Alzheimer Diseaseβ-AARCNCT04935372
β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline
An observational study of Alzheimer Disease and Preclinical Alzheimer, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial summary
The overall (cross-sectional) objective of this study is to detect and describe the profile of AD-related blood biomarkers in a population with SCD (including individuals with MCI) with the ultimate goal of investigating their capacity to predict underlying AD pathology. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Disease, Preclinical Alzheimer, Mild Cognitive Impairment
- What is being tested?
- Observational
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two-hundred participants, aged 55 to 80 years with subjective cognitive decline, will be primarily selected from the population seeking medical advice on their cognitive performance to Primary care units. In addition, other conventional recruitment strategies may be used (e.g. participants of ongoing or ended BBRC-sponsored studies,novel recruitment calls…).
Who may be able to join
- Cognitively unimpaired persons with SCD as well as individuals with MCI.
- To sign the study informed consent form, approved by the corresponding authorities.
- Participation (in-person at the institution or telephonically) of a relative to inform on the participant subjective memory decline and on the clinical interview*.
- Men and women between 55 and 80 years old
- Memory Alteration Test (M@T) ≤45
- Good knowledge of the either Spanish or Catalan language and being literate.
Who cannot join
- Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, or any other condition that might impact cognition or performance on cognitive assessments as judged by the investigator
- Parkinson's disease, epilepsy in treatment and with frequent seizures (> 1 / month) in the last year, multiple sclerosis or other neurodegenerative disease.
- Contraindication to perform an MR scan: claustrophobia, pacemaker, metallic implants, etc.
- Contraindication to lumbar puncture
- Acquired brain injury: history of cranioencephalic trauma with gross parenchymal or extra axial lesion, hemorrhagic ischemic stroke, brain tumors and other aetiologies that can cause acquired brain damage (chemotherapy or brain radiotherapy).
- Investigator's criteria: Subjects that show any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and / or in their future permanence in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The overall (cross-sectional) objective of this study is to detect and describe the profile of AD-related blood biomarkers in a population with SCD (including individuals with MCI) with the ultimate goal of investigating their capacity to predict underlying AD pathology. Longitudinally, the β-AARC_BBRC2021 study fundamentally aims at assessing the ability of AD-related blood-based biomarkers to predict disease progression in the Alzheimer's continuum.
To achieve these cross-sectional and longitudinal objectives, an exhaustive set of clinical, risk factors, cognitive, mental health and neuroimaging data will be collected, as well as blood and CSF samples, from which AD-related fluid biomarkers will be determined.
As a secondary objective, we will investigate the efficacy and accuracy of the Altoida NMI as a novel digital biomarker for identifying patients with SCD or MCI that have underlying AD pathology (cross-sectionally) and to test the capacity of the Altoida NMI to track disease progression in these popoulations (longitudinally).
- Being tested
- Observational
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Cross sectional analyses The two main variables for the analysis will be: Values of biomarker concentrations in blood and their correlations with CSF biomarkers and the development of prodromal AD for the cognitively unimpaired SCD population. Other variables of interest for the study are, among others, risk factors, cognitive status, measurements of brain structure and function, mental health, chronic diseases, environmental exposures, age and sex.
Longitudinal analyses Longitudinal analyses will estimate the association between the intensity of the subjective complaint and the rate of progression between the diagnostic categories; The association of biomarkers, risk factors and other clinical variables with the rate of progression between the diagnostic categories; The association of cognitive and neuroimaging variables with the rate of progression between the diagnostic categories; The evolution of the complaint itself and its relation to the other variables described.
| Study group | Role | What they receive |
|---|---|---|
| Subjective cognitive decline | Male and female, aged 55 to 80 years with subjective cognitive decline, either cognitively unimpaired or with mild cognitive impairment Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Aβ42/Aβ40 ratio
The capacity of plasma biomarkers to predict (alone or in combination of covariates) Alzheimer's pathology
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Cost effectiveness
The ratio between the cost and predictive capacity of these variables will be considered to derive a triaging algorithm for primary care
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start25 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
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
- NCT04935372
- Sponsor's protocol ID
- β-AARC_BBRC2021
- Acronym
- β-AARC
- 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
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
- β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT04935372
- Acronym / sponsor ID
- β-AARC / β-AARC_BBRC2021
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 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 overall (cross-sectional) objective of this study is to detect and describe the profile of AD-related blood biomarkers in a population with SCD (including individuals with MCI) with the ultimate goal of investigating their capacity to predict underlying AD pathology. Longitudinally, the β-AARC_BBRC2021 study fundamentally aims at assessing the ability of AD-related blood-based biomarkers to predict disease progression in the Alzheimer's continuum.
To achieve these cross-sectional and longitudinal objectives, an exhaustive set of clinical, risk factors, cognitive, mental health and neuroimaging data will be collected, as well as blood and CSF samples, from which AD-related fluid biomarkers will be determined.
As a secondary objective, we will investigate the efficacy and accuracy of the Altoida NMI as a novel digital biomarker for identifying patients with SCD or MCI that have underlying AD pathology (cross-sectionally) and to test the capacity of the Altoida NMI to track disease progression in these popoulations (longitudinally).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjective cognitive decline | – | Other: ObservationalMale and female, aged 55 to 80 years with subjective cognitive decline, either cognitively unimpaired or with mild cognitive impairment |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two-hundred participants, aged 55 to 80 years with subjective cognitive decline, will be primarily selected from the population seeking medical advice on their cognitive performance to Primary care units. In addition, other conventional recruitment strategies may be used (e.g. participants of ongoing or ended BBRC-sponsored studies,novel recruitment calls…).
Key inclusion criteria (6 listed)
- Cognitively unimpaired persons with SCD as well as individuals with MCI.
- To sign the study informed consent form, approved by the corresponding authorities.
- Participation (in-person at the institution or telephonically) of a relative to inform on the participant subjective memory decline and on the clinical interview*.
- Men and women between 55 and 80 years old
- Memory Alteration Test (M@T) ≤45
Key exclusion criteria (6 listed)
- Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, or any other condition that might impact cognition or performance on cognitive assessments as judged by the investigator
- Parkinson's disease, epilepsy in treatment and with frequent seizures (> 1 / month) in the last year, multiple sclerosis or other neurodegenerative disease.
- Contraindication to perform an MR scan: claustrophobia, pacemaker, metallic implants, etc.
- Contraindication to lumbar puncture
- Acquired brain injury: history of cranioencephalic trauma with gross parenchymal or extra axial lesion, hemorrhagic ischemic stroke, brain tumors and other aetiologies that can cause acquired brain damage (chemotherapy or brain radiotherapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalCross sectional analyses The two main variables for the analysis will be: Values of biomarker concentrations in blood and their correlations with CSF biomarkers and the development of prodromal AD for the cognitively unimpaired SCD population. Other variables of interest for the study are, among others, risk factors, cognitive status, measurements of brain structure and function, mental health, chronic diseases, environmental exposures, age and sex. Longitudinal analyses Longitudinal analyses will estimate the association between the intensity of the subjective complaint and the rate of progression between the diagnostic categories; The association of biomarkers, risk factors and other clinical variables with the rate of progression between the diagnostic categories; The association of cognitive and neuroimaging variables with the rate of progression between the diagnostic categories; The evolution of the complaint itself and its relation to the other variables described. | Other | Subjective cognitive decline |
Primary outcome
CSF Aβ42/Aβ40 ratio
Time frame: Through study completion, an average of 1 year
The capacity of plasma biomarkers to predict (alone or in combination of covariates) Alzheimer's pathology
1 secondary outcome
Cost effectiveness
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Alzheimer Disease and Preclinical Alzheimer, 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 6 inclusion and 6 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
CSF Aβ42/Aβ40 ratio (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.