Status:
COMPLETED
Istradefylline for Parkinson Disease With Cognitive Impairment
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Kyowa Kirin, Inc.
Conditions:
Parkinson Disease
Cognitive Impairment
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.
Detailed Description
Istradefylline has been approved by the U. S. Food and Drug Administration (FDA) to reduce "off" episodes in Parkinson disease. The period when levodopa has a positive effect on Parkinson's symptoms i...
Eligibility Criteria
Inclusion
- Meet criteria for probable Parkinson disease dementia or PD-MCI (mild cognitive impairment)
- Age greater than 50
- Hoehn and Yahr stage \< 4 in "on" state
- Currently taking carbidopa/levodopa
- Antiparkinsonian medications stable for at least 4 weeks prior to baseline visit
- Cholinesterase inhibitor dose stable for 8 weeks prior to baseline visit
Exclusion
- Meet criteria for dementia with Lewy bodies, including dementia onset prior to or within 1 year of parkinsonism onset
- Presence of troublesome dyskinesias
- Pregnancy or possibility of becoming pregnant during the study period.
- Moderate or severe hepatic impairment
- dementia too severe to complete study measures or to adhere to medication schedule
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05333549
Start Date
July 18 2022
End Date
June 9 2025
Last Update
July 28 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298