Lifestyle Intervention for Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
研究概览
简要总结
The objective of this study is to determine if comprehensive lifestyle changes may slow, stop, or reverse the progression of early-stage Alzheimer's disease.
详细描述
51 patients who have early Alzheimer's disease (MoCA above 17) in the San Francisco Bay area were enrolled over time and are randomly assigned to one of two groups.
After baseline testing, the first group then receives this lifestyle medicine program for 20 weeks, four hours/day, three days/week (all done virtually via Zoom since March 2020 due to COVID-19).
The second group will not receive the lifestyle program for 20 weeks and will serve as a randomized control group during this phase of the study.
Both groups will be re-tested after 20 weeks.
Then, the second group will "cross over" and receive this lifestyle medicine program for 20 weeks and the first group will continue the lifestyle program for 20 additional weeks. After a total of 40 weeks, both groups will be re-tested again and compared. Those initially randomly assigned to the control group will receive the intervention for 40 weeks and then be re-tested at that time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Since this is a behavioral intervention, it is not possible to blind the participant and the care provider from whether or not they are receiving the intervention. However, everyone involved in testing patients (Outcome Assessors) is blinded to group assignment.
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of mild dementia or mild cognitive impairment due to Alzheimer's disease/process (McKhann and Albert criteria), with MoCA score above 17 (i.e., 18 or higher)
- •Willingness and ability to participate in all aspects of the intervention
- •Availability of spouse or caregiver who can provide collateral information and assist with study adherence
排除标准
- •severe dementia
- •physical disability that precludes regular exercise
- •clear evidence for other causes of neurodegeneration or dementia, e.g., severe cerebrovascular disease, Parkinson's disease
- •significant ongoing psychiatric or substance abuse problems
结局指标
主要结局
Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
时间窗: At baseline and also after 20 weeks, 40 weeks.
The ADAS-Cog test is one of the most frequently used tests to measure cognition in clinical trials. Patients obtain scores of 0 to 70; higher scores indicate poorer performance.
Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score
时间窗: At baseline and also after 20 weeks, 40 weeks.
The CDR-SOB is a commonly used dementia staging instrument. The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18 (lower is better).
Change from Baseline in Clinical Global Impression of Change (CGIC) score
时间窗: At baseline and also after 20 weeks, 40 weeks.
The CGIC test is often used in clinical trials of cognition. CGIC scores range from 1 (very much improved) through to 7 (very much worse).
次要结局
- Vascular injury panel 2(At baseline and also after 20 weeks, 40 weeks.)
- Changes from baseline in the microbiome(At baseline and also after 20 weeks, 40 weeks.)
- Changes from baseline in telomere length(At baseline and also after 20 weeks, 40 weeks.)
- Amyloid peptides(At baseline and also after 20 weeks, 40 weeks.)
- Metabolic Panel: 1 Human 7-PLEX(At baseline and also after 20 weeks, 40 weeks.)
- Changes from baseline in biomarkers(At baseline and also after 20 weeks, 40 weeks.)
- Inflammatory biomarkers(At baseline and also after 20 weeks, 40 weeks.)
- R-PLEX measures(At baseline and also after 20 weeks, 40 weeks.)
- Angiogenesis biomarkers(At baseline and also after 20 weeks, 40 weeks.)