A Cohort Study on Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
MoCA Clinic and Institute
RECRUITING
Greenfield Park
Contact Information
Primary
Johanna Gruber, MSc
johanna.gruber@mocacognition.com
5147585033
Backup
Joanna Krieger
joana.krieger@mocacognition.com
450 672-7766
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2026-03-14
Participants
Target number of participants: 500
Treatments
Observational Cohort
The study population will include 500 patients that have been referred to the MoCA Clinic from the Greater Montreal Area. This includes individuals with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and mild dementia.~Participants complete cognitive tests, health and cognition questionnaires, and undergo a blood test for blood biomarker testing.
Paper MoCA Subgroup
Participants will be randomly assigned to complete either the paper MoCA or the digital MoCA Solo at Visit 1, with the other version completed at Visit 2. The Paper MoCA Subgroup will complete the paper MoCA at Visit 1.
MoCA Solo Subgroup
Participants will be randomly assigned to complete either the paper MoCA or the digital MoCA Solo at Visit 1, with the other version completed at Visit 2. The MoCA Solo Subgroup will complete the MoCA Solo at Visit 1.
Related Therapeutic Areas
Sponsors
Collaborators: C2N Diagnostics
Leads: MoCA Clinic and Institute

This content was sourced from clinicaltrials.gov