Status:
RECRUITING
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
Lead Sponsor:
Augusta University
Conditions:
Alzheimer Dementia (AD)
Eligibility:
All Genders
65-85 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Age:65 minimum
- Age:85 maximum
- Probable, early-stage Alzheimer's Disease, as defined by NIA-AA 2018 criteria and positive PET for beta amyloid,
- no Lewy-Body-dementia or other form of dementia
- Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a CBR-sb score from 2 to 6.
- MMSE ≥ 21
- stable psychopharmacological medication equivalent to 10 mg/day donepezil or less for at least 60 days
- valid informed consent
- an available caregiver willing to participate
- subject is living at home and likely to remain at home for the study duration
- Geriatric Depression Scale of 5 or less
- Columbia Suicide Severity Rating Scale "No" on questions 3 through 5
- Neuropsychiatric Inventory (NPI-Q) under 2 on 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales
Exclusion
- • clinical co-morbidity interfering with study (e.g. head trauma requiring medical treatment in the 2 years prior, brain tumor, subdural hematoma, or other clinically significant space-occupying lesion on brain CT or MRI), or other implant precluding high field MRI scans.
- current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit, or past medical history prior suicidal attempts or suicidal crises
- Another concurrent CNS condition (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology).
- Medical history of seizure disorder including epilepsy
- Terminal illness associated with expected survival of \<30 months
- Subjects with one of these other forms of dementia in the DSM-5 heading of Neurocognitive Disorders: Lewy body disease, Frontotemporal lobar degeneration, Vascular disease, Traumatic brain injury, HIV infection, Prion disease, Parkinson's disease, Huntington's disease, or due to multiple etiologies
- Subjects with unstable medical and neurological conditions at the discretion of the Principle Investigator
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07218081
Start Date
February 1 2026
End Date
November 1 2028
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wellstar MCG Hospital, Neurology Memory Clinic
Augusta, Georgia, United States, 30912