NICE-AD (Neurostimulation for Cognitive Enhancement in Alzheimer’s Disease)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • sponsor
    NIH
Updated on 2 November 2021
dementia

Summary

The NICE-AD study is a home-based clinical trial examining a treatment for Alzheimer’s Disease. We are interested in examining the effects of the device on cognition, mood, and neuroplasticity in patients with Alzheimer’s Disease. 

Description

For this study, we will ask you (or the person you care for) to use a neurosimulation device at home, 30 minutes/day, 5 days/week, for 6 months. The neurostimulation device is worn like a headband and emits a painless current to the frontal lobe of the brain. The device is FDA-approved and has a good safety profile.

We will also ask you to take part in several appointments at Einstein. Two will take place before the 6-month intervention begins, and three will take place after the 6-month intervention. In some of these visits we will ask you to undergo an MRI, and in all of them we will ask you questions about your mood, health, and memory.

We provide free car service to and from the study and compensate you (up to $460) for your time. If you have any questions about the study or are interested in learning more about it please reach out to us.

Details
Condition Alzheimer's Disease, Moderate Alzheimer's Disease, Home-Based Intervention, Alzheimer's, Mild Alzheimer's, Neurostimulation
Clinical Study IdentifierTX274264
SponsorNIH
Last Modified on2 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Community-dwelling male or female of age 60 and older
Mild-to moderate stage Alzheimer’s Disease
Able to speak and understand English at a level sufficient to undergo the study procedures and testing protocols
Willing to complete an MRI

Exclusion Criteria

Unstable medical or major psychiatric illnesses or unstable treatments for medical or major psychiatric illnesses. Any medical or psychiatric diagnosis is permitted as long as it has been clinically stable for at least 3 months, reflected in part by stability of treatments for at least 3 months, and is expected on the basis of clinical judgment to be in a stable phase that will likely extend for 6 months
History of head trauma, seizures, brain surgery, stroke or cancer affecting head, metal implants in the head or neck, compromised integrity or sensitivity of the skin at or near locations where electrodes will be placed
Currently participating in another intervention study or using neurostimulation device
Standard neuroimaging exclusions
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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