RecruitingEarly Phase 1NCT06289582

Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)


Sponsor

University of Alabama at Birmingham

Enrollment

60 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is researching brain inflammation in people with Parkinson's disease (PD) and those who may be at risk of developing it. Researchers use a special brain scan called a PET scan with a radioactive tracer ([18F]DPA-714) to measure inflammation over time. **You may be eligible if...** - You are already enrolled in the PPMI clinical research program as a PD patient, a prodromal (at-risk) participant, or a healthy volunteer - You have not yet started medication for Parkinson's symptoms (or have been in the study less than 2 years) - Genetic testing confirms you are a "high binder" at a specific gene related to the brain scan tracer (TSPO rs6971) - Women must be postmenopausal, surgically unable to have children, or using highly effective contraception **You may NOT be eligible if...** - You are not already part of the PPMI study - Your genetic test shows you are not a "high binder" at the TSPO gene - You are pregnant or not using effective birth control (if female and of childbearing age) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[F-18]DPA714 administration IV

brain PET/MRI imaging after \[F-18\]DPA-714 administration


Locations(1)

UAB

Birmingham, Alabama, United States

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NCT06289582


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