Fast-track screening to determine eligibility for anti-amyloid treatment using digital cognitive tests and blood biomarkers.
A Cohort Study on Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
MoCA Clinic and Institute · NCT07041450
This project will test whether combining self‑administered digital cognitive tests with blood biomarker results can quickly identify patients referred for memory concerns who may qualify for anti‑amyloid disease‑modifying therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | MoCA Clinic and Institute (other) |
| Locations | 1 site (Greenfield Park, Quebec) |
| Trial ID | NCT07041450 on ClinicalTrials.gov |
What this trial studies
Up to 500 patients referred to the MoCA Clinic with cognitive complaints will complete digital cognitive screening (MoCA Cognition/XpressO) and provide blood samples for biomarker assays (including PrecivityAD2 and MTBR). Demographics, health questionnaires, cognitive scores, biomarker levels, and neurologist determinations of DMT eligibility will be collected. Data will be used to build an algorithm to triage patients into a fast‑track diagnostic pathway and to estimate follow‑up testing needs (MRI, PET, CSF). Exploratory analyses will validate self‑administered tools, estimate health‑economic impacts, and identify predictors of cognitive decline.
Who should consider this trial
Good fit: Adults referred to the MoCA Clinic with cognitive complaints or mild cognitive impairment who can give informed consent and have an available study partner are ideal candidates.
Not a fit: Patients with an established non‑Alzheimer cause of cognitive impairment or those unable to consent or provide a study partner are unlikely to benefit from this screening pathway.
Why it matters
Potential benefit: If successful, this approach could shorten the time from referral to treatment for patients who qualify for anti‑amyloid disease‑modifying therapies.
How similar studies have performed: Previous research shows blood‑based biomarkers and digital cognitive tests can predict amyloid status and decline, but combining them into a validated fast‑track triage algorithm is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Greenfield Park, Quebec
- MoCA Clinic and Institute — Greenfield Park, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Ziad Nasreddine, MD — MoCA Clinic
- Study coordinator: Johanna Gruber, MSc
- Email: johanna.gruber@mocacognition.com
- Phone: 5147585033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Cognitive Impairment, Alzheimer Disease, Dementia, blood-based biomarkers, digital cognitive assessment, diagnostic screening, MoCA, disease-modifying therapy