Advance Study

ADvance StudyUsing Electrical Stimulation For Alzheimer’s Disease

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’s*, the ADvance II study is designed to establish the safety and efficacy of DBS of the fornix (DBS-f) for patients with mild Alzheimer’s. 

The ADvance II Study will initially involve about 210 people greater than or equal to 65 years of age that have been diagnosed with mild Alzheimer’s disease. The study is being conducted at sites in the U.S., Canada and Germany. 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 2/3 of the subjects, and off for 1/3. 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 48 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.

Study-related memory tests, physician exams and laboratory tests will be provided at no cost. Subjects will receive a stipend and reimbursed for travel expenses associated with each study visit. The ADvance II 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 II. 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 II Study.

Click here to learn more about ADvance II

 

 

* Lozano AM, Fosdick L, Chakravarty MM, et al. A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease. 2016;54:777-787. doi:10.3233/JAD-160017.

CAUTION — Investigational device. Limited by Federal law to investigational use.

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