Trial intelligence / Profile preview

Bryostatin in Moderately Severe Alzheimer's Disease

NCT04538066Phase 2

Key facts

Status: Completed
Start: Aug 2020
Primary completion: Nov 2022
Countries: 1
Sponsor: Synaptogenix, Inc.
Modality: Small Molecules

Drugs: bryostatin-1
Conditions: Alzheimer's disease (AD)

Overview

Phase 2, randomised, double-blind trial in Alzheimer's disease (AD) comparing Bryostatin 1 with Placebo (2 arms). Primary endpoints: Severe Impairment Battery Total Score at 28 weeks and Adverse Events and Serious Adverse Events at 42 weeks. Started Aug 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Bryostatin 1
Bryostatin 1 (20ug IV) administered in two courses.
Placebo
Matching Placebo IV administered in two courses.

Who it enrols

Patients with probable Alzheimer's disease, MMSE-2 10-18, SIB 60-93, not receiving memantine.

Endpoints

Primary

Severe Impairment Battery Total Score28 weeks
Adverse Events and Serious Adverse Events42 weeks

Secondary

Severe Impairment Battery Total Score at Follow-up42 weeks
Change From Baseline in SIB Total Score30 weeks
SIB Trends Over Time28 weeks

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