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NCT07348250TerminatedEarly phase 1

Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson's Disease

An Open-label Study to Evaluate Brain α-Synuclein Deposition Using Positron Emission Tomography (PET) and [18F]MK-0947 in Patients With Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 27 Jul 2026

Reason given: Study terminated due to site closure.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
16 (actual)
First submitted
29 Dec 2025
Start date
8 Dec 2025
Primary completion date
26 Mar 2026
Lead sponsor
Invicro
NCT number
NCT07348250

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to PET or MRI procedures (e.g., implants, claustrophobia)
  • Current or prior participation in investigational drug study within 30 days

Other illness

  • Clinically significant hepatic, renal, cardiovascular, pulmonary, or systemic illness
  • History of severe allergic reactions to PET tracers or related compounds
  • Any condition that may interfere with study conduct or participant safety

Other

  • Unwilling or unable to provide informed consent
  • Pregnant or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Invicro (dba Perceptive)New HavenUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.