ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease

• Conditions: Cognitively Unimpaied

• Registration Number: NCT04932473
• Lead Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Brief Summary

The main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in Alzheimer's disease (AD) biomarkers, as a function of sleep quality measures. Cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and AD.

Detailed Description

The main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in Alzheimer's disease (AD) biomarkers, as a function of sleep quality measures. Cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and AD.

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects that are currently participating in the ALFA+ study (cognitively healthy adults aged between 45-65 years at the moment of the inclusion in the 45-65/FPM2012 study).
• Subjects from whom CSF and/or neuroimaging biomarkers have been acquired during the last 36 months prior to their enrollment in the current study.

Exclusion Criteria

• Presence of cognitive impairment.
• Presence of clinically relevant neurological disorder, psychiatric disorder or other medical conditions that may jeopardize the interpretation of the study results according to the investigator criteria
• For the PSG sub-study, participants currently treated with drugs that may interfere in PSG data interpretation (e.g. antidepressants or benzodiazepines).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality	up to 2 weeks	Actigraphy-derived sleep quality measures

Trial Locations

Locations (1)

Barcelonabeta Brain Research Center; 🇪🇸 Barcelona, Spain