NCT00624026已完成3 期
Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score
研究概览
简要总结
The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatient at least 50 years of age and at least 8 years of education.
- •The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
- •Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
- •Mini Mental State Examination (MMSE) total score is less than 20
- •Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months.
排除标准
- •Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
- •History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
- •Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
- •Modified Hachinski Ischemia score greater than 4 at screening.
- •Current evidence of clinically significant systemic disease
- •Known or suspected history of alcoholism or drug abuse within the past 10 years.
- •Previous treatment with memantine or participation in an investigational study with memantine.
研究组 & 干预措施
1
Experimental
干预措施: Memantine-HCl (Drug)
结局指标
主要结局
To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effect of Memantine on Functional Communication in Patients With Alzheimer's DiseaseAlzheimer's DiseaseNCT00469456Forest Laboratories265
已完成
1 期
Memantine effect on patients with schizophreniaSchizophrenia.SchizophreniaIRCT20190606043827N1Kashan University of Medical Sciences50
已完成
3 期
Study on Cognitive Disorders of Multiple SclerosisMultiple SclerosisNCT01074619University Hospital, Caen90
已完成
3 期
Effect of Memantine on epileptic patientsEpilepsy.Epilepsy and recurrent seizuresIRCT20121110011424N5Tehran University of Medical Sciences60
已完成
2 期
Effectiveness of Memantine in improvement of cognitive deficits in specific learning disorderspecific learning disorder.Developmental disorder of scholastic skills, unspecifiedIRCT2015102124633N1Vice Chancellor for research of Arak University of Medical Sciences94