Trial Outcomes & Findings for Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease (NCT NCT06192823)
NCT ID: NCT06192823
Last Updated: 2026-05-08
Results Overview
The Parkinson's Disease-Related Pattern (PDRP) is a disease-specific metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects Parkinson's disease-related abnormalities in regional cerebral glucose metabolism. Individual PDRP scores represent standardized network expression values (z-scores; A Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
COMPLETED
20 participants
Day 1 and Day 8
2026-05-08
Participant Flow
Participant milestones
| Measure |
Early-Stage PD
Participants with early-stage Parkinson's disease underwent a one-week supervised dopaminergic medication washout. Assessments included FDG-PET imaging on Day 1 (ON medications) and Day 8 (after washout), as well as daily wearable sensor measurements using the Kinesia ONE system to quantify motor performance (finger tapping bradykinesia and tremor) alongside standard motor and cognitive testing. Safety monitoring and adverse event assessments were performed throughout the washout period.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Early-Stage PD
Participants with early-stage Parkinson's disease underwent a one-week supervised dopaminergic medication washout. Assessments included FDG-PET imaging on Day 1 (ON medications) and Day 8 (after washout), as well as daily wearable sensor measurements using the Kinesia ONE system to quantify motor performance (finger tapping bradykinesia and tremor) alongside standard motor and cognitive testing. Safety monitoring and adverse event assessments were performed throughout the washout period.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Early-Stage PD
n=20 Participants
patients with early-stage PD as defined by inclusion/exclusion criteria
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=41 Participants
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Age, Categorical
>=65 years
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11 Participants
n=41 Participants
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Age, Continuous
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65.7 years
STANDARD_DEVIATION 6.7 • n=41 Participants
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Sex: Female, Male
Female
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5 Participants
n=41 Participants
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Sex: Female, Male
Male
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15 Participants
n=41 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=41 Participants
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Race (NIH/OMB)
White
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20 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
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Region of Enrollment
United States
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20 participants
n=41 Participants
|
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PD medication (years)
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1.7 years
STANDARD_DEVIATION 0.8 • n=41 Participants
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Unified Parkinson's Disease Rating Scale (UPDRS) Part-III overnight OFF medication at screening
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28.3 units on a scale
STANDARD_DEVIATION 6.5 • n=41 Participants
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UPDRS-III ON medication at screening
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12.3 units on a scale
STANDARD_DEVIATION 6.3 • n=41 Participants
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Unified Parkinson's Disease Rating Scale, Part III improvement ON medication (%) at screening
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59 percentage change
STANDARD_DEVIATION 15 • n=41 Participants
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Levodopa Equivalent Daily Dose (LEDD)
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490 mg/day
STANDARD_DEVIATION 414 • n=41 Participants
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PRIMARY outcome
Timeframe: Day 1 and Day 8Population: One participant withdrew and did not have OFF data collected
The Parkinson's Disease-Related Pattern (PDRP) is a disease-specific metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects Parkinson's disease-related abnormalities in regional cerebral glucose metabolism. Individual PDRP scores represent standardized network expression values (z-scores; A Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
Outcome measures
| Measure |
Early-Stage PD
n=19 Participants
Early-Stage PD Cohort
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|---|---|
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Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications
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-0.6 Z score
Standard Deviation 1.54
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PRIMARY outcome
Timeframe: Day 1 and Day 8Population: One participant withdrew and did not have OFF data collected
The Parkinson's Disease Cognitive Pattern (PDCP) is a disease-related metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects metabolic abnormalities associated with cognitive dysfunction in Parkinson's disease. PDCP scores represent standardized network expression values (z-scores; Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease cognitive metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
Outcome measures
| Measure |
Early-Stage PD
n=19 Participants
Early-Stage PD Cohort
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|---|---|
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Changes in the Parkinson's Disease Cognitive Pattern (PDCP) Z-Score From ON Medications to One-week OFF Medications
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0.12 Z-score
Standard Deviation 0.92
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PRIMARY outcome
Timeframe: Day 1 through Day 8Population: One participant withdrew and did not have OFF data collected
Finger tapping speed was measured using the Kinesia ONE wearable motion sensor system during standardized finger tapping tasks. Accelerometer data were used to generate quantitative finger tapping speed scores reflecting bradykinesia severity. Left and right finger tapping scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater bradykinesia severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.
Outcome measures
| Measure |
Early-Stage PD
n=19 Participants
Early-Stage PD Cohort
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|---|---|
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 1
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0.99 units on a scale
Standard Deviation 0.66
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 2
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1.04 units on a scale
Standard Deviation 0.54
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 3
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1.18 units on a scale
Standard Deviation 0.52
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 4
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1.24 units on a scale
Standard Deviation 0.58
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 5
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1.38 units on a scale
Standard Deviation 0.59
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 6
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1.36 units on a scale
Standard Deviation 0.55
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 7
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1.47 units on a scale
Standard Deviation 0.49
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Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger Tapping Speed Day 8
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1.33 units on a scale
Standard Deviation 0.56
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PRIMARY outcome
Timeframe: 1 weekPopulation: One participant withdrew and did not have OFF data collected
Rest tremor severity was measured using the Kinesia ONE wearable motion sensor system during standardized tremor assessments. Accelerometer data were used to generate quantitative tremor severity scores. Left and right tremor scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater tremor severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.
Outcome measures
| Measure |
Early-Stage PD
n=19 Participants
Early-Stage PD Cohort
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|---|---|
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 1
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0.32 units on a scale
Standard Deviation 0.43
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 2
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0.35 units on a scale
Standard Deviation 0.46
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 3
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0.40 units on a scale
Standard Deviation 0.62
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 4
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0.53 units on a scale
Standard Deviation 0.83
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 5
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0.49 units on a scale
Standard Deviation 0.70
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 6
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0.45 units on a scale
Standard Deviation 0.71
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 7
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0.56 units on a scale
Standard Deviation 0.76
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Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Kinesia One Rest Tremor Day 8
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0.41 units on a scale
Standard Deviation 0.40
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PRIMARY outcome
Timeframe: 1 weekPopulation: 1 participant discontinued the washout on day 5 due to parkinsonian symptoms
Number of participants experiencing an adverse event judged by the study neurologist to be related to the dopaminergic medication washout during the study period.
Outcome measures
| Measure |
Early-Stage PD
n=20 Participants
Early-Stage PD Cohort
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|---|---|
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Number of Participants With Adverse Events Related to the Medication Washout
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1 participants
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Adverse Events
Early-Stage PD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Early-Stage PD
n=20 participants at risk
Early-Stage PD Cohort
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|---|---|
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Nervous system disorders
Worsening parkinsonian symptoms during medication washout
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5.0%
1/20 • Number of events 1 • 1 week
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place