A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy
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.
|Study Design:||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|
- Neuropsychological assessment [ Time Frame: 1 day ]
|Study Start Date:||October 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00401921
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Robert Friedlander, MD||Brigham and Women's Hospital|