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

March 6, 2026 updated by: Benoit Mulsant, Centre for Addiction and Mental Health

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
        • Principal Investigator:
          • Alastair Flint, MD
      • Toronto, Ontario, Canada, M6J 1H4
        • Recruiting
        • Centre for Addiction and Mental Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benoit H. Mulsant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

We will recruit participants with MCI, rMDD or controls in Toronto, Ontario, Canada who are available to come to the Centre for Addiction and Mental Health once per year for up to 5 years for in-person assessments

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MCI
Individuals diagnosed with Mild Cognitive Impairment
Major Depressive Disorder in remission
Individuals with major depressive disorder in remission, with no active symptoms of depression
Control participants
Individuals with no history of psychiatric illness, not currently taking any psychotropic medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Creyos Battery Administration
Time Frame: 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.
Upon completion of the Creyos online cognitive platform, approximately every three months, for up to 5 years
Feasibility of the Creyos Battery
Time Frame: 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.
Upon completion of the Creyos online cognitive platform, approximately every three months, for up to 5 years
Validity of the Creyos Platform
Time Frame: 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.
In-person testing is completed yearly, and the Creyos online battery is complete quarterly, for up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Krembil Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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