Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease

Preventive Medicine Research Institute51 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Alzheimer Disease

Interventions

Lifestyle medicineBEHAVIORAL

Diet: A low fat (10-15%) whole foods vegan diet, high in complex carbs and low in refined carbs (fruits, vegetables, whole grains, legumes, soy, seeds \& nuts). Calories unrestricted. Multivitamin, fish oil, curcumin, vitamin C, B12, CoQ10, lion's mane, probiotic, and magnesium. 21 meals/week and supplements provided to participants and caregivers at no cost to them. Exercise: Aerobic (e.g., walking) and strength training 30 minutes/day based on a personalized prescription from an exercise physiologist or certified personal trainer and registered nurse. Stress Management: Meditation, gentle yoga-based poses, progressive relaxation, breathing exercises, and meditation (with optional glasses) 1 hour per day, supervised by a certified stress management specialist. Group Support: Participants and their spouses/caregivers participate in a support group one hour/session, 3 days/week, supervised by a licensed mental health professional in a supportive, safe environment.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (4)

University of California, San Diego

San Diego, California, United States

Preventive Medicine Research Institute

Sausalito, California, United States

McCance Center for Brain Health, Harvard Medical School/Mass General Hospital

Boston, Massachusetts, United States

Renown Health Institute of Neurosciences

Reno, Nevada, United States

Outcomes

Primary Outcomes

Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score

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.

Time frame: At baseline and also after 20 weeks, 40 weeks.

Change from Baseline in Clinical Global Impression of Change (CGIC) score

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).

Time frame: At baseline and also after 20 weeks, 40 weeks.

Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score

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).

Time frame: At baseline and also after 20 weeks, 40 weeks.

Secondary Outcomes

Changes from baseline in the microbiome

This test measures the type and relative preponderance of gut organisms at Dr. Rob Knight's lab at UCSD. To assess whether this intervention is associated with a systematic signal in the gut microbiome, he will use 16S rRNA amplicon sequencing, metagenomic sequencing, and untargeted mass spectrometry to analyze stool samples of these study participants. This will provide the relative proportion of organisms in the microbiome of these patients at each time interval.

Time frame: At baseline and also after 20 weeks, 40 weeks.

Changes from baseline in telomere length

The leukocyte telomere length assay from PBMCs will be performed in the laboratory of Dr. Elizabeth Blackburn at UCSF using the quantitative polymerase chain reaction method to measure telomere length relative to standard reference DNA, expressed as telomere to single-copy gene ratio (T/S).

Data from ClinicalTrials.gov

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