Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Lifestyle Intervention for Early Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04606420
• Other study ID #: 20172897
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Preventive Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
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	University of California, San Diego	San Diego	California
United States	Preventive Medicine Research Institute	Sausalito	California

Sponsors (6)

Lead Sponsor	Collaborator
Preventive Medicine Research Institute	Harvard Medical School (HMS and HSDM), Renown Health, The Cleveland Clinic, University of California, San Diego, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.	At baseline and also after 20 weeks, 40 weeks.
Secondary	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).	At baseline and also after 20 weeks, 40 weeks.
Secondary	Changes from baseline in biomarkers	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).	At baseline and also after 20 weeks, 40 weeks.
Secondary	Inflammatory biomarkers	Inflammatory Human ProInflammatory 10-Plex: IFN-?, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 p70, IL-13, TNF-a. Tanzi Lab, Harvard Medical School/Mass General Hospital McCance Center for Brain Health & MassGeneral Institute for Neurodegenerative Disease	At baseline and also after 20 weeks, 40 weeks.
Secondary	Amyloid peptides	Human Aß Peptide Panel 1 (6E10) 3-plex: Aß38, Aß40, and Aß42 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	At baseline and also after 20 weeks, 40 weeks.
Secondary	R-PLEX measures	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	At baseline and also after 20 weeks, 40 weeks.
Secondary	Angiogenesis biomarkers	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.	At baseline and also after 20 weeks, 40 weeks.
Secondary	Vascular injury panel 2	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.	At baseline and also after 20 weeks, 40 weeks.
Secondary	Metabolic Panel: 1 Human 7-PLEX	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.	At baseline and also after 20 weeks, 40 weeks.