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

NCT07348250 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

[18F]MK-0947

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348250 on ClinicalTrials.gov