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NCT05361382 | Not yet recruiting | Alzheimer Disease

Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease

Tharick Pascoal

Information provided by (Responsible Party):

Tharick Pascoal

Brief Summary:

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

Condition or disease

Alzheimer Disease


18F-Flortaucipir radiopharmaceutical

18F-MK-6240 radiopharmaceutical

Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)


Phase 1

Detailed Description:

This is a longitudinal, multi-site, non-randomized study in which the participants will undergo Flortaucipir and MK-6240 PET scans at baseline and approximately at 18-month follow-up. At each time point, participants will also have an amyloid-β PET scan, magnetic resonance imaging, detailed cognitive tests, and a blood draw for biomarker quantification. The main objectives of this study are standardizing tau PET tracers' outcomes and comparing their performance. 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.

Study Type : Interventional
Estimated Enrollment : 620 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers
Actual Study Start Date : August 2022
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : May 31, 2027
Arm Intervention/treatment

Experimental: Individuals across the aging and Alzheimer's disease (AD) spectrum

Approximately 620 individuals (40 young healthy, 280 cognitively unimpaired older, 200 mild cognitive impairment, and 100 Alzheimer's disease dementia) will be enrolled in the HEAD study.

Drug: 18F-Flortaucipir radiopharmaceutical

Drug: 18F-MK-6240 radiopharmaceutical

Drug: Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)

Ages Eligible for Study: 20 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Inclusion criteria
  • Have an informant who will be able to provide an independent evaluation of functioning.
  • 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
    • Inability to provide informed consent by self or by proxy.
    • 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).

Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease

Location Details

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Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.


Not yet recruiting

United States, California

Lawrence Berkeley National Laboratory

Berkeley, California, United States, 94720

Not yet recruiting

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

Not yet recruiting

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Not yet recruiting

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63130

Not yet recruiting

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Not yet recruiting

United States, Rhode Island

Brown University

Providence, Rhode Island, United States, 02912

Not yet recruiting

United States, Texas

Houston Methodist Neurological Institute

Houston, Texas, United States, 77030

Not yet recruiting

Canada, Quebec

McGill University Research Centre for Studies in Aging

Montréal, Quebec, Canada, H4H1V3