Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

Recruiting

• Conditions: Mild Cognitive Impairment (MCI); Major Depressive Disorder, Remitted; Healthy Controls Group - Age and Sex-matched

• Registration Number: NCT06780917
• Lead Sponsor: Centre for Addiction and Mental Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Study Start: 2026-01
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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")

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Creyos Battery Administration	Upon completion of the Creyos online cognitive platform, approximately every three months, for up to 5 years	To determine the feasibility of administering the Creyos online cognitive platform in individuals with MCI and major depressive disorder in remission, participants will complete two questionnaires after every completion of the Creyos battery. Participants will be asked to complete the System Usability Scale (10 items). Scores on the System Usability Scale range from 0 to 100, with higher scores indicating greater usability. We will look at the total score to determine how easy the participants find the Creyos online cognitive platform to use, and if usability increases with exposure to the platform.
Feasibility of the Creyos Battery	Upon completion of the Creyos online cognitive platform, approximately every three months, for up to 5 years	To determine the feasibility of administering the Creyos online cognitive platform in individuals with MCI and major depressive disorder in remission, participants will complete two questionnaires after every completion of the Creyos battery. Participants will be asked to complete the User Burden Scale (20 items). Scores on the User Burden Scale range from 0 to 80, with higher scores indicating greater user burden. We will look at the total score to determine how easy the participants find the Creyos online cognitive platform to use, and if usability increases with exposure to the platform.
Validity of the Creyos Platform	In-person testing is completed yearly, and the Creyos online battery is complete quarterly, for up to 5 years	To determine the validity of the Creyos online platform, we will compare the single test scores, domain composite scores and global composite scores between the in-person paper-and-pencil neuropsychological tests ("gold standard") and the Creyos online battery.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada