β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline
- Conditions
- Preclinical AlzheimerAlzheimer DiseaseMild Cognitive Impairment
- Interventions
- Other: Observational
- Registration Number
- NCT04935372
- Lead Sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Brief 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. 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjective cognitive decline Observational Male and female, aged 55 to 80 years with subjective cognitive decline, either cognitively unimpaired or with mild cognitive impairment
- Primary Outcome Measures
Name Time Method CSF Aβ42/Aβ40 ratio Through study completion, an average of 1 year The capacity of plasma biomarkers to predict (alone or in combination of covariates) Alzheimer's pathology
- Secondary Outcome Measures
Name Time Method Cost effectiveness Through study completion, an average of 1 year The ratio between the cost and predictive capacity of these variables will be considered to derive a triaging algorithm for primary care
Trial Locations
- Locations (1)
BarcelonaBeta Brain Research Center
🇪🇸Barcelona, Spain