Summary

Eligibility
for people ages 20-90 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by David Soleimani-Meigooni, MD

Description

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.

Official Title

Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers

Details

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.

Keywords

Alzheimer Disease Tau PET Neurofibrillary tangles Alzheimer's disease Tauopathies Biomarkers Radiopharmaceuticals 18F-Flortaucipir radiopharmaceutical 18F-MK-6240 radiopharmaceutical Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)

Eligibility

You can join if…

Open to people ages 20-90

  • 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.

You CAN'T join if...

  • 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).

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Lawrence Berkeley National Laboratory not yet accepting patients
    Berkeley California 94720 United States

Lead Scientist at UCSF

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Tharick Pascoal
ID
NCT05361382
Phase
Phase 1 Alzheimer's Disease Research Study
Study Type
Interventional
Participants
Expecting 620 study participants
Last Updated