Actively Recruiting
Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Led by University of Alabama at Birmingham · Updated on 2025-12-11
60
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
M
Michael J. Fox Foundation for Parkinson's Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A prodromal PD or healthy participant enrolled in the PPMI clinical protocol
- A PD participant enrolled in the PPMI clinical protocol who has not started symptomatic treatment at enrollment or within the first 2 years of participation
- Able to provide informed consent
- Must have screening genetic testing showing high binder status at the TSPO gene polymorphism (rs6971)
- Male or female (females must meet additional birth control or non-childbearing criteria)
- Females must be of non-childbearing potential or using a highly effective birth control method 14 days before until at least 24 hours after injection
- Non-childbearing potential means postmenopausal for at least 12 months or surgically sterile
- Highly effective birth control includes methods with less than 1% failure rate, such as oral contraceptives for at least 3 months, IUD for at least 2 months, or barrier methods; periodic abstinence methods are not acceptable
- Females of childbearing potential must not be pregnant, breastfeeding, or lactating and must have a negative urine pregnancy test on the day of PET scan
You will not qualify if you...
- Exposure to a total effective dose equivalent of 50 millisievert (mSv) or more to the whole body within the past year
- Any other medical or psychiatric condition or laboratory abnormality that the site investigator believes would prevent participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UAB
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
E
Evan Hudson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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