This Protocol is a Sub-study Under the PPMI Program. It is a Longitudinal, Single-center Study to Assess the Performance of [18F]AV-133 Imaging Using High and Standard Resolution PET in Individuals Enrolled With Parkinson's Disease (PD) for up to 12 Months.

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Michael J. Fox Foundation for Parkinson's Research
Study ID
NCT07830654
Phase
PHASE2
Status
Recruiting
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Conditions

  • Healthy Control Subjects
  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [18F]AV-133 — DRUG
    This protocol is a sub-study under the PPMI Program. It is a longitudinal, single-center study to assess the performance of \[18F\]AV-133 imaging using high and standard resolution PET in individuals enrolled with Parkinson's disease (PD) for up to 12 months.

Study Details

The study is a longitudinal, single-center study to assess progression of \[18F\]AV-133 imaging in PD participants. Participants will be followed for up to 12 months. Approximately 45 PD participants and 5 healthy control participants will be recruited from the ongoing PPMI Clinical 002 study. Participants will be comprehensively assessed at Baseline and follow up according to the Schedule of Activities. Participants will undergo PET imaging assessments with \[18F\]AV-133. After tracer injection, participants will be imaged on PET cameras at each imaging timepoint-one with the NX camera and one with a standard PET camera-in accordance with the Image Acquisition Protocol (IAP).

Key Dates

First listed
Sep 21, 2026
Start date
Sep 25, 2025
Status verified
Sep 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Parkinson's Disease & Healthy Controls

Primary Outcome Measure

Comparison of tracer uptake between two cameras using Standardized Uptake Value Ratio (SUVR) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Neurodegenerative DisordersNew HavenConnecticut06517
Kristen Hagwell, RN
[email protected]
475-318-8259
Mackenzee George
[email protected]
Neha Prakash, MBBS (PRINCIPAL_INVESTIGATOR)

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