Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease

NCT04606420 | Unknown

• 1 other identifier: 20172897
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

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.

Conditions

Alzheimer Disease

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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).

  At baseline and also after 20 weeks, 40 weeks.

Secondary Outcomes (9)

• 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.

• 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.

• Amyloid peptides

  At baseline and also after 20 weeks, 40 weeks.

Study Arms (2)

Experimental (Intervention) Group

EXPERIMENTAL

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

Control (Non-Intervention) Group

NO INTERVENTION

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.

Interventions

Lifestyle medicine BEHAVIORAL

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.

Experimental (Intervention) Group

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Preventive Medicine Research Institute: lead
• University of California, San Francisco: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of California, San Diego: collaborator
• The Cleveland Clinic: collaborator
• Renown Health: collaborator

Study Sites (4)

University of California, San Diego

San Diego, California, 92093, United States

Location

Preventive Medicine Research Institute

Sausalito, California, 94965, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Renown Health Institute of Neurosciences

Reno, Nevada, 89502, United States

Location

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MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Dean Ornish, MD

  President, Preventive Med Res Inst; Clinical Prof Medicine UCSF

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 28, 2020
• Study Start: September 8, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 15, 2022

Record last verified: 2022-08

Locations

US (4)