Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson… (NCT07348250) | Clinical Trial Compass
RecruitingEarly Phase 1
Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson's Disease
United States22 participantsStarted 2025-12-08
Plain-language summary
This clinical study is being conducted to learn more about a new imaging drug called \[18F\]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders.
The main goal of this study is to find out if \[18F\]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time.
Who can join? Adults who have PD or who are healthy may be able to take part. Participants will have screening tests to make sure they qualify.
What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants.
Why is this important? There is currently no cure for PD, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PD and similar conditions in the future.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent prior to any study procedures
* Women of childbearing potential: abstinent or use 2 contraception methods (one barrier) during study and 90 days post last injection
* Men: use 2 contraception methods and refrain from sperm donation during study and 90 days post last injection
* PD \& HE participants: Age 40-80 years; HP participants: Age 18-50 years
* Adequate circulation and normal clotting for arterial cannulation (if applicable)
* HE participants: no neurological disorder, no first-degree relative with idiopathic PD
* HP participants: healthy with no clinically relevant findings
Exclusion Criteria:
* Unwilling or unable to provide informed consent
* Clinically significant hepatic, renal, cardiovascular, pulmonary, or systemic illness
* Pregnant or breastfeeding
* Contraindication to PET or MRI procedures (e.g., implants, claustrophobia)
* History of severe allergic reactions to PET tracers or related compounds
* Current or prior participation in investigational drug study within 30 days
* Any condition that may interfere with study conduct or participant safety
Questions worth asking your doctor
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.
What they're measuring
1
Safety of [18F]MK-0947: Incidence of Adverse Events
Timeframe: Up to 4 months
2
Safety of [18F]MK-0947: Radiation absorbed dose estimates