ClinicalTrials.gg
RecruitingNCT07830654Updated Sep 21, 2026

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.

A Phase 2 interventional study of [18F]AV-133 in Parkinson's Disease (PD) and Healthy Control Subjects, sponsored by Michael J. Fox Foundation for Parkinson's Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Michael J. Fox Foundation for Parkinson's Research · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2025, registered Sep 2026).
  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

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

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03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Able to provide .
  3. Male or Female (females must meet additional criteria specified below as applicable)

    1. Females must be of non- or using a highly effective method of 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 (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.
    2. 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

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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Parkinson's Disease & Healthy Controls

    Drug: [18F]AV-133

Interventions

  • 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.

06

What researchers measure

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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07830654
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Sep 25, 2025
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Lianne Ramia
Contact
LRamia1@indd.org
203-590-5600
Jessica Dimos
Contact
jdimos@indd.org
203-590-5600
Ken Marek, MD
principal investigator · Institute for Neurodegenerative Disorders

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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