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Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Study of Bryostatin 1 in Patients With Alzheimer's Disease

NCT00606164 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2008-02-01

No results posted yet for this study

Summary

The main purpose of this study is find out how safe a single dose of bryostatin 1 is in patients with Alzheimer's Disease (AD). This study is also being done 1) to determine how effective a single dose of bryostatin 1 is in the treatment of AD, 2) to find out what happens to bryostatin 1 once it enters the body by measuring the levels of bryostatin 1 in blood, and 3) to measure a substance in the blood (protein kinase C) that may help to better understand how bryostatin 1 works.

Conditions

Interventions

DRUG

Bryostatin for Injection

A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1

DRUG

Placebo

A single one-hour intravenous infusion of placebo on Day 1

Sponsors & Collaborators

  • Blanchette Rockefeller Neurosciences Insitute

    lead OTHER

Principal Investigators

  • James M Stevenson, MD · West Virginia University Department of Behavioral Medicine and Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00606164 on ClinicalTrials.gov