EUCTR2004-001187-52-LV进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled Trialto Evaluate the Safety and Efficacy of Two DifferentDosages of Phenserine-tartrate in Patients with Mild toModerate Probable Alzheimer’s Disease -Phenserine/APP and Aß
Axonyx Corporation0 个研究点目标入组 150 人开始时间: 2004年11月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •Signed informed consent by patient or the legally accepted representative prior to the
- •initiation of any study specific procedures
- •Male or female patients of at least 50 years of age
- •Probable Alzheimer’s Disease consistent with NINCDS-ADRDA criteria (Appendix 1).
- •MRI or CT scan within the last 12 months prior to baseline; findings consistent with the
- •diagnosis of probable Alzheimer’s Disease
- •Mini-Mental state examination score (MMSE) between 24 and 9 inclusive
- •Modified Hachinsky ischemic score equal or below 4
- •Female patients must be at least 2 years post-menopausal or surgically sterile
- •Caregiver available, if not living in the same household, caregiver sees patient at least 4 times a week
- •Patients living at home, old people’s home or an institutional setting without continuous
- •nursing care
- •General health status acceptable for a participation in a 6 month clinical trial
- •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
- •Violation of inclusion criteria not approved by clinical study director or study safety officer
- •Failure to perform or to evaluate screening or baseline examinations
- •Hospitalisation (except for study purposes or due to social reasons, e.g. hospitalisation to
- •unburden the caregiver) or change of concomitant medication 4 weeks prior to screening
- •or during screening period
- •Participation in another therapeutic clinical trial 3 months before baseline
- •Inability to swallow tablets
- •Unsubstituted vitamin B12 or folate deficiency
- •Serum electrolytes (sodium, potassium, magnesium) out of normal range
- •Unsubstituted hypothyroidism with TSH > 6,00 µU/ml
- •Juvenile onset diabetes mellitus
- •Adult onset diabetes mellitus insufficiently controlled (HbA1c > 8 %)
- •Renal insufficiency with serum creatinine > 2mg/dl
- •Severe hypotension requiring treatment with more than 2 drugs
- •Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by
- •clinical study director or study safety officer
- •Hypersensitivity to cholinergic drugs
- •Serious drug allergies
- •Malignant tumours within the last 5 years
- •Cardiovascular
- •Myocardial infarction or unstable angina within the last 6 months before screening
- •History of more than 1 myocardial infarction during the last 5 years
- •Cardiomyopathy
- •Myocarditis
- •Atrial fibrillation
- •Severe hypotension requiring treatment with more than 2 drugs
- •Severe hypertension requiring treatment with more than 2 drugs
- •Bradycardia (frequency of heart beat < 50/min.)
- •Tachycardia (frequency of heart beat > 90/min.)
- •Presence of AV block (type II / Mobitz II and type III)
- •Congenital long QT syndrome
- •Sinus node dysfunction
- •Prolonged QTcB-interval (males > 450 and females > 470 msec)
- •QTcB dispersion > 100 msec
- •Presence of U wave
- •Psychiatric
- •Episode of major depression in medical history
- •GDS score (15 item scale) > 5
- •History or presence of schizophrenia
- •Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs,
- •alcohol or industrial poisons
- •Neurological
- •Stroke within 6 months before screening or concomitant with onset of dementia
- •Tumours, subdural haematoma or other space occupying processes on CT/MRI
- •Head trauma with loss of consciousness within 1 year before or concurrent with onset of
- •Onset of dementia within 1 year following cardiac arrest, surgery with general anaesthesia
- •or resuscitation
- •Degenerative CNS disease, e.g. M. Huntington, Jacob-Creutzfeld disease, Downs
- •Wernickes encephalopathy
- •Acute or chronic CNS infection including tertiary syphilis
- 另有 17 项未显示
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