A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.

Last updated: January 5, 2026
Sponsor: Augusta University
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Intermittent deep brain stimulation of the nucleus basalis of Meynert

Clinical Study ID

NCT07218081
2300118-2
  • Ages 65-85
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age:65 minimum

  • Age:85 maximum

  • Probable, early-stage Alzheimer's Disease, as defined by NIA-AA 2018 criteriaand 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 orless 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

Exclusion Criteria:

  • • clinical co-morbidity interfering with study (e.g. head trauma requiring medicaltreatment in the 2 years prior, brain tumor, subdural hematoma, or other clinicallysignificant space-occupying lesion on brain CT or MRI), or other implant precludinghigh field MRI scans.

  • current major psychiatric disorder such as schizophrenia, bipolar disorder ormajor depressive disorder based on psychiatric consult at screening visit, orpast medical history prior suicidal attempts or suicidal crises

  • Another concurrent CNS condition (ie, stroke, Parkinson's disease, Lewy-Bodydementia or other form of dementia, other evidence of significant structuralbrain 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 ofNeurocognitive 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 ofthe Principle Investigator

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Intermittent deep brain stimulation of the nucleus basalis of Meynert
Phase: 1
Study Start date:
February 01, 2026
Estimated Completion Date:
November 30, 2028

Connect with a study center

  • Wellstar MCG Hospital, Neurology Memory Clinic

    Augusta 4180531, Georgia 4197000 30912
    United States

    Active - Recruiting

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