Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI), Major Depressive Disorder, Remitted, Healthy Controls Group - Age and Sex-matched. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Eligibility criteria
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")
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 3 centers
- St. Michael's Hospital — Toronto
- University Health Network — Toronto
- Centre for Addiction and Mental Health — Toronto
Identifiers
NCT: NCT06780917 · 4912