Deep Brain Stimulation for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new procedure called intermittent Deep Brain Stimulation (DBS) to determine if it can help individuals with early-stage Alzheimer's disease maintain or improve their cognitive abilities over two years. Participants in the experimental group will receive daily DBS sessions, while the control group will continue with standard care without this treatment. This trial suits those diagnosed with early Alzheimer's who live at home, have a caregiver, and do not have other types of dementia or major mental health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative procedure.
Will I have to stop taking my current medications?
The trial requires that your current medications, like donepezil, be stable for at least 60 days before joining. This means you should not change your medication dose or start new medications during this time.
What prior data suggests that this procedure is safe for treating Alzheimer's disease?
Research shows that intermittent Deep Brain Stimulation (DBS) on the nucleus basalis of Meynert is generally safe. Studies have found no serious negative effects from this treatment. Patients in these studies experienced no major side effects and tolerated the procedure well. DBS has also improved thinking and memory. Although this trial is still in the early stages, safety results from other studies are encouraging for potential participants.12345
Why are researchers excited about this trial?
Unlike the standard treatments for Alzheimer's, which often involve medications like cholinesterase inhibitors and memantine, intermittent deep brain stimulation targets the brain directly. This technique focuses on the nucleus basalis of Meynert, which is crucial for memory and cognitive function. Researchers are excited because this method could potentially slow cognitive decline more effectively by directly influencing brain activity, offering hope for improved outcomes where traditional medications fall short.
What evidence suggests that intermittent Deep Brain Stimulation might be an effective treatment for Alzheimer's?
This trial will evaluate the effects of intermittent deep brain stimulation (DBS) of the nucleus basalis of Meynert on Alzheimer's disease. Research has shown that DBS in this brain area can improve thinking and memory in Alzheimer's patients. Studies have found that it can enhance memory and self-care skills without worsening the disease. Animal studies support these findings, indicating that stimulating this part of the brain can enhance thinking abilities and increase blood flow. Specifically, one study discovered that occasional stimulation improved working memory, which is crucial for everyday activities. Overall, DBS in this brain region appears promising for helping Alzheimer's patients maintain or even improve cognitive abilities.23678
Are You a Good Fit for This Trial?
This trial is for individuals aged 65-85 with early-stage Alzheimer's Disease, confirmed by specific criteria and a positive PET scan for beta amyloid. Participants must have mild cognitive impairment, an available caregiver, live at home, and be on stable Alzheimer's medication. Excluded are those with major psychiatric disorders, recent significant head trauma, other forms of dementia or brain lesions, terminal illness with less than 30 months expected survival, or any unstable medical condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert
Find a Clinic Near You
Who Is Running the Clinical Trial?
Augusta University
Lead Sponsor