EUCTR2004-002941-11-GB进行中（未招募）1 期
A multicentre, 3-month, randomised, double blind, placebo and active controlled study on the tolerability and efficacy of ZT-1 for the symptomatic treatment of mild to moderate Alzheimer’s Disease
Debiopharm SA0 个研究点目标入组 180 人开始时间: 2005年2月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with mild to moderately severe probable AD, diagnosed according to the DSM-IV and the criteria of NINCDS-ARDRA.
- •MMSE score at study entry ³12 and £ 26.
- •Patients should be aged >60 years.
- •Patients should be ambulatory and have a caregiver/informant willing to be present at each assessment.
- •Subjects should be physically able to carry out functional tasks.
- •Computed tomographic or magnetic resonance imaging to exclude other structural brain disease performed within 6 months before study start should support diagnosis of AD.
- •Patients must provide a written informed consent together with the caregiver.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of any disabling, severe or life-threatening disease (cardiac, respiratory, gastro-intestinal, neurological, epileptic, psychiatric, infectious, bone, endocrinologic).
- •Inability to discontinue at least 2 weeks prior to study start any medication listed as prohibited (see section 7.5.2 Prohibited medications).
- •Prior use of cholinesterase inhibitors.
- •Proven or clinically suspected other type of dementia such as vascular dementia, post-traumatic dementia, fronto-temporal dementia, dementia associated with Parkinson’s disease, infectious disease, (HIV, syphilis) folate or vitamin B12 deficiency, hypothyroidism etc.
- •Significant liver impairment : ASAT, ALAT ³ 3 times the upper normal limit.
- •Presence of cardiac rhythm disorder, in particular bradycardia or conduction abnormalities (ECG within normal limits at prestudy).
- •Uncontrolled arterial hypertension i.e. subjects with systolic BP ³160 mm Hg and/or diastolic ³100 mmHg, despite regular medication.
- •Significant kidney impairment: serum creatinine ³ 2 times the upper normal limit.
- •Any concomitant disorder or resultant therapy that is likely to interfere with subject compliance or with the study.
- •Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).
- •Known hypersensitivity to any of the test materials or related compounds.
- •Known active use of recreational drug or alcohol dependence, current alcohol abuse.
- •Inability to give written informed consent together with the caregiver or to comply fully with the protocol.
- •Subjects who, in the opinion of the Investigator, are considered unsuitable for any other reason.
研究者
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