Recruiting

Alzheimer's Diagnostic Solution

Sponsor:

MoCA Clinic and Institute

Code:

NCT07041450

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Dementia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Digital MoCA

XpressO

MoCA

Blood-based Biomarkers (BBM)

Amyloid Treatment Screening Tool (ATST)

Study Details

Brief 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

Study ID

NCT07041450

Start date

Mar 14, 2025

Status verified date

Jun, 2025

Completion date

Mar 14, 2026

Anticipated

Primary completion date

Dec 14, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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).

XpressO

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

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.

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)

Amyloid Treatment Screening Tool (ATST)

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

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.

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.

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.

Primary outcome measure

  • Time to diagnosis [ Time Frame: From enrollment to 6-month follow-up ]

Central Contacts and Locations

Central contacts

Johanna Gruber, MSc

5147585033johanna.gruber@mocacognition.com

Joanna Krieger

450 672-7766joana.krieger@mocacognition.com

Locations

MoCA Clinic and Institute

Recruiting

Greenfield Park, Quebec, Canada, J4V 2J2

Contacts

Joana Krieger

450 672-7766joana.krieger@mocacognition.com

Amy Dam

amy.dam@mocacognition.com

More Information

Sponsor

MoCA Clinic and Institute

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Keywords

  • blood-based biomarkers
  • digital cognitive assessment
  • diagnostic screening
  • MoCA
  • disease-modifying therapy
  • older adults
  • early detection
  • Montreal Cognitive Assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MoCA Clinic and Institute on 2025-07-01.