Identifying blood biomarkers for cognitive decline and Alzheimer's disease

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

This study is trying to find blood tests that can help spot signs of Alzheimer's disease in people who are starting to have memory problems.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Barcelona)
• Trial ID: NCT04935372 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify blood-based biomarkers associated with Alzheimer's disease (AD) in individuals experiencing subjective cognitive decline (SCD) and mild cognitive impairment (MCI). It will collect a comprehensive set of clinical, cognitive, and neuroimaging data, along with blood and cerebrospinal fluid samples, to evaluate the potential of these biomarkers in predicting underlying AD pathology and disease progression. Additionally, the study will assess the effectiveness of a novel digital biomarker, the Altoida NMI, in identifying patients with SCD or MCI who may have underlying AD.

Who should consider this trial

Good fit: Ideal candidates include cognitively unimpaired individuals aged 55 to 80 with subjective memory decline or those diagnosed with mild cognitive impairment.

Not a fit: Patients with clinically relevant psychiatric disorders or other neurological conditions that affect cognition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and better management of Alzheimer's disease through the identification of reliable blood biomarkers.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for Alzheimer's disease, but this specific approach focusing on blood-based biomarkers in SCD and MCI populations is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Cognitively unimpaired persons with SCD as well as individuals with MCI.
2. To sign the study informed consent form, approved by the corresponding authorities.
3. Participation (in-person at the institution or telephonically) of a relative to inform on the participant subjective memory decline and on the clinical interview\*.
4. Men and women between 55 and 80 years old
5. Memory Alteration Test (M@T) ≤45
6. 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
2. Parkinson's disease, epilepsy in treatment and with frequent seizures (\> 1 / month) in the last year, multiple sclerosis or other neurodegenerative disease.
3. Contraindication to perform an MR scan: claustrophobia, pacemaker, metallic implants, etc.
4. Contraindication to lumbar puncture
5. 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).
6. 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.

Where this trial is running

Barcelona

• BarcelonaBeta Brain Research Center — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Carolina Minguillon, PhD

Conditions Alzheimer Disease; Preclinical Alzheimer; Mild Cognitive Impairment