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Device

tDCS + Cognitive Training for Alzheimer's Disease

N/A

Recruiting

Led By John R McCarten, MD

Research Sponsored by Minneapolis Veterans Affairs Medical Center

Eligibility Criteria Checklist

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

Must have

Participants demonstrating capacity to provide informed consent

Participants aged 60 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and 3 week follow-up; 3 and 6 months following study baseline

Summary

This trial proposes a new treatment for early Alzheimer's that combines electrical stimulation with cognitive training to improve brain function & cognition.

Who is the study for?

This trial is for people aged 60 or older with early Alzheimer's disease (AD), mild cognitive impairment (MCI), or Mild Neurocognitive Disorder. They must be stable on medications, able to consent, have WiFi at home, and a care partner available for support. It excludes those with significant medical risks, other psychiatric/neurological conditions affecting cognition, scalp issues that could react to stimulation, or metal in the head.

What is being tested?

The study tests if brain stimulation called tDCS can improve thinking and brain function in patients with MCI and early AD. Participants will receive either active tDCS or a sham (fake) treatment alongside cognitive training exercises designed to boost executive functions.

What are the potential side effects?

tDCS may cause discomfort at the site of application on the scalp like itching or tingling during treatment. There might also be fatigue or headaches after sessions but these are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the details of the clinical trial and can consent to participate.

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I am 60 years old or older.

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I have been diagnosed with early Alzheimer's or mild cognitive impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and 3 week follow-up; 3 and 6 months following study baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and 3 week follow-up; 3 and 6 months following study baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and 3 week follow-up; 3 and 6 months following study 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 Brief Test of Adult Cognition by Telephone (BTACT)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).

Group II: Sham tDCSPlacebo Group1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This ramp up/down method is done at the end of the stimulation period, as well. This method mimics the physical sensation of stimulation typically encountered at the very beginning and end of the intervention period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Transcranial Direct Current Stimulation (tDCS)

2020

N/A

~160

0 / 3Eligibility criteria met