Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- Change in AD specific component score
研究概览
简要总结
Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time.
The main objective of this study is to test, if the computerized-cognitive training (CCT) is able to improve the performance in a score quantifying an "AD-specific" component score. Additionally, the neurobiological effects of the training are investigated.
详细描述
The study intervention consists of a computer-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months the intervention group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.
Primary endpoint will be the change in an "AD-specific" component score, quantified by episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes in task related brain networks and changes in resting state networks.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Alzheimer's Disease
- •Patients with increased risk for developing dementia
- •Must be able to give their consent
排除标准
- •Contra-indications for MRI scanning
- •Substance abuse
- •Severe medical conditions
结局指标
主要结局
Change in AD specific component score
时间窗: The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.
The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure.
次要结局
- MRI functional and structural(Secondary endpoints will be assessed two to four times, depending on the study arm, as MRI assessments are not always performed after six and nine months.)