Cognitive Rehabilitation in Alzheimer's Disease (AD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change from baseline in activities of daily living measured by a test for action regulation and planning skills (HOTAP) to the end of intervention and to follow-up (6 months later)
研究概览
简要总结
This study aims to proof the efficacy of a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease with respect to activities of daily living.
详细描述
This prospective randomized, single blind intervention study aims to proof a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease (AD). The investigators modified a manualized and established German behavioural therapy program (KORDIAL) to use in a group context. The respective modules contain multimodal and multiprofessional approaches to improve capabilities relevant to activities of daily living (external memory support, compensation strategies, training of everyday competence, communication training). The intervention group receives this therapy for 12 weeks. Age and gender matched participants with AD serve as active control sample receiving a standardized cognitive training in the domesticity. The primary outcome are measurements of skills in activities of daily living prior the intervention as well as at the end of the intervention (after 3 months) and after 6 months (Follow up).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild dementia in Alzheimer's disease (NINCDS-ADRDA)
- •Mini Mental State ≥ 17
排除标准
- •severe psychiatric disorder
- •severe brain disorder (epilepsy, tumor, stroke)
- •contraindication for MRI examination
结局指标
主要结局
Change from baseline in activities of daily living measured by a test for action regulation and planning skills (HOTAP) to the end of intervention and to follow-up (6 months later)
时间窗: prior intervention, after intervention (3 months), after 6 months
Change from baseline in activities of daily living measured by an ADL-scale (Bayer-ADL) to the end of intervention and to follow-up (6 months later)
时间窗: prior intervention, after intervention (3 months), after 6 months
Change from baseline in behavioural memory abilities measured by a behavioural memory test (RBMT) to the end of intervention and to follow-up (6 months later)
时间窗: prior intervention, after intervention (3 months), after 6 months
次要结局
- Change from baseline in general cognitive state measured by the Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) to the end of intervention and to follow-up (6 months later)(prior intervention, after intervention (3 months), after 6 months)
- Change from baseline in structural and functional connectivity of the brain measured by MRI to the end of intervention and to follow-up (6 months later)(prior intervention, after intervention (3 months), after 6 months)
- Change from baseline in depression and quality of life measured by two scales (GDS, DEMQoL) to the end of intervention and to follow-up (6 months later)(prior intervention, after intervention (3 months), after 6 months)
研究者
Elisabeth Kasper
Dipl. psych
University of Rostock