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NCT Number: NCT07830654

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.

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06517, United States

Location status: Recruiting

Location contact

Kristen Hagwell, RN

CONTACT

[email protected]

475-318-8259

Mackenzee George

CONTACT

[email protected]

Neha Prakash, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

[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.

Primary outcomes

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

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Dimos

CONTACT

[email protected]

203-590-5600

Lianne Ramia

CONTACT

[email protected]

203-590-5600

Sponsors and collaborators

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Other

Registry information

Official study title

A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F]AV- 133 in Parkinson's Disease [Dual PET AV-133 in PD]

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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