Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07218081

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alzheimer Dementia (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wellstar MCG Hospital, Neurology Memory Clinic

Augusta, Georgia, 30912, United States

Location status: Recruiting

Location contact

John Morgan, MD, PhD

CONTACT

[email protected]

(706) 721-4581

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent deep brain stimulation of the nucleus basalis of Meynert

Device

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

Primary outcomes

  1. Dementia Rating Scales

    Time frame: Two years after intervention onset

    Subjects will be evaluated using the Clinical Dementia Rating Sum of Boxes scale. The investigators seeks for half of the intervention arm participants to have better (lower) or equal scale scores two years after intervention onset than they had at onset. This scale ranges from 0 to 18, and subjects will score from 2 to 6 at study entry.

  2. Alzheimer's Disease Assessment Scale, Cognitive Subscale

    Time frame: Two years of intervention

    The investigators seeks for scores on the Alzheimer's Disease Assessment Scale, Cognitive Subscale, to be equal or lower in half of the participants two years after the intervention begins compared to their value at study onset. This scale ranges from 0 to 85, and subjects at onset will likely have scores between 13 and 30.

Secondary outcomes

  1. PET scans for beta amyloid

    Time frame: Two years after study onset.

    PET scans will be obtained at onset and annually through two years. The investigators seek for a reduction in the Standard Uptake Volume Ratio (SUVr) in the intervention arm compared to the control arm. SUVr is a ratio of image intensity in a reference region of the brain compared to the cerebral cortex. SUVr averages 1.22 in subjects diagnosed with Alzheimer's, and 1.0 in non-Alzheimer's controls.

  2. Anxiety scales

    Time frame: Two years of intervention

    Subjects will receive a GAD-7 questionnaire at the same times as cognitive assessments. The investigators seek for reductions in the GAD-7 values in the intervention arm compared to the control arm. The GAD-7 scale ranges from 0 to 21, and higher scores indicate more anxiety.

  3. Beta amyloid PET imaging, Centiloid scale.

    Time frame: Two years of intervention

    PET scans will be obtained from particpants at onset and annually through two years. The investigators seek for a reduction in the Centiloid Scale in the intervention arm compared to the control arm. The Centiloid scale is 0CL on average in a 45 year old normal, and 100CL in a person with Alzheimer's dementia.

  4. PHQ-9 questionaire

    Time frame: Two years of intervention

    Participants will receive a PHQ-9 questionnaire at the same times as cognitive assessments. The investigators seek for reductions in this scale in the intervention arm compared to the control arm. The PHQ-9 depression scale has scores from 0 to 27, and higher scores indicate more depression.

Study contacts

Contact information is provided by the study sponsor or research team.

David T Blake, PhD

CONTACT

[email protected]

415-515-2659

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Cognitive Brain Aging Reversal From Deep Brain Stimulation for Alzheimer's Dementia: a Clinical Trial.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.