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

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Dementia (AD)

• Registration Number: NCT07218081
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-29
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-15
• Last Update Submitted: 2025-10-15
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Study Start: 2025-11-01
• Primary Completion: 2028-11
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dementia Rating Scales	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.
Alzheimer's Disease Assessment Scale, Cognitive Subscale	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 Outcome Measures

Name	Time	Method
PET scans for beta amyloid	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.
Anxiety scales	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.
Beta amyloid PET imaging, Centiloid scale.	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.
PHQ-9 questionaire	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.

Trial Locations

Locations (1)

Wellstar MCG Hospital, Neurology Memory Clinic; 🇺🇸 Augusta, Georgia, United States