Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)

NCT07265596 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PPMI 015
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 8

Brief Summary

The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).

Conditions

Prodromal Parkinsons Disease

Outcome Measures

Primary Outcomes (1)

• [18F]AV-133 mean rate of change and variability

  The mean rates of change and the variability around the mean of \[18F\]AV-133 PET SUVr in Prodromal PD patients, and where appropriate the comparison of these rates between patient subsets at study intervals ranging from 12 months to 24 months.

  24 months

Secondary Outcomes (6)

• [18F]AV-133 prediction of clinical motor progression

  24 months

• [18F]AV-133 prediction of clinical cognitive progression

  24 months

• [18F]AV133 cutoff for clinical PD

  24 months

• [18F] AV133 correlation with DaTscan

  24 months

• Correlation of [18F]AV133 change with change in clinical and biomarker outcomes

  24 months

Study Arms (1)

Prodromal Parkinson's disease (PD)

EXPERIMENTAL

Prodromal Parkinson's disease participants enrolled in the PPMI Clinical 002 study will receive 3 injections of \[18F\] AV-133 and imaging procedures over the course of 24 months.

Drug: [18F] AV-133 PET Imaging

Interventions

[18F] AV-133 PET Imaging DRUG

Prodromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with \[18F\]AV-133 under this protocol at baseline, 12-month and 24 months.

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:

• A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
• Able to provide informed consent.
• Male or Female (females must meet additional criteria specified below as applicable)
• Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of 18F-AV-133
• Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
• Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
• Females of childbearing potential must not be pregnant, breastfeeding or lactating.
• Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of PET scan.

You may not qualify if:

• Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.
• Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Sponsors & Collaborators

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

Study Sites (8)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

NOT YET RECRUITING

Philipps-University of Marburg

Hessen, 35043, Germany

NOT YET RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

NOT YET RECRUITING

Radboud University

Nijmegen, Gelderland, 6525 GC, Netherlands

NOT YET RECRUITING

Queen Mary University of London

London, Britain, EC1M 6BQ, United Kingdom

RECRUITING

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE45PL, United Kingdom

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: September 12, 2025
• First Posted: December 5, 2025
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

US (2); IL (1); DE (1); NL (1); GB (2); CA (1)