RecruitingEarly Phase 1NCT07348250

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


Sponsor

Invicro

Enrollment

22 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is using a specialized brain scan (PET scan) with an experimental tracer called [18F]MK-0947 to measure deposits of a protein called alpha-synuclein in the brains of people with Parkinson's disease. Alpha-synuclein builds up in brain cells in Parkinson's and contributes to the disease. Researchers hope this scan can be used to track disease progression and test future treatments. **You may be eligible if...** - You have Parkinson's disease or are a healthy volunteer (age 40–80 for PD/healthy elderly; age 18–50 for healthy young participants) - You can provide informed consent - You do not have a neurological disorder (healthy participants) **You may NOT be eligible if...** - You have significant heart, kidney, liver, or lung disease - You are pregnant or breastfeeding - You have a metal implant, pacemaker, or claustrophobia that prevents PET/MRI scans - You have had a severe allergic reaction to PET scan tracers - You participated in another investigational drug study within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]MK-0947

PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.


Locations(1)

Invicro (dba Perceptive)

New Haven, Connecticut, United States

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NCT07348250


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