Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Change in global cognition
研究概览
简要总结
Age-related cognitive decline is unavoidable. However, recent results of neuroplasticity-based research show that neuroplasticity-based training and physical activity might have the potential to decelerate or even reverse effects of aging and age-related cognitive impairments. Little is known whether these results also apply to pathological processes of aging such as mild cognitive impairment (MCI) and dementia.
This multi-center study aims at investigating efficiency and feasibility of a neuroplasticity-based auditory discrimination training and a physical fitness training for patients suffering from mild cognitive impairment or mild Alzheimer's disease (Mini Mental State Examination, MMSE > 19). Evaluation will include neuropsychological testing, electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as blood and liquor analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •focus: subjective and/or objective memory complaints with MMSE > 19 (MCI or mild Alzheimer's Disease, with stable medication for at least 3 months)
- •mild to moderate depression
- •corrected-to-normal hearing and vision
- •for MRI: non-magnetic metals inside the body
- •right handedness preferred
排除标准
- •cognitive impairment/ dementia with MMSE < 20, severe psychiatric or neurological disease (current and lifetime)
- •physical health that does not allow physical fitness tests and trainings
- •benzodiazepin, tricyclic antidepressants
- •for MRI: magnetic metal inside the body, cardiac pacemaker etc.
- •for liquor: insufficient blood coagulation, insufficient brain pressure
结局指标
主要结局
Change in global cognition
时间窗: pre, post, 3-month follow-up
Average score of the two component scores "memory" and "attention / executive functions", derived from principal component analysis of 11 cognitive items (Munich verbal memory test (MVGT) encoding, MVGT long delayed free recall, free recall of the Alzheimer's Disease Assessment Scale, working memory in the Everyday Cognition Battery, Trail Making Test A and B, digit span forward and backward, digit-symbol-coding and semantic and phonematic fluency).
次要结局
- electrophysiological, MRI, blood and liquor correlates(pre, post, 3-month follow-up)
研究者
Iris-Tatjana Kolassa
Prof. Dr. Iris-Tatjana Kolassa
University of Ulm