A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

GlaxoSmithKline R&D Ltd0 个研究点目标入组 686 人2007年3月1日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: GlaxoSmithKline R&D Ltd
入组人数: 686
状态: 进行中（未招募）
最后更新: 14年前

概览研究者入排标准结局指标相似试验

概览

简要总结

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注册库

who.int

开始日期

2007年3月1日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

GlaxoSmithKline R&D Ltd

入排标准

入选标准

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1\.Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS\-ADRDA criteria for at least 3 months (Appendix 2\)
•2\.Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 26 inclusive at Screening.
•3\.Hachinski Ischemia Score \= 4 at Screening (See Appendix 3\).
•4\.Age \=50 and \=90 years.
•5\.Subject has not taken an approved Alzheimer’s therapy in the last 30 days.
•6\.Subject has not had a previous history of hypersensitivity or intolerance to AChEIs.
•7\.Current use of medication is in accordance with the criteria listed in Table 2 (Permitted Medications, Section 8\.1\).
•8\.Female subjects must be post\-menopausal (i.e. \>24 weeks without menstrual period), surgically sterile, or agree to use adequate method of contraception for the duration of the study. Female subjects who are pre\-menopausal or who have been post\-menopausal for \< 2 years must undertake pregnancy testing (urine test) at Visit 1, which must be negative.
•9\.Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease.

排除标准

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1\.Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS\-AIREN criteria (Appendix 4\).
•2\.History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
•3\.Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH) that is clinically significant in the opinion of the investigator.
•4\.History of Type 1 diabetes mellitus or secondary diabetes mellitus.
•5\.Type 2 diabetes mellitus where the subject is being treated with insulin, a PPAR? agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
•6\.Any patient with an HbA1c \=8\.5% (See Section 6\.3\.8\.4 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus).
•7\.History or clinical/laboratory evidence congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status; Appendix 5\).
•8\.History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome \[non Q\-wave myocardial infarction, Q\-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
•9\.History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM\-IV) in the past year, or current active depression requiring initiation of treatment .