Recruiting
Phase 2

AV-133

Sponsor:

Michael J. Fox Foundation for Parkinson's Research

Code:

NCT07265596

Conditions

Prodromal Parkinsons Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F] AV-133 PET Imaging

Study Details

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

Study ID

NCT07265596

Start date

Oct 30, 2023

Status verified date

Nov, 2025

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. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
2. Able to provide informed consent.
3. 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.

Exclusion Criteria:

1. 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.
2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Prodromal Parkinson's disease (PD)

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.

Interventions

[18F] AV-133 PET Imaging

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.

Primary outcome measure

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

Amy Ruimerman Lead Clinical Research Nurse, LPN

475-318-8208aruimerman@xingimaging.com

Principal Investigator:

Neha Prakash, MBBS

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

PPMI Call Center

877-525-7764

Principal Investigator:

Nabila Dahodwala, MD

More Information

Sponsor

Michael J. Fox Foundation for Parkinson's Research

Last update posted

Dec 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Michael J. Fox Foundation for Parkinson's Research on 2025-12-05.