Byrostatin Improves Cognition in Advanced Alzheimer Disease 

An article published in the Journal of Alzheimer Disease provides evidence from 2 placebo-controlled trials that bryostatin (DB11752; Synaptogenix Inc., New York, NY) improved cognition from baseline in individuals with advanced Alzheimer diseae (AD).

Prespecified exploratory analyses for the individual trials and the pooled trials confirmed significant bryostatin-induced improvement over baseline (treatment P<0.001, placebo not significant). An increased power (n=95) pooled analysis showed an increased Severe Impairment Battery (SIB) over time and a higher mean SIB at 13 weeks in the bryostatin treatment group (P< .001) but not significant for the participants treated with placebo. 

Participants with Mini-Mental State Examination scores of 10-14, treated with bryostatin without memantine, showed baseline balance, complete safety, and SIB improvements at 13 that were 4.1 SIB points above baseline (P= 0.005) and 4.2 SIB points above baseline (P=.016).

"Rigorous statistical analyses, including a pooled testing of identical prespecified cohorts in 2 separate trials, revealed highly significant (P<.001) benefit of bryostatin treatment of AD patients in the absence of the dementia treatment memantine. Blinded placebo controls in these trials allow for the exclusion of the placebo effects that so often accompany early testing of candidate drugs to treat AD," stated Dr. Daniel Alkon, MD, president and chief scientific officer. "Importantly, we believe that the peer-reviewed data in our manuscript has provided additional justification for our continued grant support from the National Institutes of Health (NIH) for our ongoing phase 2b clinical trial."

Alan Tuchman, MD, chief executive officer, commented, "The power of these results, enhanced by appropriate pooling of prespecified cohorts, provides encouragement that our 6-month trial will confirm bryostatin effective treatment of the underlying degenerative progression of AD, a claim that other therapeutic strategies have struggled to demonstrate to date."

With the 2 double-blind placebo-controlled bryostatin phase 2 trials, researchers for the study aimed to conduct exploratory statistical analyses of participants with identical conditions of enrollment and treatment.