Alzheimer's Disease (AD), a fatal neurodegenerative disorder characterized by progressive cognitive impairment and memory loss, is the major cause of dementia. The two main neuropathological hallmarks of AD are extracellular amyloid plaques, and neurofibrillary tangles (NTFs), primarily composed of the protein tau.
A biomarker is a characteristic that can be objectively measured and evaluated as an indicator of a normal or pathological process, or as a measure of response to therapy. Application of cerebrospinal fluid-based (CSF) and blood-based biomarkers in clinical research has revolutionized the understanding of AD. Especially, detection of Aβ and tau in CSF has led to crucial advancements in disease detection at its earliest stage (Fig 1).
In general, biomarkers have proven extremely useful throughout the different steps of AD clinical trials: patient inclusion and enrichment, and evaluation of target engagement and clinical efficacy of therapeutic drugs. Changes in CSF and blood-based biomarkers reflect different pathological processes in AD.
Informed Decision-Making. Quality Data. Improved Outcomes.
Bioclinica AD biochemical marker capabilities:
- Fit-for-Purpose Validation
- Expertise in Sample Handling
- Centralized analysis to minimize assay variability
- Controlled storage of biological samples
- Established partnership with internationally recognized KOL
- AD specific Proficiency Testing Program
Fluid-based biomarkers can facilitate development of new AD therapies by allowing:
- Enrichment and stratification of patients
- Evaluation of target engagment
- Measurement of disease progression
- Clinical efficacy and safety assessment of therapeutic drugs