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Clinical Trials/NCT04932473
NCT04932473
Completed
Not Applicable

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

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation1 site in 1 country179 target enrollmentJanuary 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitively Unimpaied
Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Enrollment
179
Locations
1
Primary Endpoint
Sleep quality
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2021
End Date
May 27, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Sleep quality

Time Frame: up to 2 weeks

Actigraphy-derived sleep quality measures

Study Sites (1)

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