Phase 3 Clinical Trial for Alzheimer’s Treatment Seeks Volunteers
The ADvance II Study sponsored by Functional Neuromodulation is currently seeking volunteers to participate in a clinical trial for mild Alzheimer’s disease.
With a lack of effective long-term treatments, researchers are working hard to find new and better future treatments for patients with Alzheimer’s. Advances in treatment are possible through volunteers participating in clinical research studies like ADvance II. 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.
The ADvance II Study will involve about 210 people 65+ years of age that have been diagnosed with mild Alzheimer’s disease. The study is FDA approved for enrollment at 24 sites in the U.S., plus additional sites in Canada and Germany. The neurosurgeons participating in this study have extensive experience with performing DBS surgery. All subjects in the study will have a DBS-f system implanted; for 2 out of 3 subjects the device will be turned on immediately, for the remaining 1 out of 3, the device will be turned on at the 12-month visit.
The ADvance II Study for mild Alzheimer’s disease is now enrolling patients. Study-related memory tests, physician exams, and laboratory tests will be provided at no cost. The surgery and device costs are approved for coverage by Medicare. Subjects will receive a stipend and be reimbursed for travel expenses associated with each study visit.