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Neurotrope Provides Corporate Update After Completing Bryostatin-1 Data Analysis for Advanced Alzheimer's Disease Trial
Analysis to adjust for significant baseline imbalance in Severe Impairment Battery scores between treatment groups shows improvement in cognitive function of
About this update from Nexttrip, Inc.
[{"type":"text","content":"Analysis to adjust for significant baseline imbalance in Severe Impairment Battery scores between treatment groups shows improvement in cognitive function of pre-specified Moderate Stratum patients at week 13, the primary endpoint\n National Institute of Health awards $2.7 million grant to Neurotrope to conduct additional clinical research for patients with advanced Alzheimer's disease\n Company continues to explore strategic alternatives\n\n\nNEW YORK, Jan. 22, 2020 /PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP) (\"Neurotrope\" or the \"Company\"), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, today announced its corporate update.\nThe Company has completed analysis of the data (Clinical Study Report) from its recently reported Phase 2 confirmatory clinical trial (the \"203 study\"), examining moderately severe to severe Alzheimer's disease patients treated with Byrostatin-1 in the absence of memantine / Namenda.\n\"A significant imbalance (4.8 points) in the baseline Severe Impairment Battery (\"SIB\") scores occurred, by chance, between the Bryostatin-1 treatment group and placebo group,\" stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer. \"After consulting with our Scientific Advisory Board and statistical experts, we were advised that, in a small study such as this, a baseline imbalance could prevent a definitive analysis of Bryostatin-1 treatment versus placebo in SIB scores at the primary (Week #13) and secondary endpoints as provided in the original Statistical Analysis Plan (\"SAP\"),\" stated Dr. Alkon. \n\"Due to the baseline imbalance observed in the study, and because a clear signal of benefit could be observed in the raw data from the pre-specified Moderate Stratum, we conducted a post-hoc analysis using paired data for individual patients, with each patient as his/her own control,\" stated Kazem Kazempour, Chief Executive Officer of Amarex, Inc., the biostatistician retained to analyze the data from the 203 study under the SAP. For the pre-specified Moderate Stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseli...