tDCS for Alzheimer's Disease
(NICE-AD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current dementia medications, but your medication regimen should be stable for at least 4 weeks before joining. Your doctor can still adjust your medications during the trial if needed.
What data supports the effectiveness of the treatment tDCS for Alzheimer's Disease?
Research shows that transcranial direct current stimulation (tDCS) has been effective in reducing symptoms of depression, with significant improvements noted in patients after several weeks of treatment. This suggests that tDCS may have potential benefits for other brain-related conditions, like Alzheimer's Disease, although direct evidence for Alzheimer's is not provided.12345
Is transcranial direct current stimulation (tDCS) generally safe for humans?
Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans when used in conventional protocols, with no reports of serious adverse effects in over 33,200 sessions. However, some studies caution that tDCS could potentially be harmful, so it's important to follow medical guidance and use approved devices.46789
How does tDCS treatment for Alzheimer's differ from other treatments?
tDCS (transcranial direct current stimulation) is a unique treatment for Alzheimer's because it is a noninvasive method that uses a small electrical current to stimulate the brain, potentially improving cognitive function. Unlike traditional drug treatments, tDCS can be administered at home and focuses on modulating brain activity rather than altering brain chemistry.24101112
What is the purpose of this trial?
The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.
Research Team
Joe Verghese, MD
Principal Investigator
Stony Brook University
Lara Dhingra, PhD
Principal Investigator
Metropolitan Jewish Health System
Mirnova Ceide, MD
Principal Investigator
Albert Einstein College of Medicine
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive remotely supervised active tDCS or sham tDCS stimulation over the dorsolateral prefrontal cortex for 30 minutes, 5 times per week for 6 months at home
Follow-up
Participants are monitored for durability of tDCS effects on cognitive performance and neuroplasticity
Treatment Details
Interventions
- tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS
- tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS
tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS is already approved in United States, European Union for the following indications:
- Investigational use for cognitive enhancement in Alzheimer's disease
- Investigational use for cognitive enhancement in Alzheimer's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albert Einstein College of Medicine
Lead Sponsor
Stony Brook University
Collaborator
MJHS Institute for Innovation in Palliative Care
Collaborator