Validating an online cognitive assessment tool for older adults with cognitive issues
Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
This study is testing an online cognitive assessment tool to see if it can effectively help older adults with mild cognitive impairment or those recovering from depression track their brain health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT06780917 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Creyos online cognitive assessment platform specifically for older adults diagnosed with mild cognitive impairment (MCI) or those in remission from major depressive disorder (rMDD). Participants will undergo both in-person neuropsychological testing annually and complete the Creyos online battery quarterly over a period of up to five years. The study's objectives include assessing the feasibility of the online platform and determining its effectiveness in detecting cognitive changes compared to traditional testing methods. By comparing results from both assessment types, researchers hope to establish the reliability of the Creyos platform in monitoring cognitive health.
Who should consider this trial
Good fit: Ideal candidates include older adults aged 60 or older with a diagnosis of mild cognitive impairment or those in remission from major depressive disorder.
Not a fit: Patients with significant neurological conditions, unstable medical illnesses, or current depressive symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable online tool for monitoring cognitive health in older adults, potentially leading to earlier interventions.
How similar studies have performed: While the approach of using online cognitive assessments is gaining traction, this specific validation of the Creyos platform in this population is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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")
Where this trial is running
Toronto, Ontario and 2 other locations
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Benoit H. Mulsant, MD
- Email: benoit.mulsant@utoronto.ca
- Phone: 416-583-1350
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.