Status:
RECRUITING
Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)
Lead Sponsor:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Prodromal Parkinsons Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Prodr...
Detailed Description
The Parkinson's Progression Marker Initiative (PPMI) is an observational, international, multi-center study designed to identify PD progression biomarkers both to improve understanding of disease etio...
Eligibility Criteria
Inclusion
- A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
- 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
- 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.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07265596
Start Date
October 30 2023
End Date
December 1 2027
Last Update
December 5 2025
Active Locations (8)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
3
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
4
Philipps-University of Marburg
Hessen, Germany, 35043