Brain imaging of α-synuclein with [18F]MK-0947 PET in Parkinson's disease
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 trial will try a new PET imaging drug, [18F]MK-0947, to see if it can show α-synuclein buildup in the brains of adults with Parkinson's disease and healthy volunteers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Invicro Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07348250 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label trial gives adults with Parkinson's disease and healthy participants an intravenous dose of the PET tracer [18F]MK-0947 and performs dynamic PET scans (up to two hours) with MRI for anatomical co-registration. Arterial or venous blood samples will be collected for kinetic modeling, and a second part of the study enrolls healthy volunteers for whole-body dosimetry to estimate radiation exposure. Safety is monitored via vital signs, ECGs, laboratory tests, and adverse event reporting. Imaging data will be analyzed using compartmental and graphical models to derive quantitative metrics such as SUV, SUVR, VT, and DVR to determine whether the tracer highlights α-synuclein pathology.
Who should consider this trial
Good fit: Adults with diagnosed Parkinson's disease aged 40–80 and healthy volunteers (ages 40–80 for elderly controls and 18–50 for whole-body dosimetry) who can undergo PET/MRI scans, blood sampling, and comply with radiation-safety requirements are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have uncontrolled major medical issues, contraindications to MRI or PET (such as incompatible implants or severe claustrophobia), or a history of severe allergic reactions to PET tracers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the tracer could enable earlier and more accurate detection and tracking of α-synuclein in the brain, improving diagnosis and monitoring of Parkinson's disease.
How similar studies have performed: Human α-synuclein PET imaging is largely experimental with limited prior success, so this work represents early proof-of-concept rather than an established diagnostic approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut
- Invicro (dba Perceptive) — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: David Russell, MD, PhD
- Email: learnmore@perceptive.com
- Phone: 203-401-4300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.