Actively Recruiting

Phase 1
Age: 65Years - 85Years
All Genders
ID07218081

Cognitive Brain Aging Reversal Using Intermittent Deep Brain Stimulation of the Nucleus Basalis of Meynert for Alzheimer's Dementia

Led by Augusta University · Updated on 2026-01-07

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new procedure called intermittent Deep Brain Stimulation (DBS) of the nucleus basalis of Meynert to treat Alzheimer's disease. This study aims to see if DBS can sustain or improve cognitive abilities in people with early-stage Alzheimer's over at least two years. The trial will include a total of up to twelve participants, with half receiving DBS and the other half receiving standard care without DBS for comparison. Participants in the DBS group will receive stimulation for 50 minutes daily. Both groups will undergo assessments at the start, after four weeks (DBS group only), and then every six months for two years. The control group will have matching eligibility but will not receive the DBS intervention. This non-randomized, open-label trial will be conducted by Augusta University. Throughout the study, participants will have evaluations using dementia rating scales and cognitive assessments at two years. Additional measures include PET scans for beta amyloid, anxiety scales, and questionnaires related to depression and neuropsychiatric symptoms. Participants must live at home with caregiver support and will be monitored regularly to assess cognition and overall safety during the study period, which lasts up to two years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 65 and 85 years
  • Probable early-stage Alzheimer's disease confirmed by PET scan for beta amyloid
  • No Lewy-Body dementia or other dementia types
  • Clinical Dementia Rating global score between 0.5 and 1.0 with a CDR-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 study duration
  • Geriatric Depression Scale score of 5 or less
  • Columbia Suicide Severity Rating Scale with no positive answers on questions 3 to 5
  • Neuropsychiatric Inventory under 2 on delusions, hallucinations, or agitation/aggression subscales
Not Eligible

You will not qualify if you...

  • Clinical conditions interfering with study such as recent head trauma, brain tumor, subdural hematoma, or other significant brain lesions
  • Presence of implants that prevent high field MRI scans
  • Current major psychiatric disorders including schizophrenia, bipolar disorder, or major depressive disorder
  • Past suicidal attempts or crises
  • Other central nervous system conditions like stroke, Parkinson's disease, Lewy-Body dementia, or significant brain pathology
  • History of seizure disorders including epilepsy
  • Terminal illness with expected survival less than 30 months
  • Other dementia types under DSM-5 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 determined by the principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Two years

Participants receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day or no intervention if in the control group.

Assessments at onset, after four weeks, and every six months through two years

Trial Site Locations

Total: 1 location

1

Wellstar MCG Hospital, Neurology Memory Clinic

Augusta, Georgia, United States, 30912

Actively Recruiting

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Research Team

D

David T Blake, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Chronic basal forebrain activation improves spatial memory, boosts neurotrophin receptor expression, and lowers BACE1 and Aβ42 levels in the cerebral cortex in mice.

Jacob Kumro, Ashutosh Tripathi, Yun Lei...

https://pubmed.ncbi.nlm.nih.gov/36939283