Trial Summary
What is the purpose of this trial?This project will investigate the potential of Deep Brain Stimulation to improve cognitive abilities and counteract the effects of Alzheimer's disease. Deep Brain Stimulation electrodes targeting the Nucleus Basalis of Meynert (NB) will be implanted bilaterally in a cohort of patients. NB is the sole source of acetylcholine to the neocortex. Such stimulation may not only treat the cognitive symptoms but may have disease-modifying effects. Drawing from animal experiments in non-human primates that showed success of this approach, intermittent stimulation will be delivered at 60 pulses per second for 20 seconds of each minute for one hour per day. The study team will recruit patients, shortly after first being diagnosed with Alzheimer's disease. The study design will test the safety and efficacy of stimulation, potential benefits in cognitive function assessed with a battery of neurocognitive tests, cholinergic neurotransmission evaluated with Positron Emission Tomography, and ability to reverse Alzheimer's biomarkers, including beta amyloid and tau in the cerebrospinal fluid. Successful completion of this project will lead to a potential new intervention for the cognitive impairments of Alzheimer's disease.
Eligibility Criteria
This trial is for early-stage Alzheimer's patients with mild cognitive impairment or dementia, scoring 23 or higher on the MMSE. Participants need a caregiver, must be living at home, and have stable medication use. They can't join if they have severe psychiatric illnesses, other brain conditions like Parkinson's disease, substance abuse issues, are unable to undergo PET/MRI scans or tolerate anesthesia.Inclusion Criteria
I have been diagnosed with early-stage Alzheimer's or memory loss.
I've been on a stable dose of medication for memory problems, equivalent to or less than 10 mg/day of donepezil, for at least 60 days.
Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a memory box score of at least 0.5
+5 more
Exclusion Criteria
Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
I cannot undergo certain medical procedures due to health issues or implants.
I cannot undergo surgery with general anesthesia.
+8 more
Participant Groups
The study tests Deep Brain Stimulation (DBS) using the VERCISE GENUS™ system targeting the Nucleus Basalis of Meynert in Alzheimer's patients. It aims to improve cognition and potentially modify the disease by delivering intermittent stimulation daily and measuring cognitive function changes along with Alzheimer’s biomarkers.
1Treatment groups
Active Control
Group I: Deep Brain StimulationActive Control2 Interventions
Patients who are implanted and receive intermittent stimulation daily for the first 12 months
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
Boston Scientific CorporationIndustry Sponsor