Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from baseline in the Instrumental Activities of Daily Living (IADL) score.
研究概览
简要总结
The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patient:
- •Diagnosis of Probable Alzheimer's Disease per DSM-5 criteria;
- •In the early stage of AD (MMSE from 20 to 25);
- •Age from 60 - 80 years old;
- •Had greater than 5 years of formal education.
- •For Caregiver:
- •Members (including, but not limited to partners, children, relatives, lived-in helper of the patient) that are important for care delivery and provide care-related tasks (eg personal care, eating, cooking, cleaning) and everyday decision making to the patients. They are not required to live together or spend a specific amount of time with the patients;
- •Older than 18 years of age;
- •Possess adequate Vietnamese language skills and no cognitive impairment to conduct interview and evaluation
排除标准
- •For patient:
- •Patients with concomitant diseases (heart failure, kidney failure, liver failure or thyroid diseases) that affect cognitive functions;
- •Diagnosed with significant neurologic disease other than AD (Parkinson's disease, multi-infarct dementia, schizophrenia, history of significant head trauma followed by persistent neurologic defaults, …), major depression within the past 1 year, or taking psychoactive medications (antidepressants with significant anticholinergic side effects, neuroleptics, chronic anxiolytics or sedative hypnotics, etc) within the past 1 month;
- •Having major visual, auditory, reading, or writing impairments;
- •Patients and/or caregivers who decline to participate.
- •For cargiver:
- •Having subjective complaints of cognitive impairment prevents them from understanding the instruction from the research team;
- •Having significant visual, auditory, reading, or writing impairments;
- •Caregivers who decline to participate
研究组 & 干预措施
Paper based cognitive training
Patients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication)
干预措施: Paper - based cognitive training (Other)
Control group
Patients with Alzheimer's disease in the early stage only receive standard care (medication)
结局指标
主要结局
Change from baseline in the Instrumental Activities of Daily Living (IADL) score.
时间窗: 12 weeks from baseline cognitive assessment
Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently.
Change from baseline in the Mini-Mental State Examination (MMSE)
时间窗: 12 weeks from baseline cognitive assessment
It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. The score is between 0-30. Higher score indicating better cognition.
Change from baseline in the Digits Span forward and backward
时间窗: 12 weeks from baseline cognitive assessment
The longest digits of forward and backward are 8 and 7, respectively. The total scores are twelve for each test. Higher score indicating better cognition.
Change from baseline in the Verbal fluency test
时间窗: 12 weeks from baseline cognitive assessment
Semantic memory score will be measured using the Verbal fluency test. The verbal fluency test is a short test of verbal functioning. Participants are given 1 min to produce as many animals as possible within a semantic category (category fluency). The participant's score is the number of animals. Higher score means better cognition.
Change from baseline in the Memory tests
时间窗: 12 weeks from baseline cognitive assessment
Immediate Recall, Delayed Recall, Delayed Recognition are tests that measure memory function. Higher score indicating better cognition.
Change from baseline in the Clock drawing test
时间窗: 12 weeks from baseline cognitive assessment
1-6 points, with higher scores indicating worse visuo-spatial function.
Change from baseline in the 15-Item Version of the Boston Naming Test
时间窗: 12 weeks from baseline cognitive assessment
Cognitive test of semantic memory. Object naming to confrontation, which also depends upon intact perceptual and word retrieval ability. Higher scores indicating better cognition.
Change from baseline in the Trail Making test scores
时间窗: 12 weeks from baseline cognitive assessment
Raw score, assessing attention, executive function. TMT is divided into two parts, TMT-A and TMT-B. In the TMT part A, circles with number from 1 to 25 are arranged randomly. Numerical sequence should be connected by patients as quickly as possible, cutoff value \> 180 seconds. In the TMT part B, patients must alternate between numbers and letters, cut off value \> 300 second. Cutoff scores indicate the value above suggest cognitive performance is normal.
次要结局
- Change from baseline in the Zarit Burden Interview (ZBI) score.(12 weeks from baseline cognitive assessment)
- Percentage of participants completes the full 12-week cognitive training.(12 weeks from baseline cognitive assessment)
研究者
Tống Mai Trang
Attending Physician, Neurology Department, University Medical Center, Ho Chi Minh City
University of Medicine and Pharmacy at Ho Chi Minh City