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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04932473
Enrollment
179
Registered
2021-06-21
Start date
2021-01-26
Completion date
2025-05-27
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitively Unimpaied

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.

Interventions

None listed

Sponsors

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Sleep qualityup to 2 weeksActigraphy-derived sleep quality measures

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026