Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change score of the Chinese version Verbal Learning Test (CVVLT).
研究概览
简要总结
The specific study aims:
- To investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC.
- To examine whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
- To investigate the lasting duration of the intervention.
详细描述
Although there is much evidence showing age-related reduction of cognitive function, many researchers point out a more optimistic viewpoint that aging is not a progressive loss. By remodeling the lifestyle, or/and monitoring the physical factors, the risk to develop dementia could be reduced. The above statements are mostly based on the epidemiological research, while it remains unclear how the aging modulates the brain changes. In previous study, the investigators have found that individuals with subjective memory complaint (SMC) showed altered brain changes in terms of resting-state connectivity when compared to those without SMC. The present study further aims to examine whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC. More importantly, this study aims to clarify whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
In summary, the present study aims to understand how the lifestyle remodeling affects SMC's brain function and biochemical indicators. Before and after the intervention, this study will use neuropsychological tests to assess all the aspects of cognitive functions, use Electroencephalogram to investigate the brain activation patterns, and use biochemical analyses to quantify the reactivity of inflammation, toxic as well as neurotrophic factors. Through the follow-up design, this study also plan to investigate the lasting duration of the intervention and the how the neural reorganization occurs as function of time.
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
- •Age over 50 years old.
- •Diagnosed with subjective memory complaint (SMC) and with lower cognitive activities and physical activities.
- •Voluntary to sign the Informed Consent Form.
排除标准
- •Participants or first-degree relatives diagnosed with mental diseases.
- •Participants have history of severe neurological diseases or brain injury led to loss of consciousness.
- •Participants have diagnosis of cardiovascular disease.
- •Participants have History of alcohol, Nicotine, or substance dependence.
- •Participants suffer from visual, hearing degradation (including Hearing aid user).
结局指标
主要结局
Change score of the Chinese version Verbal Learning Test (CVVLT).
时间窗: baseline, post-treatment (6 months), follow-up (12 months)
A nine-item of CVVLT (total recall, delayed recall) will be applied to measure the participant's memory ability, with a higher score indicating better performance.
Change score of the WMS-III logical memory test part A.
时间窗: baseline, post-treatment (6 months), follow-up (12 months)
WMS-III logical memory test part A (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 25 for each recall trial, with a higher score indicating better performance.
Concentration change from baseline in the blood biochemical indices. (Total Tau, Aβ1-40, Aβ1-42, IL-1b, TNF-a, IL-6, TGF-b, BDNF, insulin, and ApoE4)
时间窗: baseline, post-treatment (6 months), follow-up (12 months)
Blood samples will use an enzyme-linked immunosorbent assay (ELISA) to assay the concentrations of Tau, Beta Amyloid (Aβ)1-40, Aβ1-42, interleukin-1β (IL-1β), tumor necrosis factor (TNF)-⍺, Interleukin-6 (IL-6), transforming growth factor (TGF)-β, brain-derived neurotrophic factor (BDNF), insulin, etc. The apolipoprotein E4 (ApoE4) genotype will also be evaluated.
Change score of the Taylor Complex Figure Test (TCFT).
时间窗: baseline, post-treatment (6 months), follow-up (12 months)
TCFT (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 36 for each recall trial, with a higher score indicating better performance.
Changes in Electroencephalogram (EEG) performance.
时间窗: baseline, post-treatment (6 months), follow-up (12 months)
The amplitude, latency of MMN (mismatch negativity), N2, and the P3 components will be used to evaluate the memory and inhibitory control ability. Other EEG time-frequency analysis will be used to examine the changes of different frequency bands, such as theta, alpha, beta, and gamma.
Change score of the Digit Span Backward Test.
时间窗: baseline, post-treatment (6 months), follow-up (12 months)
The Digit Span Backwards Task will be applied to measure the participant's working memory ability. A higher score indicating better performance.
次要结局
- Physiological parameter (Blood pressure and blood glucose) survey.(baseline, post-treatment (6 months), follow-up (12 months))
- Change score of the Boston Naming Test (BNT).(baseline, post-treatment (6 months), follow-up (12 months))
- Subjective memory complaint survey.(baseline, post-treatment (6 months), follow-up (12 months))
- Change scores of EuroQol-5 Dimension (EQ-5D).(baseline, post-treatment (6 months), follow-up (12 months))
- Performance changes of the Trail Making Test Form A/B (TMT-A/B).(baseline, post-treatment (6 months), follow-up (12 months))
- Lifestyle activities survey.(baseline, post-treatment (6 months), follow-up (12 months))
- Change score of the Cognitive Abilities Screening Instrument (CASI).(baseline, post-treatment (6 months), follow-up (12 months))
- Change score of the category Verbal Fluency Test (VFT).(baseline, post-treatment (6 months), follow-up (12 months))