drugset / Trial / NCT03560245

A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine

NCT03560245

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized double-blind Placebo-controlled, Phase 2 study comparing bryostatin to placebo for the treatment of moderately severe to severe Alzheimer's disease in subjects not receiving memantine treatment. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug. Subjects will receive 7 doses of study drug during the study. The primary efficacy endpoint is defined as the change from baseline to Week 13 in the Severe Impairment Battery (SIB) total score.

Timeline

Start
2018-06-20
Primary completion
2019-07-25
Completion
2019-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject bryostatin 1 Small molecule 20 ug Intravenous

Indications