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 — DRUG
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Neurodegenerative DisordersNew HavenConnecticut06510
Mackenzee George Clinical Research Coordinator II
475-318-8248
Kristen Hagwell Clinical Research Nurse II, RN
475-318-8259
Neha Prakash, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT