Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 24
- 主要终点
- Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
研究概览
简要总结
The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule.
详细描述
Alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. Research indicates that the disease is associated with plaques and tangles in the brain. Currently used treatments offer a small symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least primarily educated.
- •Accord with Probable Alzheimer disease of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA)'s Criteria.
- •10 points ≤ Minimum Mean-Square Error(MMSE) ≤ 24 points.
- •Hachinski ischemia scale <4 points.
- •Hamilton depression scale ≤10 points.
- •Should have stable accompanying person, or at least contact 2 hours per day, 4 days per week with accompanying person. The accompanying person should help the patient throughout the trial.
- •Signed the information consent form.
排除标准
- •Have been in other clinical trials within 30 days before this trial' start.
- •women during pregnancy or lactation.
- •Dementia caused by other diseases.
- •previous nervous system diseases.
- •Abnormal laboratory results.
- •Uncontrolled hypertension.
- •Unstable or serious diseases of heart, lung, liver, kidney and blood.
- •Visual or auditory handicap.
- •Significant focal lesions revealed by electronic computer X-ray tomography(CT) or magnetic resonance imaging(MRI) in one year before enrollment.
- •Alcohol abuse or drug abuse.
- •psychotic, including patients with serious depression.
- •Patients being in drug therapy of Alzheimer disease which cannot be stopped.
- •In treatment of heparin, Polysaccharide sulfate, mannose ester 3 weeks before the recruitment.
- •Investigator consider the patient cannot finish this trial for any reason.
- •Relatives or employees of the investigators, staff of the investigate centers, contract research organization and sponsor.
研究组 & 干预措施
sodium oligo-mannurarate 900mg
干预措施: Sodium oligo-mannurarate 900mg (Drug)
sodium oligo-mannurarate 600mg
干预措施: Sodium oligo-mannurarate 600mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
时间窗: 24 weeks
Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.
次要结局
- Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule(24 weeks)
- Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule(24 weeks)
- Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule(24 weeks)