Positive Preliminary Phase 2 Clinical Trial Results for Bryostatin as Treatment for Alzheimer’s Disease
At the 11thEdition of Clinical Trials on Alzheimer’s Disease (CTAD) interim results were shared from a phase 2 trial (NCT03560245) evaluating the use of bryostatin (Neurotrope, Princeton, NJ) for treatment of people with AD. Patients with moderate to severe AD who were not taking memantine and were treated with 20 mcg bryostatin intravenously, every 2 weeks for 15 weeks, had improvements in their Severe Impairment Battery (SIB) scores (> 6.3 points). Analysis of individual patients’ scores over time showed that 15 of the 16 who completed 15 weeks of bryostatin treatment without memantine had improved SIB scores. Trend analysis using the model for repeated measures (MMRM) statistical test suggests that bryostatin treatment in the absence of memantine may have significant effects on patient’s SIB scores compared to bryostatin with memantine or placebo with or without memantine (Figure).
"We are encouraged by the findings of this exploratory trial as we believe they are suggestive of the primary mechanisms of action of bryostatin, synaptogenesis, and anti-apoptosis, or the generation of new, mature synaptic connections and the prevention of neuronal death," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "These results show a potential reversal of disease progression occurring in patients with moderate to severe AD treated with bryostatin-1. Notably, this improvement persisted even 30 days after completion of all drug administration."