Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease. (NCT05182151) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease.
Stopped: recruitment issues
United States8 participantsStarted 2022-07-29
Plain-language summary
Apathy is defined as a lack of feeling, emotion, interest, or concern. Apathy also involves reduction or loss of motivation and goal-directed behavior. Clinically significant apathy, where meaningful activities are given up and quality of life is diminished, is common in people with Parkinson's disease (PD).
Many individuals with Parkinson's disease experiencing fluctuations in the severity of their movement problems and medication "off" time. "Off" time refers to periods of the day between doses of PD medication when your motor symptoms (e.g., tremor, stiffness, slowness, walking problems, etc.) are worse and interfere with your ability to complete tasks of daily living. The investigational drug, Istradefylline, is an FDA-approved medication to treat motor fluctuations and "off" time in PD.
The purpose of this study is to investigate whether people with Parkinson's disease (PD) who are treated with istradefylline (ISD) show improvements in motivation and apathy over a 12-week period. Specifically, we wish to see whether people with PD who are treated with ISD engage in more physical and recreational activities, such as hobbies and other interests.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of PD consistent with United Kingdom Brain Bank Criteria or the Movement Disorder Society Research Criteria for the Diagnosis of Parkinson's Disease, with bradykinesia and sequence effect being present, and prominent motor asymmetry (if no rest tremor).
. Current treatment with levodopa.
. Stable on levodopa and other study-approved medications for PD motor symptoms for at least four weeks prior to screening.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.