Clinical trial NCT05333549: Istradefylline for Parkinson Disease With Cognitive Impairment
Official title: Istradefylline for Parkinson Disease Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Cognitive Impairment
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Kyowa Kirin, Inc.
First posted: 2022-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in executive function - Card Sort test
timeFrame: Baseline to 26 weeks
Secondary outcomes:
measure: Change in neurocognitive outcomes
timeFrame: Baseline to 26 weeks
measure: Change in recall
timeFrame: Baseline to 26 weeks
measure: Change in oral fluency
timeFrame: Baseline to 26 weeks
measure: Change in executive function - Trail Making Test
timeFrame: Baseline to 26 weeks
measure: Change in cognitive status
timeFrame: Baseline to 26 weeks
measure: Change in higher cortical functions
timeFrame: Baseline to 26 weeks
measure: Change in clinical symptoms related to Parkinson disease
timeFrame: Baseline to 26 weeks
measure: Change in Parkinson disease stage
timeFrame: Baseline to 26 weeks
measure: Change in Schwab and England ADL score
timeFrame: Baseline to 26 weeks
measure: Change in hours of "off" time
timeFrame: Baseline to 26 weeks
measure: Change in percentage of "off" time
timeFrame: Baseline to 26 weeks
measure: Change in hours of "on" time
timeFrame: Baseline to 26 weeks
measure: Change in percentage of "on" time
timeFrame: Baseline to 26 weeks
measure: Change in severity of illness
timeFrame: Baseline to 26 weeks
measure: Change in Parkinson's health status
timeFrame: Baseline to 26 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Matthew Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References: