NCT04935372

β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The overall (cross-sectional) objective of this study is to detect and describe the profile of AD-related blood biomarkers in a population with SCD (including individuals with MCI) with the ultimate goal of investigating their capacity to predict underlying AD pathology. Longitudinally, the β-AARC\_BBRC2021 study fundamentally aims at assessing the ability of AD-related blood-based biomarkers to predict disease progression in the Alzheimer's continuum. To achieve these cross-sectional and longitudinal objectives, an exhaustive set of clinical, risk factors, cognitive, mental health and neuroimaging data will be collected, as well as blood and CSF samples, from which AD-related fluid biomarkers will be determined. As a secondary objective, we will investigate the efficacy and accuracy of the Altoida NMI as a novel digital biomarker for identifying patients with SCD or MCI that have underlying AD pathology (cross-sectionally) and to test the capacity of the Altoida NMI to track disease progression in these popoulations (longitudinally).

Conditions

• Alzheimer Disease
• Preclinical Alzheimer
• Mild Cognitive Impairment

Interventions

Type	Name	Description
OTHER	Observational	Cross sectional analyses The two main variables for the analysis will be: Values of biomarker concentrations in blood and their correlations with CSF biomarkers and the development of prodromal AD for the cognitively unimpaired SCD population. Other variables of interest for the study are, among others, risk factors, cognitive status, measurements of brain structure and function, mental health, chronic diseases, environmental exposures, age and sex. Longitudinal analyses Longitudinal analyses will estimate the association between the intensity of the subjective complaint and the rate of progression between the diagnostic categories; The association of biomarkers, risk factors and other clinical variables with the rate of progression between the diagnostic categories; The association of cognitive and neuroimaging variables with the rate of progression between the diagnostic categories; The evolution of the complaint itself and its relation to the other variables described.

Timeline

• Start date: 2021-05-25
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-06-23
• Last updated: 2025-05-31

Locations

1 site across 1 country: Spain