Status:
WITHDRAWN
A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Carotid Stenosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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...
Detailed Description
This protocol is a phase IIa study that will prospectively investigate whether minocycline (an antibiotic that showed neuroprotective effects in animal models) can decrease the cognitive deficits asso...
Eligibility Criteria
Inclusion
- Patients with carotid stenosis 60% or more with a clinical indication of CEA.
- Patients that can perform the tests in English.
- 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).
- Ages Eligible for Study: 18 Years - 90 Years
- Genders Eligible for Study: Both
Exclusion
- Known hypersensitivity to tetracyclines
- Advanced cardiac, pulmonary or renal disease as assessed by the PCP of the patient.
- Previous strokes with important clinical neurological deficits.
- Pregnancy, breast-feeding or lactating
- Baseline MMSE score less or equal to 20.
- Female subjects on oral contraceptives.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00401921
Start Date
October 1 2006
End Date
June 1 2010
Last Update
July 14 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115