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A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy

This study has been terminated.
(PI moved to a new facility)
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00401921
First received: November 17, 2006
Last updated: June 22, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Neuropsychological assessment [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: October 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Minocycline
    100 mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery
    Other Name: Minocycline 100mg/Placebo 0mg
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401921

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Robert Friedlander, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Robert Friedlander, MD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00401921     History of Changes
Other Study ID Numbers: 2006-P-001225
Study First Received: November 17, 2006
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014