Istradefylline for Parkinson Disease With Cognitive Impairment

Last updated: July 22, 2025
Sponsor: Virginia Commonwealth University
Overall Status: Completed

Phase

2

Condition

Memory Loss

Mental Disability

Mild Cognitive Impairment

Treatment

Istradefylline

Istradefylline medication

Clinical Study ID

NCT05333549
HM20022119
  • Ages > 50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet criteria for probable Parkinson disease dementia or PD-MCI (mild cognitiveimpairment)

  • 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

Exclusion Criteria:

  • Meet criteria for dementia with Lewy bodies, including dementia onset prior to orwithin 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

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Istradefylline
Phase: 2
Study Start date:
July 18, 2022
Estimated Completion Date:
June 09, 2025

Study 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.

Connect with a study center

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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