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

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ClinicalTrials.gov Identifier: NCT00401921
Recruitment Status : Withdrawn (PI moved to a new facility)
First Posted : November 22, 2006
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Carotid Stenosis Drug: Minocycline Drug: Placebo oral capsule Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy
Study Start Date : October 2006
Primary Completion Date : June 2010
Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Minocycline arm
Minocycline 100mg/Placebo 0mg Minocycline 100mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery
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
Placebo Comparator: Placebo arm
Placebo 0mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.
Drug: Placebo oral capsule
1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.


Outcome Measures

Primary Outcome Measures :
  1. Neuropsychological assessment [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Joanne O'Hara, Sr. Project Manager, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00401921     History of Changes
Other Study ID Numbers: 2006-P-001225
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

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