Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers

This study evaluates a diagnostic screening solution for Alzheimer's disease (AD) using digital cognitive assessments and blood-based biomarkers. The aim is to reduce time-to-treatment for patients who may benefit from disease-modifying therapy (DMT). The study involves 500 patients referred to the MoCA Clinic in Montreal. Clinical stages will be assessed using digital tools from MoCA Test Inc. (MoCA Cognition), and biological stages via blood biomarkers. Data collected includes demographics, cognitive scores, health questionnaires, biomarker levels, and neurologist-determined eligibility for DMT. The study will result in an algorithm to support diagnostic triage and estimate the efficiency and equity of a fast-track diagnostic pathway. Exploratory endpoints include validation of self-administered digital tools, health-economic estimates, and predictors of cognitive decline.

NCT Number	NCT07041450
Lead Sponsor	MoCA Clinic and Institute Collaborators: C2N Diagnostics
Conditions	Mild Cognitive Impairment, Alzheimer Disease, Dementia
Enrollment	500 participants
Start Date	2025-03-14
Primary Completion	2025-12-14 (estimated)
Study Completion	2026-03-14 (estimated)
Updated on ClinicalTrials.gov	2025-07-01