β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjec… (NCT04935372) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective Cognitive Decline
Spain200 participantsStarted 2021-05-25
Plain-language 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).
Who can participate
Age range55 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
CSF Aβ42/Aβ40 ratio
Timeframe: Through study completion, an average of 1 year
Trial details
NCT IDNCT04935372
SponsorBarcelonabeta Brain Research Center, Pasqual Maragall Foundation
✕. 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.