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Sponsored by: |
Blanchette Rockefeller Neurosciences Insitute |
Information provided by: | Blanchette Rockefeller Neurosciences Insitute |
ClinicalTrials.gov Identifier: | NCT00606164 |
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.
Condition | Intervention | Phase |
Alzheimer's Disease |
Drug: Bryostatin for Injection Drug: Placebo |
Phase II |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Disease |
Drug Information available for: | Sodium chloride Chlorides Bryostatin 1 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bryostatin 1 in Patients With Mild to Moderate Alzheimer's Disease |
Estimated Enrollment: | 9 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo: Placebo Comparator |
Drug: Placebo
A single one-hour intravenous infusion of placebo on Day 1
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10 ug/m2 Bryostatin: Experimental |
Drug: Bryostatin for Injection
A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1
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15 ug/m2 Bryostatin: Experimental |
Drug: Bryostatin for Injection
A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, West Virginia | |||||
Chestnut Ridge Center West Virginia University Department of Behavioral Medicine and Psychiatry | |||||
Morgantown, West Virginia, United States, 26505 |
Blanchette Rockefeller Neurosciences Insitute |
Principal Investigator: | James M Stevenson, MD | West Virginia University Department of Behavioral Medicine and Psychiatry |
Responsible Party: | Blanchette Rockefeller Neurosciences Insitute ( Mark A. Cochran, Ph.D./CEO and Executive Director ) |
Study ID Numbers: | BRY-201 |
First Received: | January 21, 2008 |
Last Updated: | January 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00606164 |
Health Authority: | United States: Food and Drug Administration |
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