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

Augusta University

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer Dementia (AD)

Treatments: Device: Intermittent deep brain stimulation of the nucleus basalis of Meynert

Study type: Interventional

Funder types: Other

Identifiers

NCT07218081

2300118-2

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Intermittent deep brain stimulation of the nucleus basalis of Meynert

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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.