Open Label Clinical Trial to Study the Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change from baseline in processing speed
研究概览
简要总结
This study is designed to evaluate the preliminary effectiveness and safety of a digitally based multidomain intervention in patients with MCI. In addition, a portion of cognitively normal subjects and caregivers of patients with MCI will also be recruited as an exploratory cohort. We hope that the digital platform will improve the overall cognition and quality of life in patients with MCI.
详细描述
3 groups of participants will be recruited. For the participants in the MCI (group A) and cognitively normal subjects (group B), they will be provided with a digital tablet and a wearable device. The digital tablet will be pre-loaded with 10 modules, 1 module per week (1 hour) for 10 weeks to be completed at home. The wearable device will be used to track and collect physiological data.
For the caregivers of the patients with MCI (group C), they will be asked to complete a questionnaire during screening visit and follow-up visit, and to use the caregiver app during the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with MCI Thirty (30) patients with MCI of the amnestic type (single or multi domain) will be recruited. MCI will be diagnosed using the Petersen's criteria and/or the NIA-AA criteria by cognitive neurologists.
- •Inclusion criteria:
- •Either male or female aged between 50 and 70 years (inclusive)
- •Diagnosis of amnestic MCI using the Petersen's criteria and/or the NIA-AA criteria
- •Clinical Dementia Rating (CDR) score of 0.5 and Mini-Mental State Examination (MMSE) >24
- •Education >6 years
- •Literate in English
- •Basic proficiency in using web-based applications/mobile platforms
- •Willing to give informed consent
排除标准
- •Significant hearing or visual impairment
- •Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
- •Participation in any pharmacological or non-pharmacological (interventional) clinical trial in the preceding 12 weeks
- •Cognitively Normal Subjects Ten (10) cognitively normal subjects will be recruited.
- •Inclusion criteria:
- •Either male or female aged between 50 and 70 years (inclusive)
- •CDR of 0 and MMSE > 27
- •Education >6 years
- •Literate in English
- •Basic proficiency in using web-based applications/mobile platforms
- •Willing to give informed consent
- •Exclusion criteria:
- •Significant hearing or visual impairment
- •Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
- •Participation in any pharmacological or non-pharmacological clinical trial in the preceding 12 weeks
- •Caregivers of Patients with MCI Fifteen (15) caregivers of the 30 patients with MCI will be recruited.
- •Inclusion criteria:
- •Either male or female aged ≥21 years
- •Is the spouse or child of the patient and must spend at least 2 hours per week with the patient.
- •Must be healthy and not suffering from any serious systemic, neurological or psychiatric illness.
- •Literate in English
- •Willing to give informed consent Exclusion criteria: NA
结局指标
主要结局
Change from baseline in processing speed
时间窗: Baseline compared to Week 11
Using Neuropsychological Test Battery (NTB) Processing Speed domain items (symbol digit modalities test, trail making test A, and Stroop test (condition 1 and 2) in patients with MCI
Change from baseline in executive functioning
时间窗: Baseline compared to Week 11
Using the NTB Executive Function domain items (digit span test, verbal fluency test, similarities test from Wechsler Adult Intelligence Scale IV (WAIS-IV) and trail making test B) in patients with MCI
Change from baseline in mood using the Depression Anxiety Stress Scales (DASS-21) in patients with MCI
时间窗: Baseline compared to Week 11
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The scoring ranges from 0 to 3 per item. The higher the score, the greater the sense of depression, anxiety or stress.
次要结局
- Change from baseline in overall cognition in patients with MCI(Baseline compared to Week 11)
- Change from baseline in QoL(Baseline compared to Week 11)