Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 试验地点
- 77
- 主要终点
- Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)
研究概览
简要总结
ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a "made-to-measure" program on the progression rate of dementia.
详细描述
ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of non pharmacological treatments on the progression rate of dementia: Three non pharmacological treatments are being studied: cognitive training therapy, reminiscence therapy and a "made-to-measure" program. Nearly 40 "Memory Clinics" are participating. 800 patients suffering Alzheimer's Disease in the mild to moderate stage of the disease will be included. For each therapy, a standard intervention protocol has been defined. The main objective is to determine whether any or several of these non pharmacological treatments can delay the severe stage of dementia during a 2-year follow-up. The secondary outcomes assess cognitive abilities, functional abilities in activities of daily living, behavioural disturbance, apathy, quality of life, depression, caregiver burden and resource utilization
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale
- •Patients over 50 years of age
- •Patients with social security affiliation
排除标准
- •Patients suffering other type of dementia
- •Institutionalized patients
- •Patients with psychiatric disorder
- •Patients with severe pathology in the terminal stages
- •Patients receiving non pharmacological therapies other than that proposed in the study
- •Enrollment in a pharmacological trial in the first 6 months
研究组 & 干预措施
1
干预措施: Standard intervention protocol (Behavioral)
2
干预措施: Standard intervention protocol + Cognitive training therapy (Behavioral)
3
干预措施: Standard intervention protocol + Reminiscence therapy (Behavioral)
4
干预措施: Standard intervention protocol + "Made-to-measure" program (Behavioral)
结局指标
主要结局
Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)
时间窗: 2 years
次要结局
- Cognitive abilities (ADAS-cog)(2 years)
- Functional abilities in activities of daily living (DAD scale)(2 years)
- Behavioural disturbance (NPI)(2 years)
- Apathy (Apathy Inventory)(2 years)
- Quality of life (Quol-AD)(2 years)
- Depression (MADRS)(2 years)