Status:
ACTIVE_NOT_RECRUITING
Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™
Lead Sponsor:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Brief Summary
Directly examine whether early (6-month) imaging with DaTscan and \[¹⁸F\] AV-133 will provide an early signal of disease progression in recently diagnosed untreated PD patients.
Detailed Description
The study is a longitudinal, multi-center study to assess progression of DaTscan and \[18F\] AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24 months. Approximate...
Eligibility Criteria
Inclusion
- A PD participant consented to PPMI Clinical, or, a Prodromal participant confirmed eligible to proceed to PPMI Clinical Baseline visit.
- Able to provide informed consent.
- Women may not be pregnant, lactating or planning pregnancy during the study.
- Includes a negative serum pregnancy test prior to Baseline 18F-AV-133 injection.
- Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of Baseline PET scan.
- Women participating in the study must be of non-childbearing potential or be using a highly effective method of birth control 14 days prior to until at least 24 hours after the last 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 Screening) 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.
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.
- Have current clinically significant cardiovascular disease or abnormalities on screening ECG (including but not limited to QTc \> 450 msec).
- Are currently taking medications that are known to cause QT- prolongation
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Key Trial Info
Start Date :
September 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04507139
Start Date
September 10 2020
End Date
June 1 2025
Last Update
October 31 2024
Active Locations (3)
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1
Institute For Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
2
Boston University Medical Center
Boston, Massachusetts, United States, 02118
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107