Lifestyle Intervention for Early Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Preventive Medicine Research Institute
- Enrollment
- 51
- Locations
- 4
- Primary Endpoint
- Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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.)