Arm of AD Study Cancelled. Elan Corporation and Wyeth will discontinue the highest of three dosing regimens (2.0mg/kg) in the two ongoing Phase III studies of bapineuzumab in patients with mild to moderate Alzheimer's disease who do not carry the ApoE4 allele. The decision was made after its review of vasogenic edema (VE) in the Phase III trial. During a Phase II trial, VE was observed more frequently in patients who were carriers of the ApoE4 allele and was more likely to occur at higher doses of bapineuzumab. The companies will continue testing in two other ongoing studies, which are testing a single 0.5mg/kg dose in patients with ApoE4 allele. The study's Safety Monitoring Committee also had no concerns over the 1.0mg/kg dose.
Bucking Migraines. In efforts to raise $1 million for headache research, the National Headache Foundation has kicked off the Migraine Million campaign. The organization says 82 cents from every dollar it receives goes directly to research, programs, and services. Donations can be made online at headaches.org.
Diet Pills. If adding an AED onto the ketogenic diet for a pediatric patient, consider zonisamide. A retrospective study of 217 consecutive children who started the diet from 2000 to 2007 found that a greater than 50 percent reduction in seizures was significantly less likely for patients taking phenobarbital but was significantly more likely for those taking zonisamide. (Epilepsia, early view, April 20, 2009)
Spine Study Commences. A novel protein-based therapy for low back pain is now under investigation, according to DePuy Spine, Inc. (a Johnson & Johnson company), which is developing the treatment in collaboration with Advanced Technologies and Regenerative Medicine, LLC. The genetically engineered human protein, intradiscal rhGDF-5, injected into the lower spine may relieve pain and could slow or even reverse early stage degenerative disc disease, the company says.
Another J&J company and member of the DePuy family, Codman Neurovascular (formerly Cordis) has been established and may become familiar to neurologists. The company markets neurovascular coils, catheters, liquid embolics, and vascular reconstruction devices for minimally invasive treatment of aneurysms and cerebral arteriovenous malformations.
DBS in Children. Globus pallidus internus-deep brain stimulation offers an effective and safe therapy in children suffering from primary dystonia, according to a study presented during the 77th Annual Meeting of the American Association of Neurological Surgeons. In this study, results and long-term follow up data (36 to 85 month range) were analyzed in a group of five patients, age 16 or younger, suffering from primary generalized dystonia. All patients had cases of dystonia that were resistant to conservative approaches.
The entire patient group experienced significant improvement in symptoms as early as the first week, which further improved in the months to follow: The mean improvement in the Burke-Fahn-Marsden movement score was 67.4 percent (range 47 percent to 87.5 percent), 75.4 percent (range 61.5 percent to 91.7 percent), and 83.5 percent (range 72 percent to 93.3 percent) at three months, 12 months, and long-term follow-up, respectively.
Two patients experienced problems with the implanted devices: electrode dislocation and breakage of extension cable in one, and imminent perforation of extension cable in another. There was very mild dysarthric speech disturbance in two patients with no other therapy-related morbidity noted.
Stimulating Depression Treatment. Researchers have investigated cortical stimulation in patients with medically refractive major depression. The results of a study, Long Term Follow-up of Cortical Stimulation to Treat Major Depressive Disorder, were presented May 5 at Harvard Medical School. For the study, 12 patients were randomized to single blind active or sham stimulation for eight weeks; all subjects then received active stimulation. One patient was excluded from analysis due to a protocol deviation. Outcome assessments included the Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Depression Rating Scale (HDRS), and the Global Assessment of Functioning (GAF).
Improvements were seen: At 8 weeks, HDRS decreased by 22 percent (active: n=6) versus 3 percent (sham: n=5). MADRS decreased 22 percent (active) versus 8 percent (sham). GAF increased 23 percent (active) versus 12 percent (sham). In all patients, continued improvement was seen at 6 months (average HDRS: 20 percent) and 12 months (average HDRS: 33 percent).
At 12 months, patients whose electrodes were implanted >20 mm from the precentral sulcus averaged a 59 percent improvement in HDRS compared to a 12 percent improvement in patients (n=6) with electrodes <20mm from the precentral sulcus.
Epilepsy Surgery in Babies. Surgery is relatively safe for babies and toddlers with epilepsy and effective in controlling seizures, according to a study in Epilepsia (e-pub Jan. 2009). Further, the study says surgery may aid the brain development of the child. Researchers reviewed epilepsy surgeries in children three years old and younger between 1987 and 2005. Across Canadian pediatric neurosurgical centers 82 percent of 116 children started suffering from seizures this first year of life. And the surgeries themselves were notable. Children typically underwent major brain operations, including doctors removing or disconnecting half of the brain. Despite the seriousness of the surgery there few complications and only one death. Prior to surgery, the children experienced an average of 21 seizures per day. About 67 percent were seizure free and 14 percent had a better than 90 percent improvement one year after surgery. Only 7.5 percent saw no benefit from surgery.