Actively Recruiting
Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Disease Using the PET Ligand [18F]-PI-2620
Led by University of Pennsylvania · Updated on 2025-11-04
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing brain scans using the [18F]-PI-2620 tracer in people with frontotemporal lobar degeneration (FTLD), non-amnestic Alzheimer's disease (naAD), and healthy adults. This study builds upon a larger observational research project (UNICORN) that collects brain imaging, clinical assessments, and genetic data to better understand neurodegenerative diseases. Participants include various groups diagnosed by neurologists, aiming to see how tau protein accumulates in different conditions. Participants undergo a baseline PET/CT brain scan with the [18F]-PI-2620 tracer. If funding allows, some may return for additional scans 12 to 24 months apart to monitor changes over time. Seven groups are studied, including healthy adults, different types of FTLD, and Alzheimer's subtypes. Each participant will have at least one PET scan to assess tau accumulation in the brain. During the study, participants continue their involvement in the UNICORN observational study, which includes periodic MRI scans and neuropsychological testing. Researchers measure brain tau levels using PET scan results and track cognitive and functional abilities. Safety is monitored, and participants provide informed consent. The study plans to collect data over about six years, with ongoing assessments of brain imaging and clinical status.
CONDITIONS
Brief Title
PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and currently enrolled in the UNICORN study
- Cognitively and neurologically normal adults or clinically diagnosed with specific neurodegenerative conditions including non-amnestic or amnestic Alzheimer's disease, frontotemporal lobar degeneration (FTLD) with tau or TDP-43 pathology, or genetic forms of FTLD
- Not clinically depressed based on Geriatric Depression Scale score 6 or clinical evaluation
- Have a study partner and legally authorized representative (LAR) if applicable
- For genetic groups, must have a confirmed mutation in the MAPT, GRN, or C9orf72 genes or be an asymptomatic carrier
- Diagnosed by trained clinicians according to established criteria for each group
You will not qualify if you...
- Presence of medical or psychiatric conditions that could compromise safety or study participation
- Evidence of major stroke or brain mass on MRI within 6 months prior to enrollment
- Unable to tolerate or contraindicated for imaging procedures
- Pregnant or breastfeeding females at the time of PET/CT scan
- History of significant alcohol or substance abuse or dependence
- Currently enrolled in a clinical trial for a disease-modifying treatment targeting their neurodegenerative condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment documentation is completed through the parent UNICORN study.
Duration - Single visit
Participants undergo a baseline PET/CT brain imaging scan using the [18F]-PI-2620 tracer to assess tau accumulation.
1 visit (in-person) for the PET/CT scan
Duration - Up to 6 years depending on funding and scheduling
Participants may return for one or more follow-up PET/CT brain scans between 12 and 24 months after the previous scan to monitor changes in tau accumulation over time.
1 to multiple visits (in-person) scheduled at least 12 months apart
Trial Site Locations
Total: 1 location
1
Perelman Center for Advance Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
D
David J Irwin, MD
J
Jeffrey S Phillips, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
7
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