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Device

Deep Brain Stimulation for Alzheimer's Disease

N/A
Waitlist Available
Led By Dave Blake, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 - 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate using Deep Brain Stimulation to improve Alzheimer's symptoms and may even reverse the disease. It'll test safety and effectiveness, change in cognition, and biomarkers. Success could lead to a new treatment!

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from device implantation surgery, risks associated with general anesthesia, headache or dizziness post-surgery, possible infection at electrode sites and adverse reactions to MRI/PET scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 - 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 - 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Dementia Rating score change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
908 Previous Clinical Trials
934,585 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
746 Previous Clinical Trials
857,987 Total Patients Enrolled
Dave Blake, PhDPrincipal InvestigatorAugusta University
Dario Englot, MS, PhD, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Boston Scientific, VERCISE GENUS™ system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05882344 — N/A
Alzheimer's Disease Research Study Groups: Deep Brain Stimulation
Alzheimer's Disease Clinical Trial 2023: Boston Scientific, VERCISE GENUS™ system Highlights & Side Effects. Trial Name: NCT05882344 — N/A
Boston Scientific, VERCISE GENUS™ system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05882344 — N/A
~1 spots leftby Oct 2028
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