
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MDS-UPDRS Part IV
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2.42 units on a scale
STANDARD_DEVIATION 3.15 • n=202 Participants • 24 of the 226 participants are missing MDS-UPDRS Part 4 data at baseline.
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Hoehn & Yahr
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1.8 units on a scale
STANDARD_DEVIATION 0.4 • n=226 Participants
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Schwab & England Activities of Daily Living (ADL)
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89.7 units on a scale
STANDARD_DEVIATION 8.3 • n=226 Participants
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MoCA total score
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27.9 units on a scale
STANDARD_DEVIATION 2.0 • n=226 Participants
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Clinician Global Impression - Severity
1 = Normal, not at all incapacitated
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1 Participants
n=226 Participants
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Clinician Global Impression - Severity
2 = Borderline incapacitated
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60 Participants
n=226 Participants
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Clinician Global Impression - Severity
3 = Mildly incapacitated
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146 Participants
n=226 Participants
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Clinician Global Impression - Severity
4 = Moderately incapacitated
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19 Participants
n=226 Participants
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Smartphone Tapping (Score)
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0.627 score on a scale
STANDARD_DEVIATION 0.224 • n=178 Participants • The analysis only includes subjects who consented to smartphone assessments.
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Fox Insight MDS-UPDRS Part II Score
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7.978 score on a scale
STANDARD_DEVIATION 4.950 • n=93 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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Fox Insight PDQ-8 Score
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2.927 score on a scale
STANDARD_DEVIATION 2.925 • n=120 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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Fox Insight EQ-5D Score
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0.858 score on a scale
STANDARD_DEVIATION 0.132 • n=92 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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Fox Insight NMS-QUEST Score
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6.950 score on a scale
STANDARD_DEVIATION 4.136 • n=120 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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Fox Insight REM (Rapid Eye Movement) Behavior Disorder Score
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0.373 score on a scale
STANDARD_DEVIATION 0.487 • n=75 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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Fox Insight PDAQ-15 Score
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55.444 score on a scale
STANDARD_DEVIATION 4.965 • n=90 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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Fox Insight GDS Score
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1.830 score on a scale
STANDARD_DEVIATION 2.348 • n=78 Participants • This is a self-completed assessment. Only assessments completed on schedule are reported.
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PRIMARY outcome
Timeframe: Two years (0, 12, and 24 months)Participants will be asked to complete (from home or other preferred environment) an hour-long Tele-visit that includes the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), comprising MDS-UPDRS part 1a and (modified) part 3, as well as completion or confirmation of patient-reported component parts 1b and 2. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features. Parts I-III contain 59 total questions (13 in Part I, 13 in Part II, and 33 in Part III). Total scores are calculated as simple sums of component items with mean imputation by Part if no more than 1, 2, or 7 items are missing for Parts I through III, respectively. Total scores may range from 0 to 236, with 0 meaning no symptoms and 236 meaning worse symptoms.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score)
BL to Month 12
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2.197 score on a scale
Interval 0.634 to 3.759
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Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score)
BL to Month 24
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8.943 score on a scale
Interval 6.92 to 10.966
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PRIMARY outcome
Timeframe: Two years (0, 12, and 24 months)The Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) Part II score comprises patient-reported responses to 13 questions on motor experiences of daily living. The response to each question is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Part II scores may range from a minimum of 0 to a maximum of 52, with higher values meaning worse symptoms.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit MDS-UPDRS Part 2 (Score)
BL to Month 12
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0.575 score on a scale
Interval 0.134 to 1.017
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Change in Tele-visit MDS-UPDRS Part 2 (Score)
BL to Month 24
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1.550 score on a scale
Interval 0.992 to 2.107
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PRIMARY outcome
Timeframe: Two years (0, 3, 6, 9, 12 , 15, 18, 21, and 24 months)Population: Only subjects who consented and enrolled in the smartphone assessments are included in the analysis.
The Smartphone Tapping Score is derived from a 30-second finger tapping task performed separately for each hand. The score ranges from 0 to 1 and higher scores are worse.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=184 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Smartphone Tapping (Score)
BL to Month 3
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-0.051 score on a scale
Interval -0.088 to -0.014
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Change in Smartphone Tapping (Score)
BL to Month 6
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-0.088 score on a scale
Interval -0.122 to -0.053
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Change in Smartphone Tapping (Score)
BL to Month 9
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-0.057 score on a scale
Interval -0.096 to -0.019
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Change in Smartphone Tapping (Score)
BL to Month 12
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-0.078 score on a scale
Interval -0.108 to -0.049
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Change in Smartphone Tapping (Score)
BL to Month 15
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-0.106 score on a scale
Interval -0.138 to -0.075
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Change in Smartphone Tapping (Score)
BL to Month 18
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-0.116 score on a scale
Interval -0.149 to -0.082
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Change in Smartphone Tapping (Score)
BL to Month 21
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-0.114 score on a scale
Interval -0.15 to -0.077
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Change in Smartphone Tapping (Score)
BL to Month 24
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-0.139 score on a scale
Interval -0.175 to -0.102
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PRIMARY outcome
Timeframe: Two years (0, 6, 12, 18, and 24 months)The Fox Insight MDS-UPDRS (Movement Disorders Society Unified PD Rating Scale) Part II score comprises patient-reported responses to 13 questions on motor experiences of daily living. Participants report their responses online through the Fox Insight web-based platform. The response to each question is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Part II scores may range from a minimum of 0 to a maximum of 52, with higher values meaning worse symptoms.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=148 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Fox Insight MDS-UPDRS Part 2 (Score)
BL to Month 6
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-0.002 score on a scale
Interval -0.837 to 0.833
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Change in Fox Insight MDS-UPDRS Part 2 (Score)
BL to Month 12
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1.027 score on a scale
Interval -0.017 to 2.07
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Change in Fox Insight MDS-UPDRS Part 2 (Score)
BL to Month 18
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1.367 score on a scale
Interval 0.174 to 2.56
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Change in Fox Insight MDS-UPDRS Part 2 (Score)
BL to Month 24
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1.771 score on a scale
Interval 0.522 to 3.02
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SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)Participants will be asked to complete (from home or other preferred environment) an hour-long Tele-visit that includes the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), comprising MDS-UPDRS part 1a (i.e., the first six questions of part 1). The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features. Part 1a scores may range from a minimum of 0 to a maximum of 24, with higher values meaning worse disability.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit MDS-UPDRS Part 1a (Score)
BL to Month 12
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0.189 score on a scale
Interval -0.066 to 0.445
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Change in Tele-visit MDS-UPDRS Part 1a (Score)
BL to Month 24
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0.313 score on a scale
Interval 0.033 to 0.594
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SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)The Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) Part Ib is the patient-reported portion of Part I, and assesses non-motor experiences of daily living. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Part Ib contains 7 questions, and its scores may range from a minimum of 0 to a maximum of 28, with higher values meaning worse symptoms.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit MDS-UPDRS Part 1b (Score)
BL to Month 12
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1.026 score on a scale
Interval 0.667 to 1.384
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Change in Tele-visit MDS-UPDRS Part 1b (Score)
BL to Month 24
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1.238 score on a scale
Interval 0.864 to 1.613
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SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)Participants will be asked to complete (from home or other preferred environment) an hour-long Tele-visit that includes the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), comprising MDS-UPDRS (modified) part 3. This measure omits 5 questions related to rigidity and 1 question related to postural instability, with a range from 0 to 108. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit Modified MDS-UPDRS Part 3 (Score)
BL to Month 12
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0.457 score on a scale
Interval -0.572 to 1.486
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Change in Tele-visit Modified MDS-UPDRS Part 3 (Score)
BL to Month 24
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4.617 score on a scale
Interval 3.245 to 5.989
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SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)The Montreal Cognitive Assessment (MoCA) assesses attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Points are awarded for the correct completion of MoCA tasks. Scores for each task are summed for a total score (range 0-30). Higher scores indicate greater cognitive capacity.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit Montreal Cognitive Assessment (MoCA; Score)
BL to Month 12
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-0.051 score on a scale
Interval -0.301 to 0.199
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Change in Tele-visit Montreal Cognitive Assessment (MoCA; Score)
BL to Month 24
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0.142 score on a scale
Interval -0.124 to 0.408
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SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)The Schwab and England scale is a Site Investigator and subject assessment of the subject's level of independence. The subject will be scored on a percentage scale reflecting his/her ability to perform acts of daily living. Printed scores with associated descriptors range from 0% to 100% in increments of 5%, with higher percentages associated with more independence. A score of 0% implies "vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden". A score of 100% implies "subject has full ability and is completely independent; essentially normal".
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit Schwab and England (S&E; Score)
BL to Month 12
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-0.440 score on a scale
Interval -1.577 to 0.697
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Change in Tele-visit Schwab and England (S&E; Score)
BL to Month 24
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-0.338 score on a scale
Interval -1.495 to 0.818
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SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)The Clinician Global Impression (CGI) is an observer-rated scale that measures illness severity (CGIS). The CGIS is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through 7 (amongst the most severely ill patients).
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=226 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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Change in Tele-visit Clinician Global Impression - Severity (CGIS; Score)
BL to Month 12
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0.103 score on a scale
Interval 0.03 to 0.176
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Change in Tele-visit Clinician Global Impression - Severity (CGIS; Score)
BL to Month 24
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0.004 score on a scale
Interval -0.108 to 0.116
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SECONDARY outcome
Timeframe: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months)The Fox Insight PDQ-8 (Parkinson's Disease Questionnaire, short-form 8 item version) is a self-administered questionnaire used to measure quality of life in persons with Parkinson's disease. The response to each question is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Scores range from a minimum of 0 to a maximum of 32, with a higher score indicating a poorer quality of life.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=154 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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|---|---|
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 6
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0.637 score on a scale
Interval 0.273 to 1.0
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 9
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1.258 score on a scale
Interval 0.849 to 1.667
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 3
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0.396 score on a scale
Interval 0.016 to 0.775
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 12
|
1.113 score on a scale
Interval 0.719 to 1.508
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 15
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1.687 score on a scale
Interval 1.208 to 2.166
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 18
|
1.543 score on a scale
Interval 1.09 to 1.995
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 21
|
1.317 score on a scale
Interval 0.894 to 1.74
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Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
BL to Month 24
|
1.744 score on a scale
Interval 1.28 to 2.208
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SECONDARY outcome
Timeframe: Two years (0, 6, 12, 18, and 24 months)The Fox Insight EQ-5D (European Quality of life survey) is a standardized measure of health-related quality of life assessing five dimensions of health. It comprises five corresponding questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A derived summary index score is higher with better health-related quality of life. A maximum of 1 corresponds to the best quality of life, whereas a score of 0 is intended to approximate a state equivalent to death, with values less than 1 corresponding to a state worse than death.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=146 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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|---|---|
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Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)
BL to Month 6
|
-0.010 score on a scale
Interval -0.048 to 0.028
|
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Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)
BL to Month 12
|
-0.015 score on a scale
Interval -0.055 to 0.024
|
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Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)
BL to Month 18
|
0.003 score on a scale
Interval -0.043 to 0.048
|
|
Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)
BL to Month 24
|
-0.040 score on a scale
Interval -0.084 to 0.003
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SECONDARY outcome
Timeframe: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months)The Non-motor Symptoms Questionnaire (NMS-QUEST) is a 30-question self-reported assessment. Each question is of a yes/no format with a score of 1 given to each "yes" answer, with total scores ranging from 0-30, with higher scores indicating a greater number of non-motor symptoms. Participants completed the assessment online in Fox Insight.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=154 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
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|---|---|
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Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 3
|
0.447 score on a scale
Interval -0.043 to 0.938
|
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Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 6
|
1.062 score on a scale
Interval 0.567 to 1.557
|
|
Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 9
|
1.432 score on a scale
Interval 0.914 to 1.95
|
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Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 12
|
1.323 score on a scale
Interval 0.849 to 1.797
|
|
Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 15
|
1.642 score on a scale
Interval 1.122 to 2.163
|
|
Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 18
|
1.720 score on a scale
Interval 1.16 to 2.28
|
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Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 21
|
1.660 score on a scale
Interval 1.092 to 2.227
|
|
Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
BL to Month 24
|
2.046 score on a scale
Interval 1.505 to 2.588
|
SECONDARY outcome
Timeframe: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months)The Fox Insight Rapid Eye Movement Behavior Disorder (RBD) score is a patient-reported binary ("no" or "yes") response to a single question of whether they act out their dreams while asleep. Participants report their response online through the Fox Insight web-based platform. The score value is dichotomous (or missing) and ranges from 0 (no symptom) to 1 (yes response).
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=143 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
|
|---|---|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 3
|
-0.125 score on a scale
Interval -0.318 to 0.068
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 6
|
-0.008 score on a scale
Interval -0.128 to 0.111
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 9
|
0.020 score on a scale
Interval -0.177 to 0.217
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 12
|
0.088 score on a scale
Interval -0.124 to 0.3
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 15
|
-0.117 score on a scale
Interval -0.327 to 0.094
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 18
|
0.148 score on a scale
Interval 0.007 to 0.288
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 21
|
0.003 score on a scale
Interval -0.241 to 0.248
|
|
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
BL to Month 24
|
0.349 score on a scale
Interval 0.081 to 0.616
|
SECONDARY outcome
Timeframe: Two years (0, 3, 9, 15, and 21 months)The Parkinson's Daily Activities Questionnaire -15 (PDAQ-15) is a 15-item measure of activities of daily living (ADL) that are impacted by cognitive impairment in participants with Parkinson's disease. The PDAQ-15 is derived from the original 50-item scale and is completed by the participant in Fox Insight. Scores range from 0 to 60, with higher scores indicating better function.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=152 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
|
|---|---|
|
Change in Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; Score)
BL to Month 3
|
0.611 score on a scale
Interval -0.514 to 1.735
|
|
Change in Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; Score)
BL to Month 9
|
-0.798 score on a scale
Interval -2.218 to 0.621
|
|
Change in Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; Score)
BL to Month 15
|
-0.400 score on a scale
Interval -1.769 to 0.97
|
|
Change in Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; Score)
BL to Month 21
|
-1.618 score on a scale
Interval -3.105 to -0.13
|
SECONDARY outcome
Timeframe: Two years (0, 12, and 24 months)The Geriatric Depression Scale (GDS) is a measure of depression completed by the participant online in Fox Insight. The scale has 30 yes/no questions, with each question having a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score, the greater the depression.
Outcome measures
| Measure |
Former Phase 3 PD Trial Participants
n=144 Participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
|
|---|---|
|
Change in Fox Insight Geriatric Depression Scale (GDS; Score)
BL to Month 24
|
0.855 score on a scale
Interval -0.33 to 2.04
|
|
Change in Fox Insight Geriatric Depression Scale (GDS; Score)
BL to Month 12
|
0.401 score on a scale
Interval -0.581 to 1.382
|
Adverse Events
Former Phase 3 PD Trial Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Former Phase 3 PD Trial Participants
n=226 participants at risk
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.44%
1/226 • 2 years
|
Additional Information
Dr. Michael Schwarzschild
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place