Neurological biomarkers are advancing for diseases like Parkinson’s and Alzheimer’s, improving diagnosis, patient selection for trials, and monitoring treatment response, while also highlighting the existing challenges.

Herantis Pharma is exploring extracellular vesicles and the NeuroSPARC platform to track disease biology and treatment impact, aiming for a broader biomarker profile rather than relying on a single marker.

Digital biomarkers from smartphones and wearables are seen as a complementary tool that can enable more efficient trials and more patient-tailored therapies, though they must be carefully distinguished from traditional biomarker tests.

Traditionally, neurology biomarkers relied on CSF obtained via lumbar puncture, but newer methods and sample types are expanding options beyond CSF.

Clinical trials illustrate the shift, with BioArctic’s exidavnemab and Amprion Diagnostics involved in phase 2 trials, as efforts continue to identify alpha-synuclein–positive patients.

The integration of digital biomarkers from devices provides frequent, real-world data on motor symptoms and progression, though validation against traditional clinical scores is needed.

There is a pivotal shift from invasive CSF-centric approaches to multi-modal biomarker strategies that combine blood tests, imaging, extracellular vesicles, seed amplification, and digital measurements to diagnose, monitor, and personalize treatment.

In Alzheimer's disease, blood-based biomarkers such as amyloid-beta and phosphorylated tau are enabling earlier and cheaper diagnosis and monitoring, aided by FDA-approved blood tests that improve accessibility.

For Parkinson’s, alpha-synuclein in CSF remains important but challenging; seed amplification assays are emerging to detect alpha-synuclein more reliably and help stratify patients in trials.