A Double-Blind, Crossover Trial of Aricept® in Memory-Impaired Patients With Multiple Sclerosis: A Phase IV Demonstration of Functional MRI (fMRI) as a Surrogate Marker of Brain Activity Associated With Improvement in Memory Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Anatomic relationships during cognitive activity, and how these relationships change as a function of drug
研究概览
简要总结
The purpose of this study is to determine if medication designed to improve memory will help patients with Multiple Sclerosis (MS) who are experiencing memory problems using fMRI to track brain activity.
详细描述
Donepezil HCI (Aricept®) is an FDA-approved drug now used to enhance memory in patients with Alzheimer's disease. The aim of this project is to examine the effects of Donepezil HCI (Aricept®) on memory induced brain activation patterns in the context of a double-blind, crossover trial of patients with multiple sclerosis (MS). We will perform task activation experiments involving two cognitive domains. The proposed work on MS patients should yield new information regarding functional anatomic relationships during cognitive activity, and how these relationships change as a function of drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years of age and experiencing some forgetfulness
- •Diagnosed with MS, currently taking Rebif® and experiencing mild memory problems
- •Participants will have stable medication dosages 1 month prior to testing
- •With no past or present neurological disorders (e.g. head trauma, seizures, encephalitis, stroke) except MS
- •With no known medical illnesses (e.g. diabetes, uncontrolled hypertension, arthritis)
- •With no psychiatric illness
- •With no current substance abuse
- •Females should not be pregnant or nursing
- •With no metallic devices in the body or claustrophobia
排除标准
- •Previous history of CNS disturbance other than MS
- •Severe motor or visual impairment that might interfere with the cognitive activation tasks
- •Prescribed psychoactive medications
- •Memory deficits caused by other significant neurological disease or psychiatric disorder
- •Active malignancy within one year of study participation
- •Known human immunodeficiency virus (HIV)
- •Current diagnosis of unstable glaucoma; history of myocardial infarction
- •Symptomatic Coronary Artery Disease within the last 12 months or evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG; poorly controlled or labile hypertension
- •History of epilepsy or other seizure disorder within the past 12 months
- •Allergy or hypersensitivity to amphetamines or other sympathomimetic amines
结局指标
主要结局
Anatomic relationships during cognitive activity, and how these relationships change as a function of drug
次要结局
- fMRI as a surrogate marker for drug efficacy