Actively Recruiting

Age: 55Years - 90Years
All Genders
NCT07041450

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

Led by MoCA Clinic and Institute · Updated on 2025-07-01

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

M

MoCA Clinic and Institute

Lead Sponsor

C

C2N Diagnostics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 55Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be referred to the MoCA Clinic, including new patients and existing patients seen more than 1 year ago
  • Have cognitive impairment or complaints about cognition
  • Be able to understand the study purpose and risks and give informed consent
  • Have a study partner who knows the participant well, can provide accurate information, be available by phone, and attend one in-person visit
  • The study partner should be available for the entire duration of the study
Not Eligible

You will not qualify if you...

  • Have a known diagnosis other than Alzheimer's disease causing cognitive impairment (e.g., substance abuse, cerebrovascular disease, Lewy body dementia, fronto-temporal dementia, recent head trauma)
  • Donated one unit of blood within 1 month before screening
  • Unable to complete essential study components due to issues like severe visual impairment or kidney disease
  • Currently enrolled in another Alzheimer's disease clinical trial at screening
  • Other reasons deemed unsuitable by the Principal Investigator or MoCA Clinic staff

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MoCA Clinic and Institute

Greenfield Park, Quebec, Canada, J4V 2J2

Actively Recruiting

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Research Team

J

Johanna Gruber, MSc

CONTACT

J

Joanna Krieger

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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