Brain Stimulation + Cognitive Remediation for Preventing Alzheimer's

(PACt-MD Trial)

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: Antidepressants

Must not be taking: Anticonvulsants, Cognitive enhancers

Disqualifiers: Schizophrenia, Bipolar, OCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 50

375 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Benoit H Mulsant, MD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Mild Cognitive Impairment.

I am over 60 years old.

I am willing to sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive tDCS + CR or sham tDCS + sham CR 5 days a week for 8 weeks

8 weeks

40 visits (in-person)

Consolidation Treatment

Participants receive booster sessions of tDCS + CR or sham tDCS + sham CR for 5 days every 6 months

Every 6 months until study completion or development of dementia

10 visits (in-person or virtual) every 6 months

Follow-up

Participants are monitored for cognitive changes and development of dementia

7 years

Annual assessments (in-person or virtual)

Treatment Details

Interventions

• Cognitive Remediation
• tDCS

Trial Overview 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.

Participant Groups

Group I: tDCS + CR Experimental Treatment 1 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 CR Placebo Group 1 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).

Cognitive Remediation is already approved in European Union, United States for the following indications:

Approved in European Union as Cognitive Remediation for:

• Schizophrenia
• Forensic psychiatric rehabilitation

Approved in United States as Cognitive Remediation for:

• Schizophrenia
• Forensic psychiatric rehabilitation

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Queen's University

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Applied Health Research Centre

Collaborator

Trials

23

Recruited

70,900+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Baycrest Centre for Geriatric Care

Collaborator

Trials

5

Recruited

540+