🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Canada / NCT02386670
Active, not recruiting Not applicable

Prevention of Alzheimer's Disease With CR Plus tDCS in Mild Cognitive Impairment and Depression (PACt-MD)

NCT02386670 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2015-01
Last updated
2026-04-09

Condition(s) studied

Mild Cognitive ImpairmentMajor Depressive Disorder, Recurrent, In RemissionMajor Depressive Disorder, Single Episode, in Full Remission

Investigational drug(s) / intervention(s)

tDCS + CRsham tDCS + sham CR

tDCS + CR: First, the intervention sessions will be administered 5 days/week for 8 weeks (induction phase). Then, for 5 days once every 6 months (consolidation phase). tDCS session: anode over Fz \& cathode over Iz; direct current: 2 mA (current density=0.57A/m2) for 30 min. at the beginning of each group session. Cognitive Remediation (CR) will also be administered. Sessions last 2 hours each day in a group supervised by trained interventionists. Participants will also complete CR exercises online at home. CR will consist of computer-based exercises relevant to attention, processing speed, executive function, and verbal and working memory with titrated difficulty levels. Performance feedback will reinforce progress. "Strategic monitoring and bridging discussions" will promote transfer of cognitive gains to everyday tasks. During COVID-19, booster sessions can be provided either in-person or virtually (except for tDCS that cannot be done remotely).

sham tDCS + sham CR: First, the intervention sessions will be administered 5 days/week for 8 weeks (induction phase). Then, for 5 days once every 6 months (consolidation phase). tDCS session: anode over Fz \& cathode over Iz; direct current: 2 mA (current density=0.57A/m2) for 1 minute, then the current will be 0 mA for 29 minutes at the beginning of each group session. Cognitive Remediation (CR) will also be administered. Sessions last 2 hours each day in a group supervised by trained interventionists. Participants will also complete CR exercises online at home. CR will consist of computer-based exercises relevant to attention, processing speed, executive function, and verbal and working memory without titrated difficulty levels. During COVID-19, booster sessions can be provided either in-person or virtually (except for sham tDCS that cannot be done remotely).

Study summary

This 7-year randomized controlled trial will compare the efficacy of non-invasive brain stimulation (trans-cranial Direct Current Stimulation - tDCS) combined with cognitive remediation (CR) versus sham ("placebo") tDCS combined with sham ("placebo") CR in slowing down cognitive decline and preventing Alzheimer's Dementia in older persons with mild cognitive impairment or major depressive disorder with or without mild cognitive impairment.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
MCI Group Inclusion: * Age \> 60 (on day of randomization) * DSM 5 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: * Met DSM 5 criteria for Major Depressive Episode in past 10 years * Lifetime DSM 5 diagnosis of schizophrenia, bipolar disorder, or OCD * DSM 5 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 exceptions below) that cannot be safely tapered and discontinued. The following psychotropic medications are allowed: i) any antidepressant; ii) zopiclone, trazadone, or a benzodiazepine if they have been taken at a stable dose for at least 4 weeks prior to study entry and; iii) gabapentin and pregabalin if they have been taken at a stable dose for at least 4 weeks prior to study entry AND if prescribed for chronic pain. * A pace-maker or other metal implants that would preclude safe use of tDCS. MDD Group Inclusion: * Age ≥ 65 (on day of randomization) * Meets DSM 5 criteria for one or more MDE(s)with: 1. an offset of 2 months to 5 years from the screening visit date. It is not necessary for this (these) episode(s) to have received medical attention OR 2. an offset of 5 years or more from the screening visit date. It is necessary that at least one MDE received medical attention (e.g., previously been on one or more antidepressant(s), saw a psychiatrist, primary care physician, or had a previous hospitalization). Also, the MDE must have occurred during the participant's adult life (i.e., at 18 years of age or older). * MADRS score of 10 or below * Willingness to provide informed consent * 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: * Meets DSM 5 criteria for Major Neurocognitive Disorder ("dementia") * Lifetime DSM 5 diagnosis of schizophrenia, bipolar disorder, or OCD * DSM 5 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) * Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. In addition to any antidepressant, 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, trazodone, or a benzodiazepine; and gabapentin or pregabalin if prescribed for chronic pain. * Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks. * A pace-maker or other metal implants that would preclude safe use of tDCS. * Received electroconvulsive therapy (ECT) within 6 months of baseline neruopsychological testing. Control group Inclusion: * Age \> 60 * MADRS score of 10 or below * Willingness to provide informed consent * Ability to read and communicate in English (with corrected vision and hearing, if needed) Exclusion: * Meets DSM 5 criteria for Minor or Major Neurocognitive Disorder * Any other lifetime DSM 5 diagnosis except for simple/specific phobias * Significant neurological condition (e.g., stroke, seizure disorder, MS) * Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension) * 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: zopiclone up to 15 mg/day; trazadone up to 150 mg/day; benzodiazepine at a dose of up to 3 mg/day lorazepam-equivalents; gabapentin and pregabalin (if prescribed for pain). * A pace-maker or other metal implants * Neuropsychological testing within the past 12 months

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Baycrest Centre for Geriatric Care Toronto Ontario
Centre for Addiction and Mental Health Toronto Ontario
St. Michael's Hospital Toronto Ontario
Sunnybrook Heath Sciences Centre Toronto Ontario
University Health Network Toronto Ontario

More Centre for Addiction and Mental Health trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02386670 on ClinicalTrials.gov ↗ ← All trials in Canada