Intermittent Stimulation of the Nucleus Basalis of Meynert Improves Working Memory in Adult Monkeys.
Ruifeng Liu, Jonathan Crawford, Patrick M Callahan...
https://pubmed.ncbi.nlm.nih.gov/28823679/Actively Recruiting
Led by Augusta University · Updated on 2026-01-07
12
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating a new procedure called intermittent Deep Brain Stimulation DBS of the nucleus basalis of Meynert to treat Alzheimers disease. This study aims to see if DBS can sustain or improve cognitive abilities in people with early-stage Alzheimers over at least two years. The trial will include a total of up to twelve participants, with half receiving DBS and the other half receiving standard care without DBS for comparison. Participants in the DBS group will receive stimulation for 50 minutes daily. Both groups will undergo assessments at the start, after four weeks DBS group only, and then every six months for two years. The control group will have matching eligibility but will not receive the DBS intervention. This non-randomized, open-label trial will be conducted by Augusta University. Throughout the study, participants will have evaluations using dementia rating scales and cognitive assessments at two years. Additional measures include PET scans for beta amyloid, anxiety scales, and questionnaires related to depression and neuropsychiatric symptoms. Participants must live at home with caregiver support and will be monitored regularly to assess cognition and overall safety during the study period, which lasts up to two years.
CONDITIONS
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
D
David T Blake, PhD
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Augusta University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | DBS of Nucleus Basalis of Meynert | No Investigational Intervention |
|---|---|---|
| What is it? | An investigational therapy using implanted electrodes to deliver intermittent electrical stimulation to the nucleus basalis of Meynert for 50 minutes per day. | Eligible participants who do not undergo surgery or receive any investigational device, observed under current clinical care for Alzheimer's dementia. |
| Role in trial | Experimental intervention group. | Control group that does not receive the device or active intervention. |
| Primary use/purpose | To assess whether intermittent DBS of the nucleus basalis of Meynert improves cognitive function and slows progression in early Alzheimer's dementia. | Provides a baseline for comparison and tracks usual progression in similar patients without intervention. |
| How is it given or performed? | Surgically implanted electrodes deliver daily electrical stimulation to the targeted brain region for 50 minutes. | Participants receive standard care without undergoing surgical procedures or device implantation. |
| Evidence status | Supported by preclinical studies showing improved cognition in animal models, but human effectiveness in Alzheimer's dementia remains under clinical investigation. | Standard observational management in early Alzheimer's dementia, with only symptom-targeted supportive care and no available disease-modifying therapy. |
| Important limitations | Evidence is preliminary, limited to animal studies and early-phase clinical trial settings. Data on long-term effects and safety in Alzheimer's dementia are not yet established. | No disease-modifying therapies exist for Alzheimer's dementia; symptom progression in the observational group reflects the natural course of the disease. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Two years
Participants receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day or no intervention if in the control group.
Assessments at onset, after four weeks, and every six months through two years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Ruifeng Liu, Jonathan Crawford, Patrick M Callahan...
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https://pubmed.ncbi.nlm.nih.gov/39924100/Augusta University
Lead Sponsor