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

NCT07348250 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: MK-0947 PN001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson's Disease (PD); Parkinson's Disease; Parkinson's Disease (Disorder)

Keywords

alpha-synuclein; α-synuclein; Neurodegeneration; MK-0947

Outcome Measures

Primary Outcomes (2)

• Safety of [18F]MK-0947: Incidence of Adverse Events

  Incidence of adverse events (AEs) following administration

  Up to 4 months

• Safety of [18F]MK-0947: Radiation absorbed dose estimates

  Radiation absorbed dose estimates following administration derived from PET imaging and dosimetry calculations.

  4 months

Secondary Outcomes (2)

• Brain uptake of [18F]MK-0947

  Up to 36 days

• Model-derived Pharmacokinetics of [18F]MK-0947

  Up to 36 days

Study Arms (2)

Part 1 - Brain Imaging

EXPERIMENTAL

Participants receive \[18F\]MK-0947 for PET imaging of the brain.

Drug: [18F]MK-0947

Part 2 - Dosimetry

EXPERIMENTAL

Healthy participants receive \[18F\]MK-0947 for whole-body dosimetry.

Drug: [18F]MK-0947

Interventions

[18F]MK-0947 DRUG

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

Also known as: MK-0947

Part 1 - Brain Imaging; Part 2 - Dosimetry

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Invicro: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Invicro (dba Perceptive)

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David Russell, MD, PhD

CONTACT

203-401-4300; learnmore@perceptive.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 16, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)