PPMI Tau PET Imaging

NCT04906590 | Completed Phase 2 FDA Drug

• 1 other identifier: PPMI-008
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 in the brain in Parkinson's disease (PD).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Determination of [18F]PI-2620 standard uptake value ratio (SUVR) targeting brain tau deposition in comparison between Parkinson disease and healthy control participants.

  90 minutes

Study Arms (1)

Study Drug

EXPERIMENTAL

All participants will receive PI-2620.

Drug: [18F] PI-2620

Interventions

[18F] PI-2620 DRUG

Evaluation of the radiopharmaceutical imaging agent PI-2620 in detecting TAU brain burden.

Study Drug

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: lead
• Institute for Neurodegenerative Disorders: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 28, 2021
• Study Start: August 30, 2021
• Primary Completion: January 30, 2023
• Study Completion: February 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (1)