Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy
This study is currently recruiting participants.
Verified by Brigham and Women's Hospital, April 2007
Sponsored by: Brigham and Women's Hospital
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00401921
  Purpose

The primary aim of this protocol is to investigate a possible new, neuroprotective treatment to prevent cognitive deficits that occur after carotid endarterectomy. We will investigate whether a widely used antibiotic agent – minocycline - that has shown neuroprotective effects in animal models of neurological diseases – can reduce the cognitive deficits associated with the surgical procedure of carotid endarterectomy (CEA). Because these cognitive deficits are believed to be a result of small strokes (due to emboli and/or hypoperfusion), this study will provide preliminary data on the use of this drug as a neuroprotective agent in stroke – a leading cause of disability.

(1) The first aim of this study is to examine whether 5 doses of minocycline administered 36 hrs before and 1 dose 12 hrs after the surgical procedure in patients undergoing CEA are effective to reduce the cognitive deficits associated with this procedure as compared with placebo.

a. The null hypothesis is that there is no difference in cognitive performance changes after CEA between the patients that receive placebo or minocycline.


Condition Intervention Phase
Carotid Stenosis
 Drug: Minocycline
 Phase II

Drug Information available for: Minocycline Minocycline hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized, Placebo-Controlled Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy

Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 40
Study Start Date: October 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with carotid stenosis 60% or more with a clinical indication of CEA.
  2. Patients that can perform the tests in English.
  3. Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test (adequate birth control includes use of intra uterine device, or a barrier method, e.g. condom, diaphragm).
  4. Ages Eligible for Study: 18 Years - 90 Years
  5. Genders Eligible for Study: Both

Exclusion Criteria:

  1. Known hypersensitivity to tetracyclines
  2. Advanced cardiac, pulmonary or renal disease as assessed by the PCP of the patient.
  3. Previous strokes with important clinical neurological deficits.
  4. Pregnancy, breast-feeding or lactating
  5. Baseline MMSE score less or equal to 20.
  6. Female subjects on oral contraceptives.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401921

Contacts
Contact: Joanne O'Hara, MA 617-732-6992 JOHARA1@PARTNERS.ORG

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joanne O'Hara, MA     617-732-6992     JOHARA1@PARTNERS.ORG    
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Robert Friedlander, MD Brigham and Women's Hospital
  More Information

Study ID Numbers: 2006-P-001225
Study First Received: November 17, 2006
Last Updated: April 3, 2007
ClinicalTrials.gov Identifier: NCT00401921  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Arterial Occlusive Diseases
Carotid Stenosis
Minocycline
Vascular Diseases
Central Nervous System Diseases
 Constriction, Pathologic
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
 Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services