Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease

• ClinicalTrials.gov Identifier: NCT04606420
• Recruitment Status: Active, not recruiting
• First Posted: October 28, 2020
• Last Update Posted: September 15, 2022
• Sponsor: Preventive Medicine Research Institute
• Collaborators: University of California, San Francisco; Harvard Medical School (HMS and HSDM); University of California, San Diego; The Cleveland Clinic; Renown Health
• Information provided by (Responsible Party): Preventive Medicine Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease	Behavioral: Lifestyle medicine	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment

Intervention Model Description

In this randomized crossover design, 51 patients with early Alzheimer's disease were randomly-assigned to one of two groups. After baseline testing, the first group receives the lifestyle program for 20 weeks (via Zoom since 2/20 due to COVID-19). The second group does not and is a randomized control group during this phase. Both groups are re-tested after 20 weeks. Then, the second group "crosses over" and receives this program for 20 weeks and the first group continues the program for 20 additional weeks. After 40 weeks, both groups are re-tested again. Patients initially randomly assigned to the control group will receive the intervention for a total of 40 weeks and then be re-tested.

Due to challenges in recruiting patients, including Covid-19, we recently terminated recruitment after 51 patients were recruited. This decision was based on recruitment and funding issues, without review of any of the data. This trial will continue until all 51 patients have completed it.

• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Lifestyle Intervention for Early Alzheimer's Disease
• Actual Study Start Date: September 8, 2018
• Estimated Primary Completion Date: September 30, 2023
• Estimated Study Completion Date: September 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental (Intervention) Group; These patients will receive the comprehensive lifestyle medicine intervention from day 1 through the end of the study. They will be tested at baseline, after 20 weeks, and after 40 weeks.	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.
No Intervention: Control (Non-Intervention) Group; These patients will be asked to continue their current diet and lifestyle without making any changes for 20 weeks. They will be tested at baseline and after 20 weeks. Then, they will "cross over" and receive the same lifestyle medicine intervention for 20 weeks and will be tested again after 20 weeks of the intervention and also after 40 weeks of the intervention. After 20 weeks in the randomized control group, patients who no longer meet these eligibility criteria (e.g, a MoCA score <18) will not cross over and will not receive the lifestyle intervention; their data during the first 20 weeks in the control group (when they met the entry criteria) will be used.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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).
3. 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).

Secondary Outcome Measures :

1. Changes from baseline in the microbiome [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   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.
2. Changes from baseline in telomere length [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   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).
3. Changes from baseline in biomarkers [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   These are measures of inflammation (C-reactive protein in mg/L), genomics, serum amyloid (C2N), angiogenesis, lipids (total cholesterol, LDL-cholesterol, triglycerides in mg/dl), blood pressure (mm Hg), and weight (pounds).
4. Inflammatory biomarkers [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   Inflammatory Human ProInflammatory 10-Plex: IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 p70, IL-13, TNF-α. Tanzi Lab, Harvard Medical School/Mass General Hospital McCance Center for Brain Health & MassGeneral Institute for Neurodegenerative Disease
5. Amyloid peptides [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   Human Aβ Peptide Panel 1 (6E10) 3-plex: Aβ38, Aβ40, and Aβ42 The Phospho(Thr231)/Total Tau Kit; p-tau 181; p-tau217. Tanzi Lab, Harvard Medical School/Mass General Hospital McCance Center for Brain Health & MassGeneral Institute for Neurodegenerative Disease
6. R-PLEX measures [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   Neurofilament light chain (NF-L): custom-make; R-PLEX Human Neurofilament L Antibody Set; GFAP: custom-make; R-PLEX Human GFAP Antibody Set S100 family proteins: custom-make; R-PLEX Human S100A8/MRP8 Antibody Set. Tanzi Lab, Harvard Medical School/Mass General Hospital McCance Center for Brain Health & MassGeneral Institute for Neurodegenerative Disease
7. Angiogenesis biomarkers [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   Angiogenesis Panel 1 (human) measures 7-plex proteins: VEGF-A, VEGF-C, VEGF-D, Tie-2, Flt-1, PlGF, and FGF (basic). Arnold Lab, Harvard Medical School/Massachusetts General Hospital Alzheimer's Clinical and Translational Research Unit and Interdisciplinary Brain Center.
8. Vascular injury panel 2 [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   Measure 4-plex protein: SAA, CRP, VCAM-1, and ICAM-1. Arnold Lab, Harvard Medical School/Massachusetts General Hospital Alzheimer's Clinical and Translational Research Unit and Interdisciplinary Brain Center.
9. Metabolic Panel: 1 Human 7-PLEX [ Time Frame: At baseline and also after 20 weeks, 40 weeks. ]
   C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, Leptin, PP Quanterix Banyan Panel: p-TAU, NFL, GFAP, UCHL1. Arnold Lab, Harvard Medical School/Massachusetts General Hospital Alzheimer's Clinical and Translational Research Unit and Interdisciplinary Brain Center.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

University of California, San Diego

San Diego, California, United States, 92093

Preventive Medicine Research Institute

Sausalito, California, United States, 94965

United States, Massachusetts

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

Boston, Massachusetts, United States, 02115

United States, Nevada

Renown Health Institute of Neurosciences

Reno, Nevada, United States, 89502

Sponsors and Collaborators

Preventive Medicine Research Institute

University of California, San Francisco

Harvard Medical School (HMS and HSDM)

University of California, San Diego

The Cleveland Clinic

Renown Health

Investigators

• Principal Investigator: Dean Ornish, MD; President, Preventive Med Res Inst; Clinical Prof Medicine UCSF
• Study Director: Catherine Madison, MD; Chief Neurologist, Preventive Medicine Research Institute
• Study Director: Rudolph E Tanzi, PhD; Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
• Study Director: Steven E. Arnold, MD; Director, Alzheimer's Clinical and Translational Research Unit, Harvard Medical School/Mass General Hospital
• Study Director: Jonathan Rosand, MD; Kistler Endowed Chair in Neurology, Harvard Medical School/Mass General Hospital
• Study Director: Douglas Galasko, MD; Professor of Neurology, University of California, San Diego
• Study Director: David A Sinclair, PhD; Co-Director, Paul Glenn Labs for the Biology of Aging, Harvard Medical School
• Study Director: Jonathan Artz, MD; Renown Health Institute of Neurosciences

More Information

Publications:

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• Responsible Party: Preventive Medicine Research Institute
• ClinicalTrials.gov Identifier: NCT04606420
• Other Study ID Numbers: 20172897
• First Posted: October 28, 2020
• Last Update Posted: September 15, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Preventive Medicine Research Institute:

Mild Cognitive Impairment

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders