Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
研究概览
简要总结
The purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and Tai Chi- Qi Gong training in participants with Early-Onset Alzheimer's Disease. It is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.
详细描述
This study aims to generate preliminary data regarding the efficacy of a combined cognitive-training and Tai Chi- Qi Gong exercise lifestyle intervention in participants diagnosed with Early-Onset Alzheimer's Disease (EOAD). Participants will complete a series of cognitive, functional, and mood assessments at a remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control. Outcome measures will be repeated immediately Post-Treatment and at 6-months post-treatment Follow-Up. Specific Aim 1 will examine the feasibility of this lifestyle intervention and outcome assessments when applied to participants with EOAD. Specific Aim 2 will investigate if this lifestyle intervention improves short- and long-term cognition, functioning, and mood. Specific Aim 3 will be exploratory to assess whether individual differences in training or clinical/ demographic characteristics moderate the degree of benefit from this intervention; owing to sample size limitations in this feasibility study, focus of this latter aim will be on determining effect sizes and sample-size magnitude needed for future work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and outcomes assessor (study coordinator) will be masked to intervention assignment. Principle investigator will not be masked given the size of the study team.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the Longitudinal Early-Onset AD Study (LEADS) parent study, and being classified via LEADS consensus criteria as having amyloid-positive Early Onset Alzheimer's Disease
- •Aged 40-64 years at the time of enrollment into LEADS
- •Fluent in English
- •In good general health and absent another neurological disorder
- •Have a knowledgeable informant.
- •Have had a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment into LEADS
- •Have sufficient vision, hearing, comprehension, and manual dexterity to participate in the testing and training program
排除标准
- •Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week
研究组 & 干预措施
Experimental Cognitive Training and Tai Chi- Qi Gong Arm
Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training
干预措施: Cognitive Training (Device)
Experimental Cognitive Training and Tai Chi- Qi Gong Arm
Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training
干预措施: Tai Chi- Qi Gong (Behavioral)
Active Control Arm
Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching
干预措施: Brain Games (Device)
Active Control Arm
Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching
干预措施: Stretching (Behavioral)
结局指标
主要结局
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
时间窗: 15-Week Post-Intervention Follow-up
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance
时间窗: 15-Week Post-Intervention Follow-up
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance
时间窗: 40-Week Post-Intervention Follow-up
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance
时间窗: 40-Week Post-Intervention Follow-up
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
次要结局
- Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance(15-Week Post-Intervention Follow-up)
- Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance(40-Week Post-Intervention Follow-up)
- Performance on scales of functioning immediately post-intervention, after controlling for baseline performance(15-Week Post-Intervention Follow-up)
- Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance(40-Week Post-Intervention Follow-up)
- Self-reported depression immediately post-intervention, after controlling for baseline performance(15-Week Post-Intervention Follow-up)
- Self-reported depression 26 weeks after intervention, after controlling for baseline performance(40-Week Post-Intervention Follow-up)
- Self-reported quality of life immediately post-intervention, after controlling for baseline performance(15-Week Post-Intervention Follow-up)
- Self-reported quality of life 26 weeks after intervention, after controlling for baseline performance(40-Week Post-Intervention Follow-up)
- Self-reported stress immediately post-intervention, after controlling for baseline performance(15-Week Post-Intervention Follow-up)
- Self-reported stress 26 weeks after intervention, after controlling for baseline performance(40-Week Post-Intervention Follow-up)
- Self-reported perceived social support immediately post-intervention, after controlling for baseline performance(15-Week Post-Intervention Follow-up)
- Self-reported perceived social support 26 weeks after intervention, after controlling for baseline performance(40-Week Post-Intervention Follow-up)
研究者
Dustin Hammers
Associate Professor
Indiana University