On 12 June 2013, Functional Neuromodulation announced that the ADvance study has implanted 20 mild Alzheimer’s patients with deep brain stimulation systems, and the US Food and Drug Administration (FDA) has approved expansion of the study from 20 to 30 US patients in combination with 20 subjects approved in Canada.
The US National Institutes of Health (NIH), according to a press release, has provided support for the trial. The National Institute on Aging (part of NIH), awarded a grant to Constantine Lyketsos, of Johns Hopkins Bayview Medical Center, Baltimore, USA, and Andres Lozano, of the University of Toronto, Toronto, Canada. The NIA/NIH grant is expected to total more than US$2 million over the next five years.
In addition, according to the release, Banner Sun Health Research Institute in Sun City, USA, and Brown University affiliated Butler and Rhode Island Hospitals in Providence, USA, have partnered and joined the study, bringing the total to seven centres participating in the study.
“We are halfway to our goal of enroling 40 patients in the USA and Canada. The study investigators have been very diligent in enroling appropriate patients with early Alzheimer’s disease,” said Todd Langevin, president and COO of Functional Neuromodulation. “We expect our progress to accelerate as we now have active teams of Alzheimer’s and neurosurgical experts in place and recruiting at seven leading research centres in North America.”
“Alzheimer’s is a growing public health concern, and with the recent disappointments in drug research, we urgently need new ideas,” said Stephen Salloway, a principal investigator for the study and director of the Memory and Aging Program at Butler Hospital. “Deep brain stimulation has helped transform the treatment of Parkinson’s disease and we hope that stimulation of memory circuits can have a similar benefit in treating Alzheimer’s disease.”
ADvance is a randomised double-blind controlled trial of patients under age 81 with mild Alzheimer’s disease. The trial compares the effects of deep brain stimulation turned on to those observed with the system turned off. The patients are expected to undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group will have the system activated. Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory will also be assessed at multiple time points, according to the release.