Overview

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

Status:
Withdrawn

Trial end date:
2010-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Brigham and Women's Hospital

Treatments:

Minocycline

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.