Cognitive Impairment, Parkinson Disease
Conditions
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.
Interventions
DRUGIstradefylline 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
Sponsors
Kyowa Kirin, Inc.
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in executive function - Card Sort test | Baseline to 26 weeks | Executive function will be assessed using the Card Sort Test from the NIH Toolbox Cognition Battery. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in recall | Baseline to 26 weeks | Immediate and delayed recall will be assessed using the Hopkins Verbal Learning Test - Revised, which will be administered by a trained clinician. Higher scores indicate better recall. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks. |
| Change in oral fluency | Baseline to 26 weeks | In the Controlled Oral Word Association Test (FAS, animals) (COWAT) the participant is asked to make verbal associations to different letters of the alphabet by saying all the words which they can think of beginning with a given letter. Higher scores indicate better oral fluency. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks. |
| Change in neurocognitive outcomes | Baseline to 26 weeks | NIH Toolbox Cognition Battery (NTCB) consists of multiple self-report and clinician reported tests. The assessments can be completed on a tablet device and a composite as well as sub-scores are calculated. Higher scores are indicative of better functioning. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks. |
| Change in cognitive status | Baseline to 26 weeks | Participant's cognitive status will be assessed using the Montreal Cognitive Assessment score. Higher scores indicated better cognitive status. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks. |
| Change in higher cortical functions | Baseline to 26 weeks | The Dementia Rating Scale-2 (DRS-2) measures deficits in a large range of higher cortical functions and differentiates deficits of varying severity levels. The DRS-2 yields five subscales as well as an overall cognitive functioning score. Higher scores higher impairment. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks |
| Change in executive function - Trail Making Test | Baseline to 26 weeks | Participants will complete the Trail Making Test (TMT) which is a timed test of executive function. Scores are the number of seconds needed to complete the test with higher scores indicate poorer executive function. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks. |
Countries
United States
Outcome results
None listed