Loading clinical trials...

PPMI Tau PET Imaging | Clinical Trials | Clareo Health

COMPLETEDPHASE2

PPMI Tau PET Imaging

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

NCT04906590•Michael J. Fox Foundation for Parkinson's Research

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).

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.

Eligibility

Age

30 - 100 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Key Dates

Start Date

August 30, 2021

Primary Completion Date

January 30, 2023

Completion Date

February 1, 2023

Last Updated

April 21, 2023

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

[18F] PI-2620

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PPMI Tau PET Imaging

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients