NCT04935372 · ACTIVE NOT RECRUITING
β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline
This observational cohort study is testing whether blood-based biomarkers can detect early Alzheimer's-related changes in people who have subjective memory concerns or mild cognitive impairment. Researchers are also evaluating a digital tool called Altoida NMI as a way to track disease progression. No drug or treatment is involved. This is not a clinical trial of a therapy — it is a data-collection study to improve how we identify and monitor early Alzheimer's pathology.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-31