Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
Recruiting · NCT07041450 · Observational (researchers observe without assigning treatment) · Lead sponsor: MoCA Clinic and Institute
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
1 location listed.
- MoCA Clinic and Institute - Greenfield Park, Quebec, Canada