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PET Scan with DPA-714 for Parkinson's Disease
Phase 1 & 2
Recruiting
Led By Jonathan McConathy, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will measure the level of neuroinflammation in the brains of people with Parkinson's disease compared to healthy controls, using a PET scan with the tracer [18F]DPA-714.
Who is the study for?
This trial is for participants already enrolled in the UAB Neuroinflammation in Parkinson's Disease study. It's specifically for those who can undergo PET/MRI scans and are not pregnant or at risk of pregnancy. Individuals must have a certain genetic profile (high or mixed affinity binder) that allows them to bind well with the imaging agent used.
What is being tested?
The substudy is testing how a PET tracer called [18F]DPA-714 distributes and concentrates in the brain, which could indicate levels of neuroinflammation in Parkinson’s patients compared to healthy individuals. The tracer binds to proteins associated with inflammation in brain immune cells.
What are the potential side effects?
While specific side effects are not listed, typical risks may include reactions to the PET tracer, discomfort from lying still during imaging, and potential issues related to MRI such as claustrophobia or reactions to contrast agents if used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls.
Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: UDALL 5-year Follow-up CohortExperimental Treatment1 Intervention
n-67 from baseline early Parkinson's disease cohort
Group II: Metabolite Analysis CohortExperimental Treatment1 Intervention
n-5 from baseline early Parkinson's disease cohort
Group III: Baseline Cohort Healthy Controls, DPA-714-PET/MRIExperimental Treatment1 Intervention
n-105
Group IV: Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRIExperimental Treatment1 Intervention
n-100
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,443,603 Total Patients Enrolled
Jonathan McConathy, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or have been menopausal for over a year or am surgically sterilized.My genetic test shows I'm a low-affinity binder for TSPO.I am 30 years old or older.My genetic test shows I have a specific marker (rs6971) for treatment response.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline Cohort Healthy Controls, DPA-714-PET/MRI
- Group 2: Metabolite Analysis Cohort
- Group 3: Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI
- Group 4: UDALL 5-year Follow-up Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.