Actively Recruiting
Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
Led by Michael J. Fox Foundation for Parkinson's Research · Updated on 2025-06-13
60
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
M
Michael J. Fox Foundation for Parkinson's Research
Lead Sponsor
I
Institute for Neurodegenerative Disorders
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study aims to evaluate the burden of tau pathology in people with Sporadic and LRRK2 PD via in vivo imaging using the tau tracer, \[18F\]PI-2620, and a high resolution PET camera, NeuroEXPLORER.
CONDITIONS
Official Title
Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to comply with study procedures and attend follow-up visits
- Provided written informed consent
- Male or female aged 45 to 85 years
- Females must be of non-childbearing potential or use highly effective birth control from 14 days before until 24 hours after tracer injection
- Females of childbearing potential must not be pregnant, breastfeeding, or planning pregnancy during study
- Non-PPMI females of childbearing potential must have negative pregnancy tests at screening and before tracer injection
- Healthy controls must be enrolled in the PPMI study as healthy subjects
- Parkinson's disease participants must be enrolled in PPMI as sporadic or LRRK2 PD with known CSF alpha synuclein and plasma phosphorylated Tau217 status
- PSP participants must have diagnosis based on Movement Disorder Society criteria, symptom onset within 2-5 years, progressive motor symptoms, and evidence of striatal degeneration
- CBS participants must have diagnosis based on clinical criteria with asymmetric motor and cognitive dysfunction, specific symptoms, cognitive decline, and evidence of striatal degeneration
You will not qualify if you...
- Any medical or psychiatric condition or lab abnormality that could preclude participation
- Receiving medications that interfere with DaTscan imaging and unwilling or unable to stop them for five half-lives before screening
- Use of dopamine receptor blockers, metoclopramide, or reserpine within 6 months prior to baseline or screening
- Structural brain abnormalities on MRI suggesting significant neurological disorders outside study diseases
- Any condition or abnormal labs that in investigator's opinion could interfere with safety or suitability for study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute for Neurodegenerative Disorders / XingImaging, LLC
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
A
Ashley Romano, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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