Alzheimer Disease Clinical Trial
— HEADOfficial title:
Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Tharick Pascoal | National Institute on Aging (NIA) |
United States, Canada, Spain,
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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