Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinso… (NCT06192823) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease
United States20 participantsStarted 2022-03-22
Plain-language summary
This study will evaluate the feasibility of adding objective measures (FDG-PET imaging, wearable biosensors) to a week-long washout protocol in early-stage Parkinson's disease patients. This study is also determining whether the washout can be conducted in the ambulatory setting.
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion criteria
✓. \*A clinical diagnosis of idiopathic PD. The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
✓. Clear and dramatic beneficial response to dopaminergic therapy (defined as demonstrating at least 30% improvement in parkinsonian motor signs based upon the UPDRS-III motor examination subscore, following the administration of their dopaminergic medications during the screening neurological examination)
✓. \*Hoehn and Yahr (H\&Y) stage II when off medication.
✓. Age between 50 and 75 years.
✓. Subjects must be on dopaminergic therapy for at least one year prior to the screening visit and less than four years prior to the completion of the washout period.
✓. Subjects must have a stable response to dopaminergic medication.
✓. Available for follow-up for the entire duration of the study.
✓. Subjects receiving antidepressant medication used specifically for the treatment of depression must be on stable doses for at least eight weeks prior to enrolling in the study.
Exclusion criteria
✕. \*Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
✕. Features unusual early in the clinical course (e.g., prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset)
What they're measuring
1
Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications
Timeframe: Day 1 and Day 8
2
Changes in the Parkinson's Disease Cognitive Pattern (PDCP) Z-Score From ON Medications to One-week OFF Medications
Timeframe: Day 1 and Day 8
3
Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Timeframe: Day 1 through Day 8
4
Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Timeframe: 1 week
5
Number of Participants With Adverse Events Related to the Medication Washout