On the CDR-SB, patients in the placebo group worsened by an average of 3.5 at one year. In comparison, the worsening was 2.1 in the DBSf treatment arm. The trend toward slowing of clinical decline was not statistically significant (p = 0.17).
Safety Results
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DBSf demonstrated an acceptable safety and tolerability profile in the ADvance study analysis, as previously reported. SAEs were consistent with what is typically observed in DBS of other study populations, including Parkinson's disease patients, the most common population treated with DBS.
About Alzheimer's Disease
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral disturbances that eventually result in a person's inability to perform daily activities. In 2010, it was estimated that 25 million individuals were living with AD worldwide.
About Deep Brain Stimulation
Deep brain stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. The therapy is currently licensed in the United States, Europe, Canada and other regions of the world for the treatment of the disabling symptoms of essential tremor and advanced Parkinson's disease. It is available under a Humanitarian Device Exemption (HDE)1 for primary dystonia in the United States. In Europe, Canada, Australia and Taiwan, DBS therapy is approved for the treatment of refractory epilepsy. The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union, Australia and in the United States under an HDE2. More than 100,000 people worldwide have received DBS therapy.
About Functional Neuromodulation, Ltd.
Functional Neuromodulation is a privately held medical device company dedicated to advancing the application of DBSf therapy to help improve the lives of people with Alzheimer's disease and other diseases of memory and cognition. Founded in 2010 in Toronto by Dr. Andres Lozano, Functional Neuromodulation has recently announced 12-month results of the ADvance study of DBSf in mild Alzheimer's disease patients. More information about the company can be found at www.fxneuromod.com.
1 Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated.
2 Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.
