A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mini-Mental State Examination (MMSE)
研究概览
简要总结
In China, herbal therapy as a complementary therapy is very popular. Should conventional therapy (such as donepezil and memantine) combined with herbal therapy make add-on benefit? Cognition, activities of daily living and behavioral symptoms will be assessed. Data will be collected from the medical records of patients with Alzheimer's disease (AD) in memory clinics.
详细描述
Conventional therapy (CT), such as donepezil and memantine are well- known short-term treatments for the symptoms of Alzheimer's disease (AD). The efficacy of them, however, drops below baseline level after 9 months. Should Chinese herbal medicine make add-on benefit? The GRAPE formula was designed by Prof. J Tian, a prepared granules of Chinese herbs, according to Qifuyin in Jing Yue Quan Shu (published in A.D. 1624). Patients treated with CT+herbal therapy or CT alone for up to and over 12 months are collected. Cognition, activities of daily living and behavioral symptoms are selected as outcomes for assessing the effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Gradual and progressive change in cognitive functions for a period greater than 6 months;
- •Objective evidence of significantly impaired episodic memory together with at least one of other cognitive domains on testing;
- •Global cognitive decline measured by mini-mental state examination (MMSE) adjusted for education: ≤22 for illiteracy, ≤23 for primary school, ≤24 for middle school,≤26 for high education;
- •Impaired abilities of daily living, ADLs score ≥16;
- •Clinical Dementia Rating (CDR) total score 0.5~3.0;
- •≤4 point on Hachinski Ischaemic Score (HIS);
- •Age-adjusted medial temporal lobe atrophy scale (MTA-scale) based on coronary magnetic resonance imaging (MRI) scan of the brain (1.0 or more for ≤65 years; 1.5 or more for ≤75 years and 2.0 or more for ≥75 years);
- •Other causes of dementia excluded.
排除标准
- •Sudden onset of cognitive disorder with focal nervous system signs in the early stages of disease, (e.g., incomplete paralysis, anesthesia, dysfunctional visual field, and dystaxia);
- •Early occurrence of the following symptoms: gait disturbances, seizures, extrapyramidal signs, hallucinations and cognitive fluctuations;
- •Any major psychiatric disorders (e.g., DSM-IV(Diagnostic and Statistical Manual of Mental Disorders) defined psychosis, major depression, bipolar disorder, or alcohol or substance abuse);
- •Other conditions that may explain cognitive impairment (e.g., hypothyroidism, electrolyte imbalance, toxic, inflammatory, and metabolic disorders).
结局指标
主要结局
Mini-Mental State Examination (MMSE)
时间窗: Up to 12 months, repeated measurement every 3 months.
Change of global cognition was measured by MMSE, a 30-point scale, higher score indicates better cognition.
次要结局
- Neuropsychiatric Inventory (NPI)(Up to 12 months, repeated measurement every 3 months.)
- Clinical Dementia Rating (CDR)(Up to 12 months, repeated measurement every 3 months.)
- Activities of Daily Living (ADLs)(Up to 12 months, repeated measurement every 3 months.)
研究者
Jinzhou Tian
Prof.
Dongzhimen Hospital, Beijing