NCT06780917

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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jan 2025Jan 2029

First Submitted

Initial submission to the registry

January 7, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

January 7, 2025

Last Update Submit

March 6, 2026

Conditions

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

Keywords

Neuropsychological testingMild Cognitive ImpairmentOnline neuropsychological testingCognition

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Creyos Battery Administration

    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

    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

    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

Study Arms (3)

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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:
  • Aged 60 or older
  • Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
  • Having taken a cognitive enhancer within the past 6 weeks
  • Specific Eligibility Criteria for the rMDD Group:
  • 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
  • Having taken a cognitive enhancer within the past 6 weeks
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDepressive DisorderMood Disorders

Central Study Contacts

Benoit H. Mulsant, MD

CONTACT

416-583-1350benoit.mulsant@utoronto.ca

Heather Brooks, PhD

CONTACT

416-583-1350CreyosMD@camh.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Labatt Family Chair, Department of Psychiatry, University of Toronto; Senior Scientist, Centre for Addiction and Mental Health

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 17, 2025

Study Start

January 13, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

CA(3)