A Randomized, Placebo-Controlled Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Neuropsychological assessment
研究概览
简要总结
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.
详细描述
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 associated with carotid endarterectomy. This trial will be a randomized, parallel-group design, double-blind, placebo controlled clinical trial conducted at the Brigham and Women's Hospital.
The principal aim of this investigation is to study the effects of minocycline on cognitive performance after carotid endarterectomy. To measure cognitive function, we will perform a neuropsychological battery of tests (as detailed below). This battery of tests will be carried out by a blinded rater (a neurologist) and will be performed according to the following timetable:
Training session: before the baseline, patients will perform the tasks several times until they reach a stable plateau (defined as a variation of less than 10% in the last three trials) in order to eliminate the confounding effect of learning.
Baseline evaluation: the baseline evaluation will be performed in the day prior to the surgery.
Post-treatment evaluation: post-treatment evaluation will be performed 24 hours after the surgical procedure by the same blinded rater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Female subjects on oral contraceptives.
研究组 & 干预措施
Minocycline arm
Minocycline 100mg/Placebo 0mg Minocycline 100mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery
干预措施: Minocycline (Drug)
Placebo arm
Placebo 0mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Neuropsychological assessment
时间窗: 1 day
次要结局
未报告次要终点
研究者
Joanne O'Hara
Sr. Project Manager
Brigham and Women's Hospital