Cognitively UnimpaiedNCT04932473
ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease
An observational study of Cognitively Unimpaied, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitively Unimpaied
- How many people
- 179 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2021to 27 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cognitively Unimpaied
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Actigraphy-derived sleep quality measures
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start26 Jan 2021
- Primary completion20 Sep 2022
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitively UnimpaiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932473
- Sponsor's protocol ID
- ALFAsleep-BBRC2018
- Status last verified
- May 2025
- First submitted
- 8 Jun 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36585141
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04932473
- Acronym / sponsor ID
- ALFAsleep-BBRC2018
- Conditions
- Cognitively Unimpaied
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep quality
Time frame: up to 2 weeks
Actigraphy-derived sleep quality measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 36585141Fauria 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitively Unimpaied, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.