NCT07218081 · Phase 1 · RECRUITING
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
This trial is testing whether surgically implanted electrodes that deliver brief pulses of electricity to a deep brain region called the nucleus basalis of Meynert can slow or stabilize memory loss in people with early Alzheimer's disease. Up to six people will receive the device; six others will serve as a comparison group on standard care. This is a Phase 1 trial, meaning the main focus is establishing basic safety and feasibility in a very small number of people — it is not yet proven to work.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-07