NCT06780917 · RECRUITING
Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
This observational study checks whether Creyos, an online set of brain-skill tests, can track changes in thinking over time as well as traditional paper-and-pencil testing. Participants take the online tests quarterly and in-person tests yearly, for up to five years. Nothing is being given or treated. It is a validation study, not a drug trial, and no phase applies.
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")The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-10