Active — Not RecruitingNot Applicable

Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression

Canada40 participantsStarted 2016-10-31

Plain-language summary

The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. Age \> 60 (on day of randomization)
✓. DSM-IV criteria for Mild Neurocognitive Disorder ("MCI")
✓. Willingness to provide informed consent
✓. MADRS score of 10 or below
✓. Availability of a study partner who has regular contact with the participant
✓. Ability to read and communicate in English (with corrected vision and hearing, if needed)

Exclusion criteria

✕. Met DSM-IV criteria for Major Depressive Episode in past 10 years
✕. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
✕. DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months
✕. High risk for suicide
✕. Significant neurological condition (e.g., stroke, seizure disorder, MS)
✕. Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension)
✕. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks
✕. Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. The following psychotropic medications are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry: zopiclone, trazadone, or a benzodiazepine; gabapentin, pregabalin, duloxetine, venlafaxine, or low-dose tricyclic antidepressants if prescribed for chronic pain.

What they're measuring

Feasibility of training a facilitator (caregiver) to facilitate the administration of CR+tDCS to their "patient" partner as indicated by a positive response in the Perceived Competence Scale at 24 months from study baseline.

Timeframe: Approximately 24 months after baseline

Fidelity to delivering home-based CR+tDCS by a facilitator (caregiver) to the participant as indicated by the compliance rate during the induction phase and boosters.

Timeframe: Baseline and approximately 24 months after baseline

Trial details

NCT IDNCT02959502

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-23

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