Actively Recruiting
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
Led by Augusta University · Updated on 2026-01-07
12
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to test a new procedure to treat Alzheimer's disease. The procedure is called intermittent Deep Brain Stimulation (DBS) of the nucleus basalis of Meynert. There will be up to six participants enrolled at Wellstar MCG Memory Clinic. There will be another six participants similarly enrolled to act as a control group that does not receive DBS. This second group will document the course of progression of Alzheimer's disease under the normal standard of care. The main goal of the study is to determine if DBS can sustain or improve cognition in Alzheimer's disease for at least two years. Participant data, with identifying information removed, may be shared with online repositories for comparison with trials with similar subjects.
CONDITIONS
Official Title
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 85 years
- Probable early-stage Alzheimer's disease confirmed by NIA-AA 2018 criteria and positive PET for beta amyloid
- No Lewy body dementia or other dementia types
- Clinical Dementia Rating global score of 0.5-1.0 with CBR-sb score from 2 to 6
- Mini-Mental State Examination score of 21 or higher
- Stable psychopharmacological medication equivalent to 10 mg/day donepezil or less for at least 60 days
- Valid informed consent provided
- An available caregiver willing to participate
- Living at home and likely to remain there for the study duration
- Geriatric Depression Scale score of 5 or less
- Negative answers on Columbia Suicide Severity Rating Scale questions 3 through 5
- Neuropsychiatric Inventory under 2 on 'Delusions', 'Hallucinations', or 'Agitation/Aggression' subscales
You will not qualify if you...
- Clinical conditions interfering with the study such as recent head trauma, brain tumor, subdural hematoma, or other significant brain lesions on imaging
- Presence of implants that prevent high field MRI scans
- Current major psychiatric disorders including schizophrenia, bipolar disorder, or major depressive disorder, or history of suicidal attempts or crises
- Other central nervous system conditions like stroke, Parkinson's disease, Lewy body dementia, or significant brain structural pathology
- History of seizure disorder including epilepsy
- Terminal illness with expected survival less than 30 months
- Other dementia types including Lewy body disease, frontotemporal lobar degeneration, vascular disease, traumatic brain injury, HIV infection, prion disease, Parkinson's disease, Huntington's disease, or multiple causes
- Unstable medical or neurological conditions as judged by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wellstar MCG Hospital, Neurology Memory Clinic
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
D
David T Blake, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here