A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease

NCT07809438 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PPMI 030
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Prodromal Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Comparison of tracer uptake between two camera using Standardized Uptake Value ratio

  To compare \[18F\]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants

  Up to 24 months

Secondary Outcomes (4)

• Longitudinal comparison of quantitative signals (SUVR) between two PET cameras

  24 months

• Correlation of AV133 longitudinal change to clinical motor change

  24 months

• Correlation of AV133 longitudinal change to clinical cognitive change

  24 months

• Correlation of AV133 Longitudinal change to CSF biomarker

  24 months

Study Arms (1)

Prodromal Parkinson's disease (PD)

EXPERIMENTAL

Drug: [18F] AV-133 PET Imaging

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.

Prodromal Parkinson's disease (PD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prodromal participant enrolled in the PPMI 015 sub study.
• Able to provide consent.

You may not qualify if:

• a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

RECRUITING

Study Officials

• Ken Marek, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianne Ramia

CONTACT

203-590-5600; LRamia1@indd.org

Jessica Dimos

CONTACT

203-590-5600; jdimos@indd.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: September 9, 2026
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)