Recruiting
Phase 2

NeuroEXPLORER

Sponsor:

Michael J. Fox Foundation for Parkinson's Research

Code:

NCT07809438

Conditions

Prodromal Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F] AV-133 PET Imaging

Study Details

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

Study ID

NCT07809438

Start date

Sep 18, 2025

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Prodromal Parkinson's disease (PD)

Interventions

[18F] AV-133 PET Imaging

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.

Primary outcome measure

  • Comparison of tracer uptake between two camera using Standardized Uptake Value ratio [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Locations

Institute for Neurodegenerative Disorders

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Mackenzee George Clinical Research Coordinator II

475-318-8248mgeorge@xingimaging.com

Kristen Hagwell Clinical Research Nurse II, RN

475-318-8259khagwell@xingimaging.com

Principal Investigator:

Neha Prakash, MBBS

More Information

Sponsor

Michael J. Fox Foundation for Parkinson's Research

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael J. Fox Foundation for Parkinson's Research on 2026-09-09.