Mild Cognitive Impairment (MCI)Creyos-MDNCT06780917
Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment (MCI) and Major Depressive Disorder, Remitted, run by Centre for Addiction and Mental Health at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Major Depressive Disorder, Remitted, Healthy Controls Group - Age and Sex-matched
- How many people
- 150 participants
- Where
- 3 sitesCanada
- Study dates
- 13 Jan 2025to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Aged 60 or older
- Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
- 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
- Aged 60 or older
Who cannot join
- Having taken a cognitive enhancer within the past 6 weeks
- Specific Eligibility Criteria for the rMDD Group:
- 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:
- Meets DSM 5 criteria for MDD at anytime during their lifetime
- Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Lina Buelvas, Lina.Buelvas@unityhealth.to
Negah Sadighirad, Negah.SadighiRad@unityhealth.to
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Alastair Flint, MD
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Heather Brooks, 416-535-8501 ext. 33495, heather.brooks@camh.ca
Dewi Clark, 416-535-8501 ext. 30409, dewi.clark@camh.ca
About this study
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:
- 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).
- 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
- Keywords
- Neuropsychological testing, Mild Cognitive Impairment, Online neuropsychological testing, Cognition
- Medical subject headings
- Cognitive Dysfunction, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: In-person testing is completed yearly, and the Creyos online battery is complete quarterly, for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Jan 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Krembil Foundation
- Responsible party
- Principal investigator, Benoit Mulsant, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780917
- Sponsor's protocol ID
- 4912
- Acronym
- Creyos-MD
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06780917
- Acronym / sponsor ID
- Creyos-MD / 4912
- Conditions
- Mild Cognitive Impairment (MCI), Major Depressive Disorder, Remitted, Healthy Controls Group - Age and Sex-matched
- Keywords
- Neuropsychological testing, Mild Cognitive Impairment, Online neuropsychological testing, Cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Krembil Foundation
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Aged 60 or older
- Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
- 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
- Aged 60 or older
Key exclusion criteria (7 listed)
- Having taken a cognitive enhancer within the past 6 weeks
- Having taken a cognitive enhancer within the past 6 weeks
- Having received electroconvulsive therapy (ECT) within 6 months of baseline neuropsychological testing
- Meets DSM 5 criteria for MDD at anytime during their lifetime
- Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI) and Major Depressive Disorder, Remitted, run by Centre for Addiction and Mental Health at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit H. Mulsant, MD (416-583-1350, benoit.mulsant@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.