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.

NCT07830654 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PPMI 033
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Parkinson's Disease (PD); Healthy Control Subjects

Outcome Measures

Primary Outcomes (1)

• Comparison of tracer uptake between two cameras using Standardized Uptake Value Ratio (SUVR)

  To compare longitudinal change in \[18F\]AV-133 PET SUVR in the striatum and other brain regions acquired with NeuroEXPLORER (NX) camera to that acquired with Siemens Biograph camera.

  12 months

Study Arms (1)

Parkinson's Disease & Healthy Controls

EXPERIMENTAL

Drug: [18F]AV-133

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.

Parkinson's Disease & Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants over the age of 18 who are enrolled in the PPMI Clinical protocol with a diagnosis of Parkinson's disease (PD) or Healthy Control participants enrolled in the PPMI Clinical protocol.
• 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 (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06517, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

florbenazine F 18

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

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 15, 2026
• First Posted: September 21, 2026
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)