Deep Brain Stimulation for Alzheimer's
Alzheimer Disease, Early Onset, Dementia, Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring Stimulation, Nucleus Basalis, Alzheimer, Memory
Eligibility Criteria
Inclusion Criteria: Probable, early-stage AD, as defined by NIA-AA 2018 criteria, including amnestic Mild Cognitive Impairment (MCI) Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a memory box score of at least 0.5 MMSE ³ 23 Stable cognitive enhancer medication equivalent to 10 mg/day donepezil or less for at least 60 days Stable other medications (e.g., psychotropics) Valid informed consent if female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study an available caregiver willing to participate subject is living at home and likely to remain at home for the study duration. Exclusion Criteria: Active or unstable psychiatric illness Inability to tolerate general anesthesia. Another concurrent CNS condition or clinical co-morbidity interfering with the study (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology). Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit Verbal IQ<85 Contraindication regarding anesthesia, stereotactic operation, MRI (e.g. claustrophobia, or implants), or PET (e.g. insulin dependent diabetes) procedures Inability to undergo PET or MRI imaging Active alcohol or substance abuse as defined by DSM5 Is unable or unwilling to comply with protocol follow-up requirements Is actively enrolled in another concurrent clinical trial. Terminal illness associated with expected survival of <12 months
Sites / Locations
- Vanderbilt Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Deep Brain Stimulation
Non-Deep Brain stimulation
Patients who are implanted and receive intermittent stimulation daily for the first 12 months
Patients who are implanted but do not receive intermittent stimulation daily for 12 months, but receive it after this period for the duration of the study