Technology is already being used in clinical trials of new treatments for Alzheimer’s and new studies will provide additional validation

Cumulus Neuroscience has announced the beginning of new clinical studies to investigate the company’s digital biomarker in quantifying cognitive decline over time, in patients with conditions such as dementia and Alzheimer’s disease.

Previous field-testing with dementia patients has shown that Cumulus’ platform is suitable for at-home use and so these studies are a great opportunity to assess its potential in providing more precise, longitudinal measures of cognitive decline. The technology is already being used in clinical trials of new treatments for Alzheimer’s and these studies will provide additional validation of its sensitivity to change over time.

Cumulus has created a single digital platform, accessible via a hand-held tablet device and time-linked to a functional EEG measure of brain activity. The platform combines these measurements with advanced AI and data analytics techniques.

The UK multi-site CNS-101 study will assess the feasibility of using repeated digital measures at the homes of patients with early-stage AD dementia, compared with healthy controls. 120 participants will use the platform over the course of one year and data will be compared with standard assessments typically used in AD dementia clinical trials.

Brian Murphy, Cumulus Neuroscience’s CSO, explained: “Current standard measurement tools for dementia, such as clinician administered scales, only give a snapshot in an atypical environment and can suffer from day-to-day variation and other measurement errors. As such, they limit the precision and ability to measure an effect in current CNS clinical trials.

Dr Kinan Muhammed, chief investigator of the CNS-101 study, added: “We’re pleased to be working with Cumulus to investigate ways to improve measurement in these devastating diseases. The platform is specifically designed to address several key parameters in the assessment of CNS disease progression. The frequent at-home approach to sampling data is intended to lower patient burden and could improve the sensitivity and success rate for future clinical trials in dementia.”