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Brain Stimulation + Cognitive Remediation for Preventing Alzheimer's (PACt-MD Trial)

N/A

Waitlist Available

Led By Benoit H Mulsant, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4, 12, 24, 36, 48, 60 months after baseline

Summary

This trial will compare the efficacy of a non-invasive brain stimulation combined with cognitive remediation versus a sham ("placebo") stimulation combined with a sham ("placebo") cognitive remediation 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.

Who is the study for?

This trial is for older adults over 60 who've had depression or a major depressive episode in the past decade. They must have mild cognitive impairment (MCI) or be stable with no recent substance abuse issues. A study partner is required, and participants need to understand English.

What is being tested?

The study tests if brain stimulation (tDCS) combined with mental exercises (CR) can slow down memory loss and prevent Alzheimer's compared to placebo treatments, over a period of seven years.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the head, headache, fatigue, nausea, or itching under the electrodes used for tDCS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4, 12, 24, 36, 48, 60 months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4, 12, 24, 36, 48, 60 months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4, 12, 24, 36, 48, 60 months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cognitive scores over time

Secondary study objectives

Percentage of subjects who remain free of MCI or dementia over time

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: tDCS + CRExperimental Treatment1 Intervention

Intervention sessions are administered 5 days/week for 8 weeks (induction phase). Then, for 5 days every 6 months (consolidation phase).Transcranial Direct Current Stimulation (tDCS) session: anode over Fz \& cathode over Iz; direct current: 2 mA (current density=0.57A/m2) for 30 minutes/session 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 also complete CR exercises online at home. CR consists 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" promotes 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).

Group II: sham tDCS + sham CRPlacebo Group1 Intervention

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).

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