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 人开始时间: 2009年1月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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)
- •11. Symptomatic stroke
- •12. Transient ischaemic attack (TIA) within preceding 2 years
- •13. Participation in other drug trial currently or within the previous 3 months before screening
研究者
相似试验
进行中（未招募）
不适用
Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter 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%)mild to moderate Alzheimer´s diseaseEUCTR2007-007134-19-DEOctapharma AG56
进行中（未招募）
不适用
Efficacy of strontium ranelate versus placebo in postmenopausal osteoporotic women previously treated with bisphosphonates.EUCTR2011-000708-17-ATInstitut de Recherches Internationales Servier160
进行中（未招募）
不适用
Efficacy of strontium ranelate versus placebo in postmenopausal osteoporotic women previously treated with bisphosphonates.Postmenopausal osteoporotic womenMedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-000708-17-BEInstitut de Recherches Internationales Servier160
进行中（未招募）
不适用
Efficacy of strontium ranelate versus placebo in postmenopausal osteoporotic women previously treated with bisphosphonates.EUCTR2011-000708-17-DEInstitut de Recherches Internationales Servier160
进行中（未招募）
不适用
Efficacy of strontium ranelate versus placebo in postmenopausal osteoporotic women previously treated with bisphosphonates.EUCTR2011-000708-17-HUInstitut de Recherches Internationales Servier160