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

NCT ID: NCT06780917

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-01-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MCI

Individuals diagnosed with Mild Cognitive Impairment

No interventions assigned to this group

Major Depressive Disorder in remission

Individuals with major depressive disorder in remission, with no active symptoms of depression

No interventions assigned to this group

Control participants

Individuals with no history of psychiatric illness, not currently taking any psychotropic medications

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ability to read and communicate in English
* Availability of a study partner who has regular contact with the participant

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")
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krembil Foundation

UNKNOWN

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Benoit Mulsant

Professor, Labatt Family Chair, Department of Psychiatry, University of Toronto; Senior Scientist, Centre for Addiction and Mental Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Benoit H. Mulsant, MD

Role: CONTACT

416-535-8501 ext. 4749

Heather Brooks, PhD

Role: CONTACT

416-535-8501 ext. 33495

Facility Contacts

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Heather Brooks

Role: primary

416-535-8501 ext. 33495

Dewi Clark

Role: backup

416-535-8501 ext. 30409

Other Identifiers

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4912

Identifier Type: -

Identifier Source: org_study_id

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