EUCTR2006-000860-10-BE进行中（未招募）1 期
An Open-Label Study Investigating the Specific Effects of Memantine in Institutionalised Patients with Alzheimer’s Disease - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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. Written informed consent must be obtained from the patient and a relative or a legally acceptable representative prior to the initiation of any study specific procedures.
- •2. The patient has a diagnosis of Dementia of the Alzheimer’s type consistent with DSM-IV-TR Criteria, established before entering the nursing home and recorded in the patient’s medical records.
- •3. Duration of residency of at least 3 months in the present nursing home prior to enrolment into the study.
- •4. The patient’s The Functional Assessment Staging (FAST) is 5-6e (both inclusive) at screening.
- •5. The patient exhibits >0 score on the Neuropsychiatric Inventory – Nursing Home version (NPI-NH) sub-items 1, 2, or 3 (delusions, hallucinations, and agitation/aggression) at screening.
- •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. Patients with a DSM-IV Axis I disorder other than AD, including other primary causes of dementia, amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
- •2. Patients who are taking any unapproved concomitant medications according to the specified list in the protocol that cannot be discontinued.
- •3. Patients who have been previously treated with memantine within 6 months prior to entrance into this study.
研究者
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