Istradefylline for Parkinson Disease With Cognitive Impairment

Virginia Commonwealth University (VCU)

Status and phase

Completed

Phase 2

Conditions

Cognitive Impairment

Parkinson Disease

Treatments

Drug: Istradefylline medication

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05333549

HM20022119

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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