Recruiting
Phase 1

Deep Brain Stimulation

Sponsor:

Augusta University

Code:

NCT07218081

Conditions

Alzheimer Dementia (AD)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Intermittent deep brain stimulation of the nucleus basalis of Meynert

Study Details

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 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

Alzheimer Dementia (AD)

Study ID

NCT07218081

Start date

Feb 1, 2026

Status verified date

Jan, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • • 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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intermittent deep brain stimulation of the nucleus basalis of Meynert

Subjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day. Assessments will be performed at onset, after four weeks of intervention, and each six months through two years.

no intervention: Control group

Subjects will have matching eligility criteria as those in the experimental arm, but will receive no intervention. Assessments will be performed at study onset, and each six months through two years after onset.

Interventions

Intermittent deep brain stimulation of the nucleus basalis of Meynert

Subjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day.

Primary outcome measure

  • Dementia Rating Scales [ Time Frame: Two years after intervention onset ]
  • Alzheimer's Disease Assessment Scale, Cognitive Subscale [ Time Frame: Two years of intervention ]

Central Contacts and Locations

Central contacts

David T Blake, PhD

415-515-2659dblake@augusta.edu

Locations

Wellstar MCG Hospital, Neurology Memory Clinic

Recruiting

Augusta, Georgia, United States, 30912

Contacts

John Morgan, MD, PhD

(706) 721-4581jmorgan@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • deep brain stimulation
  • alzheimer's
  • nucleus basalis of Meynert

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2026-01-07.