NCT02553928已完成4 期
Interventional, Randomised, Double-blind, Study to Evaluate the Safety and Tolerability of Once Daily Versus Twice Daily Memantine Treatment in Patients With Dementia of Alzheimer's Type and MMSE Range 5 - 18
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Adverse Events
研究概览
简要总结
Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
- •The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- •The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
- •The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening
排除标准
- •The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
- •The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
- •The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Memantine (once daily)
Experimental
Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
干预措施: Memantine (once daily) (Drug)
Memantine (twice daily)
Experimental
Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
干预措施: Memantine (twice daily) (Drug)
结局指标
主要结局
Adverse Events
时间窗: baseline to week 16 (end of study)
Number of patients who reported adverse events
次要结局
- ADCS - CGIC Score at Week 12(ADCS - CGIC score at Week 12)
研究者
研究点 (6)
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