Status:
ACTIVE_NOT_RECRUITING
Neurostimulation for Cognitive Enhancement in Alzheimer's Disease
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
MJHS Institute for Innovation in Palliative Care
Stony Brook University
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 r...
Detailed Description
The hallmark of Alzheimer's Disease (AD) is cognitive decline with varied associated symptoms and signs. Unfortunately, there is no cure as yet for AD. Available treatments, including 5 FDA-approved m...
Eligibility Criteria
Inclusion
- Community-dwelling male or female of age 60 and older.
- AD diagnosed by neurologists or geriatricians at our dementia and geriatric clinical sites. Clinicians will review the medical records of all potential cases to ensure the patients meet established clinical criteria for AD, and also examine individuals as needed to further establish the diagnosis. Mild-to moderate stage AD as determined by study clinicians using the Clinical Dementia Rating Scale (CDR). The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. The necessary information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant (e.g., family member). A CDR score of 0.5 or 1 is rated as mild severity and a score of 2 is rated as moderate severity. The investigators selected mild to moderate AD patients as our target population as they are the most prevalent AD severity group referred to our clinics, increasing generalizability. This mild to moderate AD group is also most likely to be cared for in the community and at home, in contrast to more advanced or severe AD stages, which are more prevalent in institutional settings (and will be the focus of our future studies).
- If on dementia medication regimen, the regimen is stable for at least 4 weeks prior to enrollment. The investigators will not restrict clinicians from starting, adjusting or stopping dementia medications over the intervention period in keeping with the pragmatic nature of our trial, but will account for medications in both groups in our analysis.
- Able to speak and understand English or Spanish at a level sufficient undergo the study procedures and testing protocols.
- Willing to complete an MRI (exclusions relevant to neuroimaging are described below).
- Able to provide Informed Consent (or able to provide assent with a legal surrogate providing informed consent.)
Exclusion
- 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 (e.g., eczema, severe rashes, blisters, open wounds, burn including sunburns, cuts or irritation).
- Currently participating in another intervention study or using neurostimulation device.
- Exclusions specific to neuroimaging procedure: the presence of any surgically implanted metallic devices, such as aneurysm clips or pacemakers that would be a safety contraindication for MRI. Subjects with large amounts of dental or surgical hardware in the head and neck will be excluded because magnetic susceptibility effects will lead to severe image artifacts in these subjects' images. Due to the confined space of the MRI magnet, subjects with a known history of claustrophobia will also be excluded as will subjects with weight \>350lbs or waist circumference \>55 inches.
- Must not be currently receiving or have received (or completed) within the past 3 months any monoclonal antibody treatment for Alzheimer's
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04404153
Start Date
March 25 2021
End Date
January 1 2026
Last Update
November 4 2025
Active Locations (1)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461