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COMPLETED
NCT04404153
NA

Neurostimulation for Cognitive Enhancement in Alzheimer's Disease

Sponsor: Albert Einstein College of Medicine

View on ClinicalTrials.gov

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.

Official title: Non-Invasive Home Neurostimulation for Mild to Moderate Alzheimer's Disease: Double-Blind, Sham Controlled Randomized Clinical Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-03-25

Completion Date

2026-02-19

Last Updated

2026-09-22

Healthy Volunteers

No

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).

Locations (1)

Albert Einstein College of Medicine

The Bronx, New York, United States