Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
A Cohort Study on Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2025
CompletedFirst Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2026
CompletedJuly 1, 2025
June 1, 2025
9 months
May 7, 2025
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to diagnosis
The primary outcome metric is the time to diagnosis for patients that are eligible vs. not eligible for anti-amyloid medication. In this case, time to diagnosis is defined by the time it takes to determine if patient is eligible anti-amyloid medication or not.
From enrollment to 6-month follow-up
Secondary Outcomes (1)
Benefit of Diagnostic Screening
Baseline to 6-month follow-up
Other Outcomes (10)
Validation of MoCA Solo compared to MOCA paper test
Baseline (Visit 1) to 3 months (Visit 2)
Evaluation of MoCA Solo as diagnostic digital biomarker within BBM algorithm
Baseline to 6-month follow-up
Accuracy, specificity, and sensitivity of XpressO as compared to the diagnosis of a neurologist.
Baseline
- +7 more other outcomes
Study Arms (3)
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
A digital version of the Montreal Cognitive Assessment used to evaluate cognitive function. Administered on a tablet at Visit 1 or Visit 2 (randomized).
A digital cognitive pre-screening tool used to screen for cognitive function. Administered on a tablet at Visit 1.
The standard paper-baed Montreal Cognitive Assessment used to evaluate cognitive function. Administered at Visit 1 or Visit 2 (randomized), opposite the digital MoCA.
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)
A questionnaire administered to assess eligibility for amyloid-targeted therapies. Both clinician and patient-centered versions are used.
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.
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.
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.
Eligibility Criteria
The study population will include 500 patients that have been referred to the MoCA Clinic from the Greater Montreal Area. There will be a mix of English and French speaking with approximately 80% having French as a first language.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MoCA Clinic and Institutelead
- C2N Diagnosticscollaborator
Study Sites (1)
MoCA Clinic and Institute
Greenfield Park, Quebec, J4V 2J2, Canada
Related Publications (1)
Klil-Drori S, Bodenstein KC, Sun S, Kojok L, Gruber J, Ghantous Y, Cummings J, Nasreddine Z. Montreal Cognitive Assessment (MoCA) XpressO: Validation of a digital self-administered cognitive prescreening tool. J Am Geriatr Soc. 2024 Aug;72(8):2516-2522. doi: 10.1111/jgs.18902. Epub 2024 Apr 1.
PMID: 38558263BACKGROUND
Biospecimen
Participants consent for optional storage of 14ml of blood plasma for future biomarker and genetic analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Nasreddine, MD
MoCA Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2025
First Posted
June 27, 2025
Study Start
March 14, 2025
Primary Completion
December 14, 2025
Study Completion
March 14, 2026
Last Updated
July 1, 2025
Record last verified: 2025-06