ISRCTN64846759
已完成
2 期
Prospective 24-week, double-blind, randomised, placebo-controlled, multicentre study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer?s type under treatment with increasing dosages of intravenous immunoglobulin (Octagam® 10%)
Octapharma AG (Switzerland)0 个研究点目标入组 56 人2009年1月28日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Alzheimer's disease (mild to moderate)
- 发起方
- Octapharma AG (Switzerland)
- 入组人数
- 56
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Probable Alzheimer's disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS\-ADRDA) criteria
- •2\. Written informed consent by patient or, for significantly cognitively impaired individuals, their legally authorised representative
- •3\. Aged greater than or equal to 50 and less than or equal to 85 years, either sex
- •4\. Mini\-mental State Examination (MMSE) greater than or equal to 16 and less than or equal to 26
- •5\. Only for Germany: the patient's capacity to consent has to be confirmed by dated signature on the informed consent form by a second independent investigator who is otherwise not involved in study GAM10\-04
- •6\. Modified Hachinski\-Rosen Score less than 5
- •7\. Magnetic resonance imaging (MRI) of the head consistent with the diagnosis of AD
排除标准
- •1\. Other causes of dementia (e.g. vascular dementia, Lewy Body dementia, fronto\-temporal dementia, Creutzfeld\-Jacob disease, Huntington's disease, Parkinson's disease)
- •2\. History of or present significant other diseases of the central nervous system (e.g. brain tumour, normal pressure hydrocephalus, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis)
- •3\. Geriatric depression scale of greater than 7 (short form with scale from 0 to 15\)
- •4\. Present significant psychiatric disorder (e.g. major depression)
- •5\. History of psychosis or hallucinations
- •6\. Mental retardation
- •7\. Unstable medical disease in the opinion of the investigator
- •8\. Insulin dependent diabetes mellitus
- •9\. Acute infectious disease
- •10\. Uncontrolled hypertension (diastolic blood pressure \[BP] greater than 90 mmHg or systolic BP greater than 160 mmHg; sitting)
结局指标
主要结局
未指定
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