Trial Radar AI
Clinical Trial NCT07348250 for Parkinson's Disease (PD), Parkinson's Disease, Parkinson's Disease (Disorder) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson's Disease Early Phase 1 22 Senior-Focused Open-Label

Recruiting
Clinical Trial NCT07348250 is designed to study Diagnostic for Parkinson's Disease (PD), Parkinson's Disease, Parkinson's Disease (Disorder). It is a Early Phase 1 interventional study that is recruiting, having started on December 8, 2025, with plans to enroll 22 participants. Led by Invicro, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on January 16, 2026.
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 buil...Show More
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 e...Show More
Official Title

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

Conditions
Parkinson's Disease (PD)Parkinson's DiseaseParkinson's Disease (Disorder)
Other Study IDs
  • MK-0947 PN001
NCT ID Number
NCT07348250
Start Date (Actual)
2025-12-08
Last Update Posted
2026-01-16
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
22
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
alpha-synuclein
α-synuclein
Neurodegeneration
MK-0947
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPart 1 - Brain Imaging
Participants receive \[18F\]MK-0947 for PET imaging of the brain.
[18F]MK-0947
PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.
ExperimentalPart 2 - Dosimetry
Healthy participants receive \[18F\]MK-0947 for whole-body dosimetry.
[18F]MK-0947
PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Brain uptake of [18F]MK-0947
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
Pharmacokinetic parameters of \[18F\]MK-0947 derived from dynamic PET imaging and plasma input functions.
Up to 36 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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
Invicro logoInvicro
Merck Sharp & Dohme LLC logoMerck Sharp & Dohme LLC
Study Central Contact
Contact: David Russell, MD, PhD, 203-401-4300, [email protected]
1 Study Locations in 1 Countries

Connecticut

Invicro (dba Perceptive), New Haven, Connecticut, 06510, United States
David Russell, M.D., Ph.D, Contact, 203-401-4300, [email protected]
Contact, [email protected]
Recruiting