A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Study ID
- NCT07809438
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Prodromal Parkinson's Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- [18F] AV-133 PET Imaging — DRUGThe study will compare the performance of \[18F\]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015.
Study Details
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.
Key Dates
- First listed
- Sep 9, 2026
- Start date
- Sep 18, 2025
- Status verified
- Sep 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Prodromal Parkinson's disease (PD)
Primary Outcome Measure
Comparison of tracer uptake between two camera using Standardized Uptake Value ratio [ Time Frame: Up to 24 months ]
Central Contacts
- Lianne Ramia203-590-5600
- Jessica Dimos203-590-5600
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | Neha Prakash, MBBS (PRINCIPAL_INVESTIGATOR) |