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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 - 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 - 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Dementia Rating score change
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Deep Brain StimulationActive Control2 Interventions
Patients who are implanted and receive intermittent stimulation daily for the first 12 months
Group II: Non-Deep Brain stimulationPlacebo Group2 Interventions
Patients who are implanted but do not receive intermittent stimulation daily for 12 months, but receive it after this period for the duration of the study
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,184 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
933,390 Total Patients Enrolled
Dave Blake, PhDPrincipal InvestigatorAugusta University
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Eligibility Criteria:
This trial includes the following eligibility 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.I cannot undergo certain medical procedures due to health issues or implants.I cannot undergo surgery with general anesthesia.My other medications, like those for mental health, have not changed recently.I am post-menopausal, surgically sterile, or willing to use birth control during the study.I do not have any brain conditions like stroke or dementia that could affect the study.I do not have an active or unstable psychiatric condition.
Research Study Groups:
This trial has the following groups:- Group 1: Deep Brain Stimulation
- Group 2: Non-Deep Brain stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are minors within the age parameters of this research program?
"The requirements for this medical trial necessitate that patients must be between 60 and 80 years of age. Separate research is being done on individuals under 18, with 28 studies ongoing; there are 748 separate investigations devoted to those over 65 as well."
Answered by AI
What are the eligibility requirements for participating in this research project?
"To be eligible, those with Alzheimer's must fall between 60 and 80 years of age. A total of 8 candidates will be admitted into this medical trial."
Answered by AI
Is this experiment still recruiting participants?
"As indicated by the clinicaltrials.gov database, this particular medical trial has concluded its recruitment of patients as it was last edited on May 19th 2023. Although currently inactive, there are 756 other trials actively searching for volunteers at present time."
Answered by AI
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