University of Nebraska Medical Center | Cardiovascular Department
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The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer's disease rating scale (iADRS).
Enrollment
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Inclusion criteria
Informed consent signed by the subject and caregiver.
At least 65 years old
Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
Mild dementia according to the Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening.
ADAS-cog-11 score of 10-24 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1).
Confirmation of Alzheimer's disease based on CSF biomarkers.
The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function and signs the informed consent for participation as such.
Patient must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team.
Fluency (oral and written) in the language in which standardized tests will be administered.
The patient is either
taking a stable dose of cholinesterase inhibitor (AChEI) medication (donepezil, galantamine, or rivastigmine) for at least 60 days prior to signing the informed consent form OR
the patient has previously had an intolerance/failure to cholinesterase inhibitor medications that can be documented AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified during the 12-month control period).
OR
c) a physician has fully discussed the possibility of prescribing cholinesterase inhibitors and the physician in collaboration with the patient/caregiver have declined trying cholinesterase inhibitors and this discussion and decision are fully documented in the patient's medical records. This discussion occurred during the course of the patient's care, and not as a component of enrollment or discussion of participation in this clinical trial.
AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified after study initiation for the 12-months control period).
Exclusion criteria
Primary purpose
Allocation
Interventional model
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74 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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