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advanceUsing Electrical Stimulation For Alzheimer’s Disease

The ADvance 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 small study of 6 patients with Alzheimer’s*, the ADvance study is designed to determine if DBS of the fornix (DBS-f) is safe and has potential clinical benefit for patients with mild Alzheimer’s.

The ADvance Study will initially involve about 20 people between the ages of 55 and 80 that have been diagnosed with mild Alzheimer’s disease. The study is being conducted at sites in the U.S. and Canada. The neurosurgeons participating in this study have extensive experience with DBS surgery. All subjects in the study will have a DBS-f system implanted, with the stimulation device turned on for half of the subjects, and off for half. For those with the device left off at the start of the study, they will have it turned on after 12 months. All study participants will be regularly assessed for at least 18 months to measure their rate of Alzheimer’s progression. The DBS-f system or certain components of the system are likely to remain in the body of study participants for the rest of their lives.

All equipment and surgical procedures related to the ADvance Study will be provided without any cost to study subjects. Study-related memory tests, physician exams and laboratory tests will be provided at no cost. Subjects will be reimbursed for travel expenses associated with each study visit. The ADvance study is sponsored by Functional Neuromodulation.

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. At this time, it is unknown whether patients will benefit from participating in this study. As with all clinical research, there are potential benefits and risks associated with participating. Study physicians will review all these with patients and their caregivers before being enrolled in the ADvance Study.

Caution:  Investigational Device. Limited by Federal law to investigational use.

* Laxton AW, Tang-Wai DF, McAndrews MP,  Zumstag D, et al. “Phase I Trial of Deep Brain Stimulation of Memory Circuits in Alzheimer’s Disease. ”  Ann Neurol, no. 68 (2010): 521-534.