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| Sponsored by: |
Blanchette Rockefeller Neurosciences Insitute |
| Information provided by: | Blanchette Rockefeller Neurosciences Insitute |
| ClinicalTrials.gov Identifier: | NCT00606164 |
Purpose
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 |
| ChemIDplus related topics: | 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
|
| 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
|
| 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
|
Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, West Virginia | |||||
| Chestnut Ridge Center West Virginia University Department of Behavioral Medicine and Psychiatry | Not yet recruiting | ||||
| Morgantown, West Virginia, United States, 26505 | |||||
| Contact: Eric Rankin, Ph.D. 304-293-5323 erankin@hsc.wvu.edu | |||||
| Principal Investigator: James M Stevenson, MD | |||||
| Blanchette Rockefeller Neurosciences Insitute |
| Principal Investigator: | James M Stevenson, MD | West Virginia University Department of Behavioral Medicine and Psychiatry |
More Information
| 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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