Neurimmune Begins Phase 3 Program for Aducanumab for Early Alzheimer's Disease
Neurimmune announced that the first patient has been enrolled in the global Phase 3 program for the investigational treatment aducanumab. The Phase 3 program includes placebo-controlled studies, Engage and Emerge.
Engage and Emerge will assess the efficacy and safety of aducanumab in approximately 2,700 individuals with early Alzheimer's disease. The studies are identical in design and eligibility criteria. Each study will be conducted in more than 20 countries in North America, Europe, and Asia.
Aducanumab is thought to target aggregated forms of beta amyloid, including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of patients with Alzheimer's disease. Interim Phase Ib clinical data demonstrated that aducanumab reduced amyloid from the brains of patients with early stages of Alzheimer's disease in a dose- and time-dependent manner.
Source.“Neurimmune Receives Major Development Milestone Upon Initiation of Global Phase 3 Studies With Aducanumab for Early Alzheimer's Disease.” (2015, September 8). Retrieved October 29, 2015, from http://prn.to/20dxvhq.
Resveratrol Stabilizes Alzheimer's Disease Biomarker
The largest nationwide clinical trial to study high-dose resveratrol long-term in individuals with mild to moderate Alzheimer's disease found that a biomarker that declines when the disease progresses was stabilized in those who took the purified form of resveratrol. The trial was a randomized, Phase 2, placebo-controlled, double-blind study of 119 patients with mild to moderate dementia due to Alzheimer's disease.
The highest dose of resveratrol tested was 1 g by mouth twice daily. Patients who were treated with increasing doses of resveratrol over 12 months showed little or no change in amyloid-beta40 (Abeta40) levels in blood and cerebrospinal fluid. In contrast, patients taking a placebo had a decrease in Abeta40 levels compared to their levels at the beginning of the study.
Further studies, including analysis of frozen blood and cerebrospinal fluid taken from patients, are underway to test possible drug mechanisms.
Source.“Resveratrol Impacts Alzheimer's Disease Biomarker.” (2015, September 10). Retrieved October 2, 2015, from http://bit.ly/1QUgUsl.