Memantine Treatment in Alzheimer's Disease Patients Stratified With Behavioral and Psychological Symptoms of Dementia (BPSD) Symptoms and Cognitive Severity: A Multi-center, Open-label, Parallel-group and Prospective Clinical Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 222
- 主要终点
- ADAS-cog change
研究概览
简要总结
The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD
详细描述
Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011[8];
- •Male or female, 50 years and older ;
- •All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
- •Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
- •Provide the informed consent.
排除标准
- •Patients with disturbance of consciousness of any causes;
- •Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
- •Patients with mental illness;
- •Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
- •Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
- •Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
- •Subjects who are unwilling or unable to abide by the study requirement.
研究组 & 干预措施
Mild AD
Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
干预措施: Memantine Hydrochloride (Drug)
Moderate AD
Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
干预措施: Memantine Hydrochloride (Drug)
Severe AD
Memantine Hydrochloride 20mg tablet per day by mouth on severe AD
干预措施: Memantine Hydrochloride (Drug)
结局指标
主要结局
ADAS-cog change
时间窗: ADAD-cog Change from baseline to 24 weeks
Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale
次要结局
未报告次要终点
研究者
Wei Cuibai
Professor, MD, PhD.
Xuanwu Hospital, Beijing