NCT04935372Active, not recruiting

β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline

Source: ClinicalTrials.gov · Last updated 31 May 2025

Brief summary (registry, in English)

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).

Status (registry): Active, not recruiting
Study type: Observational
Enrollment: 200 (estimated)
First submitted: 8 Jun 2021
Start date: 25 May 2021
Primary completion date: 31 Dec 2025
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Diseases: Alzheimer disease
NCT number: NCT04935372

What you commit to

Study type: Observational
Planned participants: 200
From 25 May 2021 to the primary completion date, 31 Dec 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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. Exclusion Criteria: 1. 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.

Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Barcelonabeta Brain Research Center Coordinator of this site? Confirm its status	Barcelona	Spain	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.