EUCTR2006-003616-21-DE进行中（未招募）不适用
Prospective, single-arm, multi-center, open-label study to investigate the efficacy and tolerability of the once daily [OD] memantine treatment
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 119
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 prior to the initiation of any study specific procedures
- •- Male or female outpatient at least 50 years of age and at least 8 years of education
- •- Patient has German as mother-tongue or at least speaks the language fluently
- •- Patient has a current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria and with DSM IV TR criteria for Dementia of the Alzheimer’s type
- •- Communication difficulties, which are judged by a physician to be closely related to the diagnosis of Alzheimer’s disease
- •- Alzheimer’s disease confirmed by Magnet Resonance Imaging [MRI], or Computer Tomography [CT] scan within the past 12 months before study entry or MRI conducted at screening
- •- Patient’s MMSE total score is less than 20
- •- Patient has a knowledgeable and reliable carer who will accompany the patient to all clinic visits during the course of the study
- •- Patient’s concomitant treatment is in accordance to Study Protocol 9.4.7.1 and Appendix A
- •- If female, the patient is at least 2 years post menopausal or surgically sterile
- •- Patient’s sight and hearing is sufficient to undertake the study-related procedures and psychometric tests without difficulty
- •- The Investigator believes that the patient will be capable of completing all study-related psychometric tests during the study
- •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
- •- Patient with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
- •- Patient has a recent history (within 3 months prior to screening), or currently untreated, B12, thyroidea stimulating hormone [TSH] or folate deficiency, which is considered clinically significant
- •- Patient with evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer’s disease
- •- Patient has a Modified Hachinski Ischemia score greater than 4 at screening
- •- Patient with current evidence of clinically significant, unstable psychiatric illness (other than symptoms associated with Alzheimer’s disease) including, psychotic disorders and bipolar or unipolar depression
- •- Patient has an oncological diagnosis (hematological or solid tumor) which is currently being treated or there is still evidence of active disease
- •- Patient has a history of severe drug allergy, hypersensitivity, or known hypersensitivity to amantadine and lactose
- •- Patient has a known or suspected history of alcoholism or drug abuse within the past 10 years
- •- Patient has participated in an investigational drug study, or has received treatment with an investigational drug within 90 days (or 5 half-lives, whichever is longer) prior to the screening visit
- •- Patient has been previously treated with memantine or has participated in an investigational study of memantine
- •- Patient has any disease or treatment which according to the investigator’s judgment, could interfere with the assessments of safety, tolerability or efficacy
- •- Patient, or patient with her/his carer, are unwilling, or unable to abide by the visit schedule and other study requirements
- •- Patient has any type of evident aphasia, which may interfere with patient’s communication difficulties caused by Alzheimer’s disease
研究者
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