The Safety and Efficacy of 1612 Capsules in Treatment of aMnestic Mild Cognitive Impairment: a 52-week, Double Blind,Randomized, Parallel,Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change from baseline to end of double-blind treatment of rate of dementia conversion from mild cognitive impairment
研究概览
简要总结
This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel trial which will be carried out in 15 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per day) or placebo for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination (MMSE), Delayed Story Recall test (DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be enrolled if they met the following criteria[14]:
- •cognitive complaints from the patients or their families;
- •objective evidence for memory impairment, delayed story recall test(DSR)<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10);
- •normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30);
- •preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52;
- •cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5;
- •absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria,
- •enough vision and hearing to accomplishment neuropsychological test;
- •capability to read words and write simple sentence;
- •capability and willingness to give informed consent and to comply with the study procedures.
排除标准
- •The patients would be ineligible if they had the following conditions:
- •non amnestic Mild cognitive impairment;
- •meeting the diagnostic criteria for dementia;
- •cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse
- •having significant psychiatric disease, depression, the Hamilton depression scale >12; CT or MRI scan showed central nervous system infections Infarction or focal lesions within 12 months，the Hachinski Ischemic Scale (HIS)>4;
- •combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;
- •used cholinesterase inhibitors or memantine within 1 month;
- •history of hypersensitivity to the treatment drugs;
- •concomitant drugs with the potential to interfere with cognition;
- •administration of other investigational drugs; severe impairment of the functions of the kidney or liver;
- •vegetarians or contraindications for animal innards.
研究组 & 干预措施
1612 capsule
Subjects will take 1612 capsule 3 capsules per time(0.38g per capsule), 3 times per day for 52 weeks
干预措施: 1612 capsule (Drug)
Placebos
Subjects will take palcebo identified to 1612 capsule 3 capsules per time, 3 times per day for 52 weeks
干预措施: Placebos (Drug)
结局指标
主要结局
Change from baseline to end of double-blind treatment of rate of dementia conversion from mild cognitive impairment
时间窗: 52 weeks
The rate of demention conversion will accessed from baselin at week 0 and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)
时间窗: 52 weeks
Cognition will accessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline (day 1 clinic visit) and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
次要结局
- Change from baseline to end of double-blind treatment of Mini-Mental State Examination(MMSE)(52 weeks)
- Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)(52 weeks)
- Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)(52 weeks)
研究者
Jinzhou Tian
Clinical Professor
Dongzhimen Hospital, Beijing