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2005年2月22日

概览

暂无简介。

注册库

who.int

开始日期

2005年2月22日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Debiopharm SA

•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

•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).