Tau Tracer Comparison for Alzheimer's Disease
(HEAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial uses special imaging agents to help visualize harmful brain proteins in people at risk of Alzheimer's disease. The agents make these proteins glow during scans, allowing doctors to see them clearly and monitor the disease.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but if any medication could increase risk, limit tolerance, or interfere with the study, you might need to stop taking it. This decision will be made by the investigator.
Is 18F-Flortaucipir safe for human use?
What makes the drug 18F-Flortaucipir unique for Alzheimer's disease?
18F-Flortaucipir is unique because it is a PET imaging agent specifically designed to target and visualize tau protein deposits in the brain, which are a hallmark of Alzheimer's disease. This allows for a more precise diagnosis and understanding of the disease progression compared to other treatments that do not specifically target tau.12346
What data supports the effectiveness of the drug 18F-Flortaucipir in Alzheimer's disease?
Who Is on the Research Team?
Tharick Pascoal, MD PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for people aged 50-90 with no cognitive impairment, mild cognitive impairment, or Alzheimer's disease. They must be able to undergo repeated MR/PET imaging and have someone who can report on their functioning. Pregnant women and those unable to consent or at increased risk due to other conditions/medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline PET scans with Flortaucipir and MK-6240, amyloid-β PET scan, MRI, cognitive tests, and blood draw for biomarkers
Follow-up Assessment
Participants undergo follow-up PET scans with Flortaucipir and MK-6240, amyloid-β PET scan, MRI, cognitive tests, and blood draw for biomarkers approximately 18 months after baseline
Long-term Follow-up
Participants are monitored for changes in tau PET uptake values and associations with cognitive and biomarker measures
What Are the Treatments Tested in This Trial?
Interventions
- 18F-Flortaucipir radiopharmaceutical
- 18F-MK-6240 radiopharmaceutical
- Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)
18F-Flortaucipir radiopharmaceutical is already approved in United States, European Union for the following indications:
- Estimating the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adults with cognitive impairment who are being evaluated for Alzheimer's disease
- Diagnosis of Alzheimer's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tharick Pascoal
Lead Sponsor
National Institute on Aging (NIA)
Collaborator