Amended FDA Protocol Submitted for Phase 2b Trial of Advanced Alzheimer’s Therapy

Amended FDA Protocol Submitted for Phase 2b Trial of Advanced Alzheimer’s Therapy
NeurotropeNeurotrope BioScience has submitted an amended protocol to the U.S. Food and Drug Administration (FDA) for a Phase 2b clinical trial of its lead product candidate bryostatin-1 for treating advanced Alzheimer's disease. The company said in a press release that in the original trial protocol, the primary efficacy outcome is at week 13, unchanged with this amendment, and the trial's primary efficacy endpoint remains based on the Severe Impairment Battery scale assessment that is widely used in Alzheimer's disease drug trials. Secondary efficacy endpoints will include "Activities of Daily Living," "Neuropsychiatric Inventory," and "Mini-Mental State Exam." However, under the amendment submitted, Neurotrope BioScience -- a subsidiary of New York-based Neurotrope Inc. -- now expects to be able to report top-line trial data in the early spring of 2017. The clinical trial's original protocol was designed to evaluate the safety and efficacy of bryostatin-1 compared to a placebo at two doses -- 20 micrograms or 40 micrograms, which would be followed by seven doses administered over a 12-week period and a primary efficacy evaluation at week 13. A second study interval of 12 weeks was to immediately follow the 13-week primary evaluation for exploratory purposes, with patients in the groups receiving bryostatin-1 re-randomized to receive either dose while patients in the placebo arm were re-randomized to receive either 10 micrograms of bryostatin-1 o
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