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

NCT04932473 | Completed

• 1 other identifier: ALFAsleep-BBRC2018
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitively Unimpaied

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  Actigraphy-derived sleep quality measures

  up to 2 weeks

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 200 participants from the BBRC ALFA+ study (ALFA - FPM - 0311) will be selected based on their core AD biomarker profile to characterize their sleep quality with objective (actigraphy and RUSleeping RTS) and subjective measures. Participants will be classified into two different groups, based on previously established CSF biomarkers cut off values, as follows: 1) Controls: individuals with CSF Aβ42/ Aβ40 ratio \> 0.071 ng/mL (considered as without altered AD biomarkers). 2) Preclinical AD: individuals with CSF Aβ42/ Aβ40 ratio 0.071 ≤ ng/mL (considered as with evidence of brain amyloidosis). However, it must be noted that thresholds for core biomarker abnormalities in preclinical AD, is an ongoing field of research and that these thresholds may vary with the addition of novel data/evidence resulting from our group and others.

You may qualify if:

• Subjects from whom CSF and/or neuroimaging biomarkers have been acquired during the last 36 months prior to their enrollment in the current study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barcelonabeta Brain Research Center, Pasqual Maragall Foundation: lead

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

Location

Related Publications (1)

• 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.

  PMID: 36585141 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 21, 2021
• Study Start: January 26, 2021
• Primary Completion: September 20, 2022
• Study Completion: May 27, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (1)