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NCT Number: NCT06780917

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

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Depressive Disorder Depressive Disorder, Major Healthy Controls Group - Age and Sex-matched Major Depressive Disorder, Remitted Mental Disorders Mood Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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")

Treatment and study plan

Primary outcomes

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.
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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit H. Mulsant, MD

CONTACT

[email protected]

416-583-1350

Heather Brooks, PhD

CONTACT

[email protected]

416-583-1350

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

Krembil Foundation

Registry information

Acronym: Creyos-MD

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jan 17, 2025
Registry last updated: Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed