NCT03560245

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease Subjects Not Receiving Memantine Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Neurotrope Bioscience, Inc. · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects will be stratified based on Mini Mental State Exam (MMSE-2) scores 4-9 vs. 10-15 and will be randomized 1:1 to one of two treatment arms: 20µg bryostatin or placebo for twelve weeks. The first two doses of study drug will be a loading dose 20% higher (i.e., 24µg) than the assigned dose and will be administered one week apart. Thereafter, the assigned dose of 20µg will commence with the third dose and be administered every other week. Drug is administered IV by continuous infusion over 45(±5) minutes. Subjects are scheduled to receive seven doses over 12 weeks.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Bryostatin	The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
OTHER	Placebo	The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug

Timeline

• Start date: 2018-06-20
• Primary completion: 2019-07-25
• Completion: 2019-07-25
• First posted: 2018-06-18
• Last updated: 2020-10-01
• Results posted: 2020-10-01

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study