NCT05041790尚未招募4 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment(ESCALADE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in patients with degenerative mild cognitive impairment.
详细描述
Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years
- •Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria
- •Diagnosed with mild cognitive impairment on SNSB
- •Delayed recall score of SVLT ≤ "average -1.5 standard deviation"
- •K-MMSE-2 score ≥ 24
- •The CDR score 0.5, and the memory item score 0.5 or 1 point
- •Patients with caregivers who are in regular contact, can visit together
- •Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
- •Sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure.
- •Written informed consent
排除标准
- •Diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis, Creutzfeld-Jacob disease), Pixie disease, Huntington's disease, Parkinson's disease, etc.)
- •Medication of dementia within the past three months
- •Brain functional improvement medication in the past six weeks.
- •Medication that may affect cognitive function during clinical trials
- •No studies (no regular school entrance), illiteracy
- •Significant neurological conditions (such as stroke, multiple sclerosis, severe head trauma with loss of consciousness, cerebral palsy, cerebral tumor, cerebral infarction, spinal infarction or central nervous system infection) and/or evidence (CT or MRI results performed within the past 12 months or during screening)
- •Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
- •Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
研究组 & 干预措施
Choline Alfoscerate
Experimental
干预措施: Choline Alfoscerate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
时间窗: Baseline to 48 weeks
Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score
次要结局
- The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline(Baseline to 24 weeks)
- The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The proportion of subjects increased by more than or equal to 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The change of CDR-SB score at 48 weeks compared to baseline(Baseline to 48 weeks)
研究者
研究点 (1)
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