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

RecruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

March 14, 2025

Primary Completion Date

December 14, 2025

Study Completion Date

March 14, 2026

Conditions
Mild Cognitive ImpairmentAlzheimer DiseaseDementia
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.

Trial Locations (1)

J4V 2J2

RECRUITING

MoCA Clinic and Institute, Greenfield Park

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

C2N Diagnostics

INDUSTRY

lead

MoCA Clinic and Institute

OTHER

NCT07041450 - Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers | Biotech Hunter | Biotech Hunter