drugset / Trial / NCT00401921

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

NCT00401921

Phase 2 Withdrawn Brigham and Women's Hospital
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2006-10
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Minocycline Small molecule 100 mg Oral

Indications