PPMI Tau PET Imaging

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: [18F] PI-2620

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 protocol (PPMI-002; NCT04477785). After consenting to the PPMI Clinical protocol, participants interested in completing an additional scan under this study will be asked to complete consent, additional activities, and one [18F]PI-2620 PET imaging scan as part of this study. Enrollment in the PPMI Tau PET Imaging companion study will facilitate comparison of tau deposition to clinical, imaging, blood and CSF tau already acquired in these PPMI participants under the PPMI Clinical protocol. The primary goal of this imaging study is to test whether positron emission tomography (PET) with [18F] PI-2620 can visualize in vivo brain tau deposition in participants with PD. The secondary goal is to evaluate tau deposition in PD LRRK2 mutation carriers given recent data that tau pathology may be present in those individuals.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Drug; All participants will receive PI-2620.	Drug: [18F] PI-2620; Evaluation of the radiopharmaceutical imaging agent PI-2620 in detecting TAU brain burden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PPMI-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No