Michael J. Fox Foundation for Parkinson's Research
Phase
Phase 2
Started
2023-10-30
Last updated
2025-12-05
Condition(s) studied
Prodromal Parkinsons Disease
Investigational drug(s) / intervention(s)
[18F] AV-133 PET Imaging
[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.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
[18F]AV-133 mean rate of change and variability — 24 months 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.
Trial sites (8)
Facility
City
Region
Status
Institute for Neurodegenerative Disorders
New Haven
Connecticut
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Toronto Western Hospital
Toronto
Ontario
Not Yet Recruiting
Philipps-University of Marburg
Hessen
Germany
Not Yet Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Israel
Not Yet Recruiting
Radboud University
Nijmegen
Gelderland
Not Yet Recruiting
Queen Mary University of London
London
Britain
Recruiting
Newcastle University
Newcastle upon Tyne
Tyne and Wear
Recruiting
More Michael J. Fox Foundation for Parkinson's Research trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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