Cholinergic Deep Brain Stimulation for Alzheimer's Disease

Summary

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.

Conditions

• Alzheimer Disease, Early Onset
• Dementia
• Alzheimer Disease

Interventions

PROCEDURE

Device Implantation- Boston Scientific, VERCISE GENUS™ system

Participants will be implanted with DBS leads bilaterally, targeting the Nucleus Basalis of Meynert. The study team will record Local Field Potentials with and without stimulation, intraoperatively. These results will help the team determine at the end of the study whether LFP desynchronization (decrease in 5-15 Hz power), or other physiological signature, can be used to predict the location that provides the most effective intervention. Finally, the team will also ascertain the safety of the procedure and NB stimulation itself.

DEVICE

DBS Stimulation - Boston Scientific, VERCISE GENUS™ system

Daily intermittent stimulation (60 Hz x 20s/min)

Sponsors & Collaborators

• Boston Scientific Corporation

  collaborator INDUSTRY

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Dave Blake, PhD · Augusta University

• Dario Englot, MS, PhD, MD · Vanderbilt University Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2028-10-31

Completion

2028-10-31

FDA Device

Yes

Countries

• United States

Study Locations