Istradefylline for Parkinson Disease With Cognitive Impairment

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Kyowa Kirin, Inc.
• Treatments: Istradefylline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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