NCT06780917 Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
| NCT ID | NCT06780917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Mild Cognitive Impairment (MCI) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2029-01 |
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 150 participants in total. It began in 2025-01-13 with a primary completion date of 2029-01.
⚠ 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
The goal of this observational study is to validate the Creyos online cognitive assessment platform in individuals with mild cognitive impairment, or remitted major depressive disorder. The main objectives of this research are: 1. To confirm the feasibility of administering the Creyos cognitive battery to older adults with Mild Cognitive Impairment MCI) or Major Depressive Disorder in remission (rMDD). 2. To determine whether the Creyos battery can detect changes in cognition that are predictive of changes on paper-and-pencil neuropsychological testing ("gold standard") over up to five years. Participants will complete both in-person neuropsychological testing yearly as well as the Creyos online battery quarterly for up to 5 years, to allow us to compare performance on these two batteries over time.
Eligibility Criteria
General Inclusion Criteria: * Ability to read and communicate in English * Availability of a study partner who has regular contact with the participant General Exclusion Criteria: * Lifetime DSM 5 diagnosis of schizophrenia, bipolar disorder, or OCD * DSM 5 diagnosis of alcohol or other substance use disorder within the past 12 months * High risk for suicide * Significant neurological conditions (e.g. stroke, seizure disorder, MS) * Unstable medical illnesses (e.g. uncontrolled diabetes mellitus or hypertension) * Taking anticonvulsants or other psychotropic medication that may interfere with cognitive testing that cannot be safely tapered and discontinued * Current depressive symptoms defined as a MADRS score of 10 or above Specific Eligibility Criteria for the MCI Group: Inclusion: * Aged 60 or older * Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI") Exclusion: * Having taken a cognitive enhancer within the past 6 weeks Specific Eligibility Criteria for the rMDD Group: Inclusion: * Aged 65 or older * Meets DSM 5 criteria for one or more major depressive episode(s) (MDE) during their adult life (i.e. 18 years of age or older) with: (a) an offset of 2 months to 5 years from the screening visit date, or (b) an offset of 5 years or more, with at least one MDE receiving medical attention (e.g. previously been on an antidepressant, saw a psychiatrist, primary care physician, or had a previous hospitalization Exclusion: * Having taken a cognitive enhancer within the past 6 weeks * Having received electroconvulsive therapy (ECT) within 6 months of baseline neuropsychological testing Specific Eligibility Criteria for the Control Group: Inclusion: * Aged 60 or older Exclusion: * Meets DSM 5 criteria for MDD at anytime during their lifetime * Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06780917 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mild Cognitive Impairment (MCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780917 currently recruiting?
Yes, NCT06780917 is actively recruiting participants. Contact the research team at benoit.mulsant@utoronto.ca for enrollment information.
Where is the NCT06780917 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT06780917 clinical trial?
NCT06780917 is sponsored by Centre for Addiction and Mental Health. The trial plans to enroll 150 participants.