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

NCT03560245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-10-01

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

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

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Neurotrope Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan Tuchman, MD · Neurotropebioscience, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2019-07-25
Completion
2019-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560245 on ClinicalTrials.gov