Assessment of Brain Tau Burden in Participants With Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging)

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 in the brain in Parkinson's disease (PD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 100
Healthy Volunteers: t
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• 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.

Locations
United States
Connecticut
Institute for Neurodegenerative Disorders
New Haven
Time Frame
Start Date: 2021-08-30
Completion Date: 2023-02-01
Participants
Target number of participants: 23
Treatments
Experimental: Study Drug
All participants will receive PI-2620.
Related Therapeutic Areas
Sponsors
Collaborators: Institute for Neurodegenerative Disorders
Leads: Michael J. Fox Foundation for Parkinson's Research

This content was sourced from clinicaltrials.gov