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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Invicro
Study ID
NCT07348250
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • [18F]MK-0947 — DRUG
    PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part 1 - Brain Imaging
    Participants receive \[18F\]MK-0947 for PET imaging of the brain.
  • Experimental: Part 2 - Dosimetry
    Healthy participants receive \[18F\]MK-0947 for whole-body dosimetry.

Primary Outcome Measure

Safety of [18F]MK-0947: Incidence of Adverse Events [ Time Frame: Up to 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Invicro (dba Perceptive)New HavenConnecticut06510
David Russell, M.D., Ph.D
[email protected]
203-401-4300
[email protected]

Find similar trials in New Haven, CT

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Invicro (dba Perceptive)· New Haven, CT

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