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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05361382
Other study ID # STUDY22020056
Secondary ID R01AG073267
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 23, 2021
Est. completion date May 31, 2027

Study information

Verified date November 2023
Source University of Pittsburgh
Contact Tharick Pascoal, MD PhD
Phone 412-586-9012
Email pascoal-research@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 620
Est. completion date May 31, 2027
Est. primary completion date May 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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-ß radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Florbetapir)
The clinical sites will use either PiB, Florbetaben, Florbetapir, or NAV-4694 as the amyloid-ß PET radiopharmaceutical. The amyloid-ß PET radiopharmaceutical binds to amyloid-ß 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 10 millicuries of the Florbetapir radiopharmaceutical.

Locations

Country Name City State
Canada McGill University Research Centre for Studies in Aging Montréal Quebec
Spain Sant Pau Biomedical Research Institute Barcelona
United States Lawrence Berkeley National Laboratory Berkeley California
United States Houston Methodist Neurological Institute Houston Texas
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Brown University Providence Rhode Island
United States Mayo Clinic Rochester Minnesota
United States Washington University in St. Louis Saint Louis Missouri
United States University of California San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Tharick Pascoal National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cross-sectional tau PET uptake values Compare/harmonize cross-sectional tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240. 2 years from enrollment
Primary Longitudinal change in tau PET uptake values over 18 months Compare/harmonize change in tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 between baseline and 18-month follow-up assessments. 5 years from enrollment
Secondary Associations of tau PET uptake values with amyloid-ß PET uptake values Compare the effect size of the associations of tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 with amyloid-ß deposition measurements (SUVR). 5 years from enrollment
Secondary Associations of tau PET uptake values with measures of cognition Compare the effect size of the associations of tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 with cognitive measures assessed from neuropsychological evaluation. 5 years from enrollment
Secondary Associations of tau PET uptake values blood biomarkers Compare the effect size of the associations of tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 with blood-based biomarkers of tau. 5 years from enrollment
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