Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease
NCT ID: NCT05361382
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
822 participants
INTERVENTIONAL
2022-03-02
2027-05-31
Brief Summary
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Detailed Description
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To accomplish our objectives, the investigators propose the following specific aims:
In Aim 1, investigators will standardize tau PET processing methods, convert the tracers to a common scale, compare associations with amyloid-β, atrophy, and cognition, and compare/harmonize Braak staging assessments between tau tracers using cross-sectional data.
In Aim 2, investigators will ascertain the optimal processing method for longitudinal analysis and compare longitudinal changes in tau accumulation obtained with the tau PET radiopharmaceuticals and their associations with changes in amyloid-β, atrophy, and cognition.
In Exploratory Aim 3, investigators will compare cross-sectional and longitudinal Flortaucipir and MK-6240 estimates with plasma phosphorylated tau concentrations.
This study will produce a benchmark dataset to develop methods for tau PET quantification and harmonization.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Individuals across the aging and Alzheimer's disease (AD) spectrum
All individuals enrolled into the HEAD study will undergo tau PET, amyloid-β PET, magnetic resonance imaging (MRI), detailed clinical and cognitive assessment, and a blood draw.
18F-Flortaucipir radiopharmaceutical
Flortaucipir is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 10 millicuries of the radiopharmaceutical.
18F-MK-6240 radiopharmaceutical
MK-6240 is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 5 millicuries of the radiopharmaceutical.
Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)
The clinical sites will use either PiB, Florbetaben, Flutemetamol, or NAV-4694 as the amyloid-β PET radiopharmaceutical. The amyloid-β PET radiopharmaceutical binds to amyloid-β plaques.
Participants will receive a bolus intravenous injection of approximately 15 millicuries of the PiB radiopharmaceutical.
Participants will receive a bolus intravenous injection of approximately 8 millicuries of the Florbetaben or NAV-4694 radiopharmaceutical.
Participants will receive a bolus intravenous injection of approximately 5 millicuries of the Flutemetamol radiopharmaceutical.
Interventions
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18F-Flortaucipir radiopharmaceutical
Flortaucipir is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 10 millicuries of the radiopharmaceutical.
18F-MK-6240 radiopharmaceutical
MK-6240 is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 5 millicuries of the radiopharmaceutical.
Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)
The clinical sites will use either PiB, Florbetaben, Flutemetamol, or NAV-4694 as the amyloid-β PET radiopharmaceutical. The amyloid-β PET radiopharmaceutical binds to amyloid-β plaques.
Participants will receive a bolus intravenous injection of approximately 15 millicuries of the PiB radiopharmaceutical.
Participants will receive a bolus intravenous injection of approximately 8 millicuries of the Florbetaben or NAV-4694 radiopharmaceutical.
Participants will receive a bolus intravenous injection of approximately 5 millicuries of the Flutemetamol radiopharmaceutical.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and capable of undergoing repeated MR/PET imaging.
* Fluent in a language approved by the coordinating center.
* At screening, must have no cognitive impairment, or meet criteria for single- or multiple-domain amnestic mild cognitive impairment or Alzheimer's disease dementia.
Exclusion Criteria
* Pregnant or breastfeeding women.
* Have any condition or are taking any medication that could increase the risk to the participant, limit the ability to tolerate or interfere with the results of the tests and procedures (in the opinion of the investigator).
18 Years
90 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Tharick Pascoal
OTHER
Responsible Party
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Tharick Pascoal
Associate Professor
Principal Investigators
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Tharick Pascoal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Lawrence Berkeley National Laboratory
Berkeley, California, United States
University of California San Francisco
San Francisco, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
McGill University
Montreal, Quebec, Canada
Sant Pau Biomedical Research Institute
Barcelona, Spain, Spain
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY22020056
Identifier Type: -
Identifier Source: org_study_id
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