PPMI Tau PET Imaging

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Michael J. Fox Foundation for Parkinson's Research
• Collaborator: Institute for Neurodegenerative Disorders

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.