CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
Bryostatin 1 +1 moredrug
Likely dose
Bryostatin 1 20 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04538066
NCT04538066Phase 2Completed
CompareCT.gov

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

Neurotrope Bioscience, Inc.·interventional·Posted Sep 3, 2020·Updated Jul 31, 2024

In Brief

A Phase 2 clinical trial evaluating Bryostatin 1 and Placebo for Alzheimer Disease. Completed, enrolled 122 participants across 19 sites.

Detailed Summary

To evaluate the safety, tolerability, and long-term efficacy of bryostatin 1 (hereafter referred to as bryostatin) for the treatment of moderately severe Alzheimer's disease (AD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute on Aging (NIA)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 3, 2020
Enrollment StartAug 30, 2020
Primary CompletionNov 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.8 years ago

Interventions

Bryostatin 1drug

Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course.

Placeboother

Placebo administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course.