Status:
COMPLETED
PPMI Tau PET Imaging
Lead Sponsor:
Michael J. Fox Foundation for Parkinson's Research
Collaborating Sponsors:
Institute for Neurodegenerative Disorders
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-100 years
Phase:
PHASE2
Brief Summary
The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) will evaluate if \[18F\] PI-2620 facilitates better understanding of Tau deposition...
Detailed Description
The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) is a companion study to the Parkinson's Progression Markers Initiative Clinical pro...
Eligibility Criteria
Inclusion
- Enrolled in 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 \[18F\]PI-2620.
- 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.
- Females of childbearing potential have a negative urine pregnancy test prior to \[18F\]PI-2620 injection on day of PET scan.
Exclusion
- Exposure to an effective radiation dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines during the past year.
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04906590
Start Date
August 30 2021
End Date
February 1 2023
Last Update
April 21 2023
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510