BOSTON, Nov. 6, 2015 /PRNewswire/ -- Functional Neuromodulation Ltd. announced that an analysis of the ADvance Study, a Phase 2 double-blind randomized controlled trial of DBSf for mild Alzheimer's disease (clinicaltrials.gov NCT01608061) is being presented today at the 2015 Clinical Trials in Alzheimer's Disease (CTAD) meeting in Barcelona, Spain.

"The company is taking a unique approach to Alzheimer's disease by treating it as a disorder of the memory circuit that has become less active due to neuronal deterioration. By applying electrical impulses to the circuit, ADvance results suggest that DBSf may keep the memory circuit active," said Anton P. Porsteinsson, MD, William B. and Sheila Konar Professor of Psychiatry at the University of Rochester and a member of the independent data safety monitoring board for the ADvance study. Dr. Porsteinsson stated further, "The results are encouraging. The study demonstrated an acceptable safety and a suggestion of clinical benefit in a subgroup of patients, which is supported by improvement in a biological marker. This approach clearly merits further clinical investigation."

Treatment with DBSf suggested clinical benefit at 12 months in patients aged 65 and older based on Clinical Dementia Rating sum of boxes (CDR-SB) and the Alzheimer's Disease Assessment Scale cognitive subscale - 13 item, (ADAS-Cog 13). In patients treated with DBSf, glucose metabolism, a biomarker for neuronal degeneration and disease progression, increased by 22% on average at 12 months while the placebo group declined by 1.2% on average. The surgery and brain stimulation demonstrated acceptable safety and was well tolerated.
"DBSf has demonstrated a statistically significant increase in brain glucose metabolism and a signal that memory circuit activation may slow progressive cognitive changes in AD," said Vince Owens, CEO of Functional Neuromodulation. "Based on these results, we are advancing the DBSf clinical program to Phase 3 with plans to initiate enrollment in mid-2016."

ADvance Trial

ADvance is a randomized, double blind, controlled trial of 42 patients age 45 to 85 with mild Alzheimer's disease to evaluate the potential clinical benefit and safety of DBS of the fornix, a major inflow and output pathway in the brain's memory circuit. All patients were implanted with DBS systems and randomized to receive stimulation or sham stimulation for 12 months. The study was supported through a grant from the National Institute on Aging, part of the National Institutes of Health, awarded to Andres Lozano, MD, PhD, R.R. Tasker Chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto and Constantine Lyketsos, MD, MHS, Elizabeth Plank Althouse Professor, Johns Hopkins University, and Director, Johns Hopkins Memory and Alzheimer's Treatment Center.

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