The chair of Allegheny Health Network’s Neurosciences Institute discussed a groundbreaking phase 3 trial evaluating the safety and efficacy of deep brain stimulation in patients with Alzheimer disease. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"Now, we’re not only looking at safety, but the group is looking at efficacy to make sure its beneficial. It’s looking at patients with the stimulatory off and on to compare control group with active group, but also looking at it in a couple different frequencies. With deep brain stimulation, the electrode combination, pulse width, frequency, and amplitude all matter in the effect that you’re creating with stimulation."
For almost 2 decades, clinicians have used deep brain stimulation (DBS) to treat movement disorders such as Parkinson disease and essential tremor. This neurosurgical procedure uses implanted electrodes and electrical stimulation to essentially interrupt the irregular signals that drive symptoms. Now, a new phase 3 study dubbed ADvance II (NCT03622905), will explore the use of DBS to treat patients with Alzheimer disease (AD).
The international trial will include patients diagnosed with mild AD, aged at least 65 years, and will take place across 20 sites in the US, including Allegheny Health Network (AHN), as well as others in Canada and Germany. Following a standardized AD assessment, participants will be randomized 2:1 to DBS treatment with their neurostimulator either on or off. Notably, patients whose device is off at the start of the study will have it activated after 12 months.
ADvance II builds upon findings from the original ADvance study (NCT01608061), which found DBS targeting the fornix to be safe in patients with AD over a 2-year period. Donald Whiting, MD, chair, Neurosciences Institute, AHN, will be heading one of the trial sites at which ADvance II will be conducted. He sat down with NeurologyLive® to discuss the details of the new trial, what leftover questions remain from the first study, ADvance and how DBS will be specifically implanted in patients with AD. He also provided background on why there is optimism regarding this study, citing work previously done by Andres Lozano, MD, PhD, FRCPC, FRSC, FCAHS, using DBS in obesity.