Recruiting

Cognitive Assessment

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06780917

Conditions

Mild Cognitive Impairment (MCI)

Major Depressive Disorder, Remitted

Healthy Controls Group - Age and Sex-matched

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Mild Cognitive Impairment (MCI)

Major Depressive Disorder, Remitted

Healthy Controls Group - Age and Sex-matched

Study ID

NCT06780917

Start date

Jan 13, 2025

Status verified date

Mar, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Feasibility of Creyos Battery Administration [ Time Frame: 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Benoit H. Mulsant, MD

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

Heather Brooks, PhD

416-583-1350CreyosMD@camh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Lina Buelvas

Lina.Buelvas@unityhealth.to

Negah Sadighirad

Negah.SadighiRad@unityhealth.to

Principal Investigator:

Corinne Fischer, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Alastair Flint, MD

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Heather Brooks

416-535-8501heather.brooks@camh.ca

Dewi Clark

416-535-8501dewi.clark@camh.ca

Principal Investigator:

Benoit H. Mulsant

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Keywords

  • Neuropsychological testing
  • Mild Cognitive Impairment
  • Online neuropsychological testing
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-10.