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

Summary

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.

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease
• Dementia

Interventions

DIAGNOSTIC_TEST

Digital MoCA

A digital version of the Montreal Cognitive Assessment used to evaluate cognitive function. Administered on a tablet at Visit 1 or Visit 2 (randomized).

DIAGNOSTIC_TEST

XpressO

A digital cognitive pre-screening tool used to screen for cognitive function. Administered on a tablet at Visit 1.

DIAGNOSTIC_TEST

MoCA

The standard paper-baed Montreal Cognitive Assessment used to evaluate cognitive function. Administered at Visit 1 or Visit 2 (randomized), opposite the digital MoCA.

DIAGNOSTIC_TEST

Blood-based Biomarkers (BBM)

Participants provide a blood sample that is analyzed for Alzheimer's disease-related biomarkers, including PrecivityAD2 and MTBR. These biomarkers are used to assess the biological stage of disease and support diagnostic triage and eligibility assessment for disease-modifying therapy (DMT)

OTHER

Amyloid Treatment Screening Tool (ATST)

A questionnaire administered to assess eligibility for amyloid-targeted therapies. Both clinician and patient-centered versions are used.

OTHER

MoCA Brain Health Questionnaire (MBHQ)

A questionnaire designed to capture participants' physical health, emotional well-being, diet, exercise, and social engagement as it relates to cognitive health. Responses are used as part of exploratory analyses to evaluate associations with cognitive status and Alzheimer's disease diagnosis.

OTHER

MoCA Medical Questionnaire

A structured questionnaire administered to participants to gather information on their medical history, including prior diagnoses, medications, and other health conditions. This data helps to contextualize cognitive symptoms and support diagnostic decision-making in the study.

OTHER

Functional Activities Questionnaire+ (FAQ+)

A questionnaire designed to assess the participant's ability to perform daily activities, providing insights into their functional status and cognitive impairment. It is a longer version of the original FAQ questionnaire. It is used as part of the screening and exploratory analysis to better understand the relationship between functional abilities and Alzheimer's disease progression.

Sponsors & Collaborators

• C2N Diagnostics

  collaborator INDUSTRY

• MoCA Clinic and Institute

  lead OTHER

Principal Investigators

• Ziad Nasreddine, MD · MoCA Clinic

Eligibility

Min Age

55 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-14

Primary Completion

2025-12-14

Completion

2026-03-14

Countries

• Canada

Study Locations