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| Name | Class |
|---|---|
| Kyowa Kirin, Inc. | INDUSTRY |
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The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care plus istradefylline | Experimental | Participants will receive usual care, and in addition, will be asked to take istradefylline daily for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Istradefylline medication | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in executive function - Card Sort test | 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 | Baseline to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurocognitive outcomes | 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. | Baseline to 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Barrett, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 3, 2026 | 9 | ||
| Jun 3, 2026 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Change in recall | 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. | Baseline to 26 weeks |
| Change in oral fluency | 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. | Baseline to 26 weeks |
| Change in executive function - Trail Making Test | 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. | Baseline to 26 weeks |
| Change in cognitive status | 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. | Baseline to 26 weeks |
| Change in higher cortical functions | 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 | Baseline to 26 weeks |
| Jun 26, 2026 |
| 10 |
| Jul 1, 2026 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |