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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInvicro

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

  • [18F]MK-0947

    Drug

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

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Part 1 - Brain ImagingExperimental treatment 1 intervention
Group B: Part 2 - DosimetryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Incidence of adverse events (AEs) following administration

Time frame
Up to 4 months
2

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

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

Time frame
4 months

Secondary outcomes

1

Brain uptake of [18F]MK-0947

Quantitative assessment of \[18F\]MK-0947 uptake in brain regions measured by PET imaging.

Time frame
Up to 36 days
2

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

Pharmacokinetic parameters of \[18F\]MK-0947 derived from dynamic PET imaging and plasma input functions.

Time frame
Up to 36 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Invicro

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator