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
MoCA Clinic and Institute
500 participants
Mar 14, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07041450