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

Last updated: April 22, 2025
Sponsor: Tharick Pascoal
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

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

18F-Flortaucipir radiopharmaceutical

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

Clinical Study ID

NCT05361382
STUDY22020056
R01AG073267
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Have an informant who will be able to provide an independent evaluation offunctioning.

  • 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- ormultiple-domain amnestic mild cognitive impairment or Alzheimer's disease dementia.

Exclusion

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 theparticipant, limit the ability to tolerate or interfere with the results of thetests and procedures (in the opinion of the investigator).

Study Design

Total Participants: 620
Treatment Group(s): 4
Primary Treatment: Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)
Phase: 1
Study Start date:
November 23, 2021
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • McGill University

    Montréal, Quebec H3A 0G4
    Canada

    Site Not Available

  • McGill University Research Centre for Studies in Aging

    Montréal, Quebec H4H1V3
    Canada

    Active - Recruiting

  • Sant Pau Biomedical Research Institute

    Barcelona, 08025
    Spain

    Site Not Available

  • Lawrence Berkeley National Laboratory

    Berkeley, California 94720
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Brown University

    Providence, Rhode Island 02912
    United States

    Site Not Available

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Site Not Available

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