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

NCT ID: NCT04932473

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2025-05-27

Brief Summary

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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

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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.

Conditions

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Cognitively Unimpaied

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barcelonabeta Brain Research Center

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Fauria K, Minguillon C, Knezevic I, Tort-Colet N, Stankeviciute L, Hernandez L, Radoi A, Deulofeu C, Fuentes-Julian S, Turull I, Fuste D, Sanchez-Benavides G, Arenaza-Urquijo EM, Suarez-Calvet M, Holst SC, Garces P, Mueggler T, Zetterberg H, Blennow K, Arqueros A, Iranzo A, Domingo Gispert J, Molinuevo JL, Grau-Rivera O. Exploring cognitive and biological correlates of sleep quality and their potential links with Alzheimer's disease (ALFASleep project): protocol for an observational study. BMJ Open. 2022 Dec 30;12(12):e067159. doi: 10.1136/bmjopen-2022-067159.

Reference Type DERIVED
PMID: 36585141 (View on PubMed)

Other Identifiers

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ALFAsleep-BBRC2018

Identifier Type: -

Identifier Source: org_study_id

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