This study is currently not recruiting participants.

Longitudinal Early-onset Alzheimer's Disease Study (LEADS)

  • STATUS
    Not Recruiting
Updated on 19 February 2024

Summary

This is a non-randomized, natural history, non-treatment study. Assessments are to be collected at baseline and Year 1 (both Early Onset Alzheimer?s Disease (EOAD) and Cognitively Normal (CN) cohorts) and Year 2 (EOAD cohort only).

The primary objectives are to collect longitudinal assessments and biomarker data for 400 EOAD and 100 CN participants; compare baseline and longitudinal cognitive and functional characteristics, between EOAD and CN, and EOAD and Late Onset Alzheimer?s Diseases (LOAD) from the Alzheimer?s Disease Neuroimaging Initiative (ADNI); and study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade.

The scientific aims are to compare the baseline and longitudinal cognitive and functional characteristics of EOAD compared to LOAD and identify optimal outcome measures for clinical trials; compare baseline and longitudinal MRI, amyloid PET, tau PET and cerebrospinal fluid measures between EOAD and LOAD and identify optimal imaging outcome measures for clinical trials; investigate the influence of APOE genotype on baseline and longitudinal imaging biomarkers and clinical phenotype in EOAD; and characterize genetic contributions to EOAD and obtain annually an array of uniformly collected biospecimens for future biomarker development.

Description

This is a non-randomized, natural history, non-treatment study. Assessments are to be collected at baseline and Year 1 (both Early Onset Alzheimer?s Disease (EOAD) and Cognitively Normal (CN) cohorts) and Year 2 (EOAD cohort only).

The primary objectives are to collect longitudinal assessments and biomarker data for 400 EOAD and 100 CN participants; compare baseline and longitudinal cognitive and functional characteristics, between EOAD and CN, and EOAD and Late Onset Alzheimer?s Diseases (LOAD) from the Alzheimer?s Disease Neuroimaging Initiative (ADNI); and study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade.

The scientific aims are to compare the baseline and longitudinal cognitive and functional characteristics of EOAD compared to LOAD and identify optimal outcome measures for clinical trials; compare baseline and longitudinal MRI, amyloid PET, tau PET and cerebrospinal fluid measures between EOAD and LOAD and identify optimal imaging outcome measures for clinical trials; investigate the influence of APOE genotype on baseline and longitudinal imaging biomarkers and clinical phenotype in EOAD; and characterize genetic contributions to EOAD and obtain annually an array of uniformly collected biospecimens for future biomarker development.

Details
Condition Alzheimer's Disease
Age 100years or below
Clinical Study IdentifierTX8671
Last Modified on19 February 2024

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