Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease

NCT04606420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-09-15

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

BEHAVIORAL

Lifestyle medicine

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.

Sponsors & Collaborators

Principal Investigators

  • Dean Ornish, MD · President, Preventive Med Res Inst; Clinical Prof Medicine UCSF

  • Catherine Madison, MD · Chief Neurologist, Preventive Medicine Research Institute

  • Rudolph E Tanzi, PhD · Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General Hospital

  • Steven E. Arnold, MD · Director, Alzheimer's Clinical and Translational Research Unit, Harvard Medical School/Mass General Hospital

  • Jonathan Rosand, MD · Kistler Endowed Chair in Neurology, Harvard Medical School/Mass General Hospital

  • Douglas Galasko, MD · Professor of Neurology, University of California, San Diego

  • David A Sinclair, PhD · Co-Director, Paul Glenn Labs for the Biology of Aging, Harvard Medical School

  • Jonathan Artz, MD · Renown Health Institute of Neurosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-08
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04606420 on ClinicalTrials.gov