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

Korábbi kezelés

• • 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

• 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