Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based B
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 Montr
| Condition(s) | Mild Cognitive Impairment, Alzheimer Disease, Dementia |
|---|---|
| Status | Recruiting |
| 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-admi |
| Who can participate | 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 |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Lead sponsor | MoCA Clinic and Institute |
| Locations | Greenfield Park, Quebec, Canada |
| Start date | 2025-03-14 |
| NCT ID | NCT07041450 |
| Official listing | https://clinicaltrials.gov/study/NCT07041450 |