Phase
Condition
N/ATreatment
Intermittent deep brain stimulation of the nucleus basalis of Meynert
Clinical Study ID
Ages 65-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age:65 minimum
Age:85 maximum
Probable, early-stage Alzheimer's Disease, as defined by NIA-AA 2018 criteriaand 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 orless 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
Exclusion Criteria:
• clinical co-morbidity interfering with study (e.g. head trauma requiring medicaltreatment in the 2 years prior, brain tumor, subdural hematoma, or other clinicallysignificant space-occupying lesion on brain CT or MRI), or other implant precludinghigh field MRI scans.
current major psychiatric disorder such as schizophrenia, bipolar disorder ormajor depressive disorder based on psychiatric consult at screening visit, orpast medical history prior suicidal attempts or suicidal crises
Another concurrent CNS condition (ie, stroke, Parkinson's disease, Lewy-Bodydementia or other form of dementia, other evidence of significant structuralbrain 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 ofNeurocognitive 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 ofthe Principle Investigator
Study Design
Connect with a study center
Wellstar MCG Hospital, Neurology Memory Clinic
Augusta 4180531, Georgia 4197000 30912
United StatesActive - Recruiting

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