Neurotrope’s Bryostatin Appears to Improve Cognition in Patients with Moderate to Severe Alzheimer’s

Neurotrope’s Bryostatin Appears to Improve Cognition in Patients with Moderate to Severe Alzheimer’s
Neurotrope's investigational drug bryostatin might improve cognition and the ability of patients with moderate to severe Alzheimer's disease to care for themselves, according to a Phase 2 trial. The placebo-controlled trial (NCT02431468) evaluated the safety, tolerability, and effectiveness of bryostatin in 147 people with Alzheimer's disease (AD). Patients underwent a 12-week treatment with two dose levels of bryostatin (20 or 40 micrograms) or a placebo, followed by a post-treatment evaluation at week 13. The primary efficacy endpoint of the study was the post-treatment change on the Severe Impairment Battery (SIB), an assessment scale widely used in Alzheimer’s drug trials to evaluate dementia. Two sets of patients were evaluated: all patients who received bryostatin and had at least one efficacy/safety evaluation at 13 weeks, called the modified intent-to-treat (mITT) population; and patients in the previous group and who completed the 13-week evaluation (completer population). Results reported by Neurotrope indicate that bryostatin (20 micrograms), administered every two weeks, met the pre-specified primary endpoint in the completer population, but not in the mITT population. This means that among the 113 patients who completed the protocol, those who were treated with bryostatin saw an improvement in the SIB scale compared to those treated with a placebo. However, while the 90 patients in the mITT population had a
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