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

Recruiting now

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease, Dementia

In brief

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.

Key facts

Study ID

NCT07041450

Run by

MoCA Clinic and Institute

People needed

500

Starts

2025-03-14

Expected to finish

2026-03-14

Last updated by the study team

2025-07-01

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be referred to the MoCA Clinic; including both new patients and existing patients who have been seen >1 year ago
• Present with cognitive impairment or cognitive complaints.
• Must have the ability to understand the purpose and risk of the Study and provide informed consent.
• Must have an identified study partner (informant/care partner), who has frequent and sufficient contact with the participant to be able to provide accurate information about the participant's cognitive and functional abilities. The study partner must be available by phone to provide information to the study staff about the participant and agrees to attend one in-person visit at the MoCA Clinic which requires partner input. The study partner should be available for the duration of the study.

You may not qualify if…

• An established diagnosis (other than AD), that is a cause for a candidate's cognitive impairment (e.g. substance abuse, cerebrovascular conditions, Lewy body dementia, fronto-temporal dementia, recent head trauma).
• Blood donation (1 unit) within 1 month prior to Study screening.
• Inability to comply with requirements to complete essential components of the Study (e.g. visual impairment, severe kidney disease or ongoing kidney treatment)
• Patients already enrolled in any clinical trial for AD at time of Study screening
• Other unspecified reasons that, in the opinion of the Principal Investigator, or MoCA Clinic and Institute, make the candidate unsuitable for enrolment.

Where it is running

• MoCA Clinic and Institute — Greenfield Park, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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