EUCTR2006-005161-18-GB进行中（未招募）1 期
A randomised, double-blind, double-dummy, oral donepezil controlled study on the safety and efficacy of repeated monthly subcutaneaous injections of a sustained-release implant of ZT-1 in patients with moderate Alzheimer’s Disease (AD)
Debiopharm0 个研究点目标入组 128 人开始时间: 2008年2月28日最近更新:
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
- 128
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
- •1.Presence of moderately severe probable AD, diagnosed according to the DSM-IV and the NINCDS ADRDA criteria;
- •2.MMSE score = 14 and = 22;
- •3.Male/female patient aged > 50 years; female patients should be of no child-bearing potential or postmenopausal (at least one year after last menses);
- •4.Body mass index (BMI) between 18 and 29 kg/m2 inclusive;
- •5.Has a caregiver , is living at home or in an assisted living facility , is able to attend ambulatory study visits;
- •6.Naïve to donepezil;
- •7.Has discontinued another AChEI and/or memantine at least 3 months prior to study visit 2 (Day 1);
- •8.Has a computed tomographic (CT) or magnetic resonance imaging (MRI) scan excluding another structural brain disease and supporting diagnosis of AD; CT or MRI scan must have been performed within 6 months prior to visit 2 (Day 1);
- •9.Fluent in English (mother tongue or working language);
- •10.Able to communicate well with the Investigator;
- •11.Physically able to carry out functional tasks;
- •12.Has given 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
- •1.Presence of any disabling, severe or life-threatening disease (cardiac, respiratory, gastro intestinal, neurological, epileptic, psychiatric, infectious, bone, endocrinologic);
- •2.Inability to discontinue at least 2 weeks prior to visit 2 (Day 1) (or within 5 drug half-lives, whichever is longer) any medication listed as prohibited:
- •a.All cholinergic” medications, other than AChEI, including anticholinergics, cholinomimetics; antihistamines; sympaticomimetics;
- •b.Muscle relaxants such as suxamethonium;
- •c.Any psychotropic drugs except those deemed necessary by the Investigator (i.e. emergency use);
- •3.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 (human immunodeficiency virus [HIV], syphilis), folate or vitamin B12 deficiency, hypothyroidism etc.;
- •4.Significant liver impairment with aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) =3x the upper normal limit at screening;
- •5.Significant kidney impairment with serum creatinine = 2x the upper normal limit at screening;
- •6.Presence of cardiac rythm disorder, in particular bradycardia (< 60 bpm), conduction abnormalities such as AV block; presence of active ischaemia (such as unstable angina pectoris) or recent myocardial infarction, QT interval = 450 msec at screening, QRS complex = 110 msec at screening (ECG must be within normal limits at screening);
- •7.Uncontrolled arterial hypertension i.e. patients with systolic blood pressure (BP) = 160 mmHg and/or diastolic = 100 mmHg, at screening despite regular medication;
- •8.Uncontrolled arterial hypotension, i.e. patients with systolic BP = 100 mmHg and/or presenting a fall of systolic BP = 20 mmHg or a fall of diastolic BP = 10 mmHg after the 2 minutes (min) Schellong test at screening (see Appendix A: Schellong Test);
- •9.Any concomitant disorder or resultant therapy that is likely to interfere with patient compliance or his/her participation to the study;
- •10.Participation in another study with an experimental drug within 3 months before study visit 2 (Day 1) or within 5 drug half-lives of the investigational drug (whichever is the longer);
- •11.Known peripheral cholinergic intolerance, i.e. with previously prescribed AChEI(s);
- •12.Known hypersensitivity to any of the test materials or related compounds, including lactose, present in the donepezil and placebo capsules;
- •13.Known active use of recreational drug or alcohol dependence, current alcohol abuse;
- •14.Inability to comply fully with the protocol;
- •15.Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason.
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