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Parkinson's drug istradefylline put to the test for thinking problems

NCT ID NCT05333549

Symptom relief Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time

Summary

Researchers at Virginia Commonwealth University are testing whether istradefylline, a drug already approved for Parkinson's disease movement symptoms, can improve cognition in people who have Parkinson's disease with mild cognitive impairment or dementia. The trial enrolls 15 adults over 50 who take carbidopa/levodopa and have stable antiparkinsonian medications. Participants take istradefylline for 26 weeks, starting at 20 mg daily and increasing to 40 mg, while researchers measure changes in executive function and other cognitive skills using the NIH Toolbox Cognition Battery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Istradefylline, an oral medication approved for Parkinson's disease that blocks adenosine A2A receptors
What this could lead to
If it works, istradefylline could become a new option for easing thinking problems in Parkinson's disease, an area with few effective treatments.
What could go wrong
This is a small Phase 2 trial with only 15 participants, so any cognitive benefit may not hold up in larger studies. Istradefylline can cause side effects like dyskinesia or nausea, and it may not improve thinking at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

15 people

The number who actually took part.

Started

Jul 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment Parkinson disease

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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