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

January 9, 2026 updated by: Invicro

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This Phase 1, open-label study will evaluate the safety, pharmacokinetics, and imaging characteristics of [18F]MK-0947, a novel PET tracer targeting α-synuclein pathology in Parkinson's disease (PD). The study consists of two parts: Part 1 includes PD and healthy elderly participants for brain imaging using standard and high-resolution PET scanners; Part 2 includes healthy participants for whole-body dosimetry to estimate radiation exposure. Imaging sessions will involve dynamic PET scans lasting up to 2 hours, arterial or venous blood sampling for kinetic modeling, and MRI for anatomical co-registration. Safety assessments include vital signs, ECGs, laboratory tests, and adverse event monitoring. The investigational tracer will be administered intravenously at doses up to 10 mCi, with strict adherence to radiation safety guidelines. Data will be analyzed using compartmental and graphical modeling approaches to derive quantitative metrics such as SUV, SUVR, VT, and DVR. This study aims to establish proof of concept for [18F]MK-0947 as a biomarker for α-synuclein pathology, supporting future therapeutic trials and advancing diagnostic capabilities for synucleinopathies.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 - Brain Imaging
Participants receive [18F]MK-0947 for PET imaging of the brain.
Drug: [18F]MK-0947
PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.
Other Names:
  • MK-0947
Experimental: Part 2 - Dosimetry
Healthy participants receive [18F]MK-0947 for whole-body dosimetry.
Drug: [18F]MK-0947
PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.
Other Names:
  • MK-0947

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of [18F]MK-0947: Incidence of Adverse Events
Time Frame: Up to 4 months
Incidence of adverse events (AEs) following administration
Up to 4 months
Safety of [18F]MK-0947: Radiation absorbed dose estimates
Time Frame: 4 months
Radiation absorbed dose estimates following administration derived from PET imaging and dosimetry calculations.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain uptake of [18F]MK-0947
Time Frame: Up to 36 days
Quantitative assessment of [18F]MK-0947 uptake in brain regions measured by PET imaging.
Up to 36 days
Model-derived Pharmacokinetics of [18F]MK-0947
Time Frame: Up to 36 days
Pharmacokinetic parameters of [18F]MK-0947 derived from dynamic PET imaging and plasma input functions.
Up to 36 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invicro

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK-0947 PN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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