Neurotrope Concludes Patient Dosing, Monitoring in Clinical Trial of Bryostatin-1 for Alzheimer’s

Neurotrope Concludes Patient Dosing, Monitoring in Clinical Trial of Bryostatin-1 for Alzheimer’s
Neurotrope has finished dosing and monitoring patients in a Phase 2 clinical trial to evaluate Bryostatin-1, the company’s lead drug candidate for treatment of moderate to severe Alzheimer's disease. The randomized, double-blind, placebo-controlled, Phase 2 clinical trial (NCT02431468) is assessing the safety, tolerability and efficacy of bryostatin-1 in 148 people with Alzheimer's. Patients underwent a 12-week treatment with Bryostatin-1, followed by a 30-day post-treatment evaluation. The trial’s primary efficacy endpoint is the post-treatment change on the Severe Impairment Battery, a scale assessment widely used in Alzheimer’s drug trials. Secondary efficacy endpoints will include “Activities of Daily Living,” “Neuropsychiatric Inventory” and “Mini-Mental State Exam.” This study follows a now completed Phase 1/2 clinical trial (NCT02221947) that evaluated the preliminary safety, efficacy, biological effects and properties of Bryostatin-1 in 15 patients with Alzheimer's. Neurotrope CEO Susanne Wilke said she was "very pleased" with the study, which took only 13 months from start to finish. "A reversal of Alzheimer's progression would represent a major step forward in the treatment of Alzheimer's dementia patients after years of failed previous trials by other companies and institutions that predominantly targeted amyloid plaqu
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