Istradefylline for Parkinson Disease With Cognitive Impairment

NCT ID: NCT05333549

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2025-06-09

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 is called on-time. Once the medication stops working, a so called "off" episode starts, where symptoms recur. Usual care for treatment of Parkinson disease with cognitive impairment is use of cognition enhancing medications also called cholinesterase inhibitors. In this study, participants will receive usual care, and in addition, they will be asked to take istradefylline daily for 26 weeks.

Conditions

Parkinson Disease; Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual care plus istradefylline

Participants will receive usual care, and in addition, will be asked to take istradefylline daily for 26 weeks.

Group Type: EXPERIMENTAL

Istradefylline medication

Intervention Type: DRUG

2 weeks on istradefylline 20mg daily, 2 weeks on istradefylline 40mg with the ability to adjust other antiparkinsonian medications, and 22 weeks on istradefylline 40mg and stable antiparkinsonian medications

Interventions

Istradefylline medication

2 weeks on istradefylline 20mg daily, 2 weeks on istradefylline 40mg with the ability to adjust other antiparkinsonian medications, and 22 weeks on istradefylline 40mg and stable antiparkinsonian medications

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin, Inc.

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20022119

Identifier Type: -

Identifier Source: org_study_id