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Device

tDCS for Alzheimer's Disease (NICE-AD Trial)

N/A

Recruiting

Led By Joe Verghese, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

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

Must have

Able to speak and understand English or Spanish at a level sufficient to undergo the study procedures and testing protocols

AD diagnosed by neurologists or geriatricians at our dementia and geriatric clinical sites

Must not have

History of head trauma, seizures, brain surgery, stroke, or cancer affecting head

Unstable medical or major psychiatric illnesses or unstable treatments for medical or major psychiatric illnesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).

Summary

This trial will determine if transcranial Direct Current Stimulation (tDCS) can improve cognitive performance and symptoms in patients with mild to moderate Alzheimer's Disease (AD), and reduce burden associated with this debilitating illness.

Who is the study for?

This trial is for people aged 60 or older with mild to moderate Alzheimer's Disease, diagnosed by specialists. Participants must be stable on dementia medications if any, speak English or Spanish well enough for study procedures, and agree to an MRI scan. Those with unstable health conditions, skin issues where electrodes are placed, head trauma history, metal implants in the head/neck, or involved in other studies can't join.

What is being tested?

The study tests a tDCS device delivering either active or sham (fake) stimulation to the brain's dorsolateral prefrontal cortex at home. It aims to see if this treatment improves cognitive performance and symptoms over six months and affects neuroplasticity markers in patients with Alzheimer's.

What are the potential side effects?

tDCS may cause discomfort at the electrode site on the scalp, itching under the electrodes during stimulation sessions, headache after sessions end, fatigue or insomnia following treatments. Serious side effects are rare but could include seizures.

Eligibility Criteria

Inclusion Criteria

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

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I can speak and understand English or Spanish well enough for medical procedures.

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I have been diagnosed with Alzheimer's disease by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of head trauma, seizures, brain surgery, stroke, or cancer affecting my head.

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My medical and mental health conditions are stable.

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I have skin issues where electrodes might be placed.

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I have metal implants in my head or neck.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at 6 months (immediately after the 6-month intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at 6 months (immediately after the 6-month intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 6 months (immediately after the 6-month intervention) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Global Cognitive Performance

Secondary study objectives

Depressive Symptoms

Executive control/spatial selective attention

Functional Neuroplasticity - Flanker Interference Task

+5 more

Other study objectives

Durability of Global Cognitive Performance

Structural Neuroplasticity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

The active tDCS will involve 30-minutes of direct current at intensity of 2 milliamperes (mA).

Group II: Sham tDCSPlacebo Group1 Intervention

Sham stimulation consists of the direct current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining application period.

0 / 6Eligibility criteria met