Biomarkers

Alzheimers Dement. 2024 Dec:20 Suppl 2:e092164. doi: 10.1002/alz.092164.

Abstract

Background: Many outcome measures used in AD clinical trials require clinic visits and are paper based, making them infrequent and burdensome 'snapshots', subject to rater bias. A consortium of 10 pharma companies came together with Cumulus Neuroscience to design a solution for frequent, objective, real-world measurement across a range of domains. We present a study that examined the feasibility of asking patients with mild dementia to use the neuroassessment platform repeatedly at home for one year.

Method: Seven UK sites recruited Alzheimer's type mild dementia patients (n=59, ACE-III scores >60 and ≤88) and a matched cohort of controls (n=60). Participants had 2 weeks of at-home familiarisation to become comfortable with the 8 assessments presented on a mobile tablet and EEG headsets, one for wake and another for sleep. A staggered longitudinal protocol followed, with burst sampling tapering to periodic sampling over the year. Benchmark paper-based assessments (including ADAS-Cog) and self-reported usability were collected at months 0, 6 and 12. Additionally, plasma was collected at months 6 and 12 for later biomarker analysis.

Result: Feedback collected at baseline showed differences in technology usage. Patients felt they required more technology support than controls (49% vs 17%). Nonetheless, they were successful in using the study technology at home on a regular basis and maintained a high level of adherence to the protocol. Overall compliance was 76.3% for dementia, 88.4% for controls and was highest in the latter stages of the study during periodic sampling (Stage 4 during wake EEG sessions: 80.8% dementia, 93.9% controls). System Usability Scale results indicated controls rated usability higher (63.8) than dementia participants (54.5) at baseline, increasing for both groups by Week 52 (74.4 controls; 58.3 dementia).

Conclusion: With appropriate technology design, and provision of training and support, patients with Alzheimer's disease dementia are capable and willing to provide repeated, real-world samples of a broad range of objective digital endpoints for clinical research.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alzheimer Disease*
  • Biomarkers* / blood
  • Electroencephalography
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • United Kingdom

Substances

  • Biomarkers