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Device

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

N/A
Recruiting
Led By Joe Verghese, MBBS
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
Willing to complete an MRI
Able to speak and understand English or Spanish at a level sufficient to undergo the study procedures and testing protocols
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).
Awards & highlights

NICE-AD Trial 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.Check my eligibility
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.See study design
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.

NICE-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to undergo an MRI scan.
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I can speak and understand English or Spanish well enough for medical procedures.
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My dementia is in the mild to moderate stage.
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I have been diagnosed with Alzheimer's disease by a specialist.
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I am 60 years old or older and live in a community setting.

NICE-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 6 months (immediately after the 6-month intervention) and 9-months (3 months post-intervention).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 6 months (immediately after the 6-month intervention) and 9-months (3 months post-intervention). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Global Cognitive Performance
Secondary outcome measures
Depressive Symptoms
Executive control/spatial selective attention
Functional Neuroplasticity - Flanker Interference Task
+5 more
Other outcome measures
Durability of Global Cognitive Performance
Structural Neuroplasticity

NICE-AD 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.

Find a Location

Who is running the clinical trial?

MJHS Institute for Innovation in Palliative CareOTHER
5 Previous Clinical Trials
1,603 Total Patients Enrolled
Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,856,419 Total Patients Enrolled
Joe Verghese, MBBSPrincipal InvestigatorAlbert Einstein College of Medicine
3 Previous Clinical Trials
1,226 Total Patients Enrolled

Media Library

tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04404153 — N/A
Alzheimer's Disease Research Study Groups: Sham tDCS, Active tDCS
Alzheimer's Disease Clinical Trial 2023: tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS Highlights & Side Effects. Trial Name: NCT04404153 — N/A
tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404153 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment capacity for this medical experiment?

"Affirmative. Per the clinicaltrials.gov website, this clinical trial is still accepting participants since it was initially posted on March 25th 2021 and last updated July 29th 2022. 100 individuals are needed for the study at a single site."

Answered by AI

Is the recruitment process still ongoing for this clinical trial?

"Clinicaltrials.gov indicates that this investigation is actively seeking participants, with the initial posting on March 25th 2021 and a recent update appearing on July 29th 2022."

Answered by AI
~29 spots leftby Jul 2025