NCT07041450Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 7 May 2025
- Start date
- 14 Mar 2025
- Primary completion date
- 14 Dec 2025
- Lead sponsor
- MoCA Clinic and Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT07041450
What you commit to
- Study type: Observational
- Planned participants: 500
- From 14 Mar 2025 to the primary completion date, 14 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood donation (1 unit) within 1 month prior to Study screening.
Other illness
- 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).
- Inability to comply with requirements to complete essential components of the Study (e.g. visual impairment, severe kidney disease or ongoing kidney treatment)
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MoCA Clinic and Institute Coordinator of this site? Confirm its status | Greenfield Park | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.