A 12-month Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12).
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age range : 50 - 80 years old.
- •Informed consent signed and dated by patient or legal representative.
- •The participants are mild-to-moderate AD patients who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months. If participants lack previous pathological evidence or biomarkers of Alzheimer's dementia, they must have evidence of β-amyloid deposition biomarkers during screening (PET with abnormal amyloid deposition or low cerebrospinal fluid Aβ 42 and Aβ 42/Aβ 40 ratio).
- •MMSE score 11 to 26;CDR-GS score 1 to 2 。
排除标准
- •Participants with non AD induced memory and cognitive impairment, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease related dementia, frontotemporal lobe dementia (FTD), etc; Endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by folate, vitamin B12 deficiency, or any other reason; Existence of consciousness disorders, etc.
- •Participants have a history of epileptic seizures.
- •Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium.
- •HAMD-17 score ≥ 17 points.
- •HAMA score ≥ 14 points.
- •Participants were taking antidepressants, anxieties, and antipsychotic drugs during screening.
- •HIS score ≥ 4 points..
研究组 & 干预措施
Wujia Yizhi Granules
Participants received Wujia Yizhi Granules 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months.
干预措施: Wujia Yizhi granules (Drug)
Placebo
Participants received Wujia Yizhi granules simulator 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12).
时间窗: Change from Baseline to Month 12
The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment.
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
时间窗: Change from Baseline to Month 12
The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment.
次要结局
- Change from baseline to endpoint in ADAS-Cog12.(Change from Baseline to month 3, 6, and 9)
- Change from baseline to endpoint in CDR-SB.(Change from Baseline to month 3, 6, and 9)
- Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale.(Change from Baseline to month 3, 6, 9 and 12)
- Change from baseline to endpoint in Neuropsychiatric Inventory (NPI).(Change from Baseline to month 3, 6, 9 and 12)
- Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score(Change from Baseline to month 3, 6, 9 and 12)
- Change from baseline to endpoint in Mini-Mental State Examination (MMSE).(Change from Baseline to month 3, 6, 9 and 12)