Have a reliable informant (spouse, relative, caregiver) who can attend all study visits and report on your daily activities and function
Are in good general health
Are on 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 OR 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.
About the Study:
The ADvance II Study is researching the use of a surgically implanted device that delivers mild electrical pulses to specific areas of the brain in people with Alzheimer’s. This deep brain stimulation (known as DBS) will be given to the fornix, a place in the brain that plays a central role in memory. Based on results of a study of 42 patients with Alzheimer’ the ADvance II study is designed to evaluate the safety and efficacy of DBS of the fornix (DBS-f) for patients with mild Alzheimer’s disease.
The purpose of this study is to see what benefits and associated risks of deep brain stimulation of the fornix (DBS-f) exist in patients with mild Alzheimer’s disease. This study will look at the effects in patients with mild Alzheimer’s disease who are already taking one of the medications mentioned in the eligibility requirements for the treatment of Alzheimer’s. The system (the wires and battery that generates the electricity) to deliver the deep brain stimulation is already approved for use in the treatment of movement disorders such as Parkinson’s disease so it is not experimental for that purpose.
What is Involved:
If you meet all of the inclusion and none of the exclusion criteria for the study, you will be offered a second informed consent form for your review and consent before taking part in the research study. After your baseline visit and implantation (placement) of the device, scheduled follow-up visits will occur at 2 weeks post-implant and at months 3, 6, 12, 15, 18, 24, 36 and 48. After 48 months, you will exit the study.