NCT07809438 A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease
| NCT ID | NCT07809438 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Michael J. Fox Foundation for Parkinson's Research |
| Condition | Prodromal Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-09-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2025-09-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study \[PPMI 015\] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the \[18F\]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol. This study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data. All participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.
Eligibility Criteria
Inclusion Criteria: 1. Prodromal participant enrolled in the PPMI 015 sub study. 2. Able to provide consent. Exclusion Criteria: a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
Contact & Investigator
Ken Marek, MD
PRINCIPAL INVESTIGATOR
Institute for Neurodegenerative Disorders
Frequently Asked Questions
Who can join the NCT07809438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prodromal Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07809438 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07809438 currently recruiting?
Yes, NCT07809438 is actively recruiting participants. Contact the research team at LRamia1@indd.org for enrollment information.
Where is the NCT07809438 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07809438 clinical trial?
NCT07809438 is sponsored by Michael J. Fox Foundation for Parkinson's Research. The principal investigator is Ken Marek, MD at Institute for Neurodegenerative Disorders. The trial plans to enroll 25 participants.
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