NCT07041450 Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
| NCT ID | NCT07041450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MoCA Clinic and Institute |
| Condition | Mild Cognitive Impairment |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2025-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-03-14 with a primary completion date of 2025-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Ziad Nasreddine, MD
PRINCIPAL INVESTIGATOR
MoCA Clinic
Frequently Asked Questions
Who can join the NCT07041450 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07041450 currently recruiting?
Yes, NCT07041450 is actively recruiting participants. Contact the research team at johanna.gruber@mocacognition.com for enrollment information.
Where is the NCT07041450 trial being conducted?
This trial is being conducted at Greenfield Park, Canada.
Who is sponsoring the NCT07041450 clinical trial?
NCT07041450 is sponsored by MoCA Clinic and Institute. The principal investigator is Ziad Nasreddine, MD at MoCA Clinic. The trial plans to enroll 500 participants.