NCT00285025已完成2 期
A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 500
- 主要终点
- ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
研究概览
简要总结
The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD.
Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.
详细描述
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male / female outpatients.
- •Age > 50 years at screening.
- •Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score > 12 and <
- •Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
- •Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
- •Presence of a reliable caregiver.
- •Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures
排除标准
- •Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
- •Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
- •Females who are pregnant or breast-feeding. Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit, and must use an acceptable method of birth control.
- •Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
- •Use of CYP3A4 strong inhibitors
- •Evidence (detected by history, physical examination and / or laboratory / ECG tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
结局指标
主要结局
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
次要结局
- MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.
研究者
相似试验
已完成
2 期
Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's DiseaseParkinson DiseaseNCT00228150Sanofi564
已完成
2 期
Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's DiseaseParkinson DiseaseNCT00220272Sanofi183
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of ProgressionNCT05797610Hoffmann-La Roche459
已完成
2 期
Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes MellitusDiabetes MellitusNCT00760344Takeda386
撤回
2 期
Safety and Efficacy of 4-weeks Treatment of BIBW 2948 BS in Patients With Chronic Obstructive BronchitisPulmonary Disease, Chronic ObstructiveBronchitis, ChronicNCT00726479Boehringer Ingelheim