Neurostimulation for Cognitive Enhancement in Alzheimer's Disease

Summary

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.

Conditions

• Alzheimer Disease
• Dementia

Interventions

DEVICE

tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.

At-home remotely supervised tDCS delivered over the dorsolateral prefrontal cortex with the anode on the left, cathode on the right, at an intensity of 2 mA, delivered for 30 minutes five times per week (Monday-Friday) for 26 weeks (6 months).

DEVICE

tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.

Sham treatment will consist of the current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining time of the 30-minute application period five times per week (Monday-Friday) for 26 weeks (6 months).

Sponsors & Collaborators

• MJHS Institute for Innovation in Palliative Care

  collaborator OTHER

• Stony Brook University

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• Albert Einstein College of Medicine

  lead OTHER

Principal Investigators

• Joe Verghese, MD · Stony Brook University

• Lara Dhingra, PhD · Metropolitan Jewish Health System

• Mirnova Ceide, MD · Albert Einstein College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-25

Primary Completion

2025-10-28

Completion

2026-02-19

FDA Device

Yes

Countries

• United States

Study Locations