Alzheimer DiseaseNCT04606420
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
A study testing Lifestyle medicine in people with Alzheimer Disease, run by Preventive Medicine Research Institute at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lifestyle medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Sep 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
Boston, Massachusetts, 02115
Renown Health Institute of Neurosciences
Reno, Nevada, 89502
University of California, San Diego
San Diego, California, 92093
Preventive Medicine Research Institute
Sausalito, California, 94965
About this study
Official title: Lifestyle Intervention for Early Alzheimer's Disease
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Lifestyle medicine
- Keywords
- Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle medicineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: At baseline and also after 20 weeks, 40 weeks.
Secondary outcomes (9)
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.
Measured: 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).
Measured: At baseline and also after 20 weeks, 40 weeks.
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).
Measured: At baseline and also after 20 weeks, 40 weeks.
Inflammatory biomarkers
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
Measured: At baseline and also after 20 weeks, 40 weeks.
Amyloid peptides
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
Measured: At baseline and also after 20 weeks, 40 weeks.
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
Measured: At baseline and also after 20 weeks, 40 weeks.
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.
Measured: At baseline and also after 20 weeks, 40 weeks.
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.
Measured: At baseline and also after 20 weeks, 40 weeks.
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.
Measured: At baseline and also after 20 weeks, 40 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start8 Sep 2018
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Preventive Medicine Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Harvard Medical School (HMS and HSDM), University of California, San Diego, The Cleveland Clinic, Renown Health
- Responsible party
- Sponsor
- Investigators
- Dean Ornish, MD, Principal investigator, President, Preventive Med Res Inst; Clinical Prof Medicine UCSFCatherine Madison, MD, Study director, Chief Neurologist, Preventive Medicine Research InstituteRudolph E Tanzi, PhD, Study director, Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General HospitalSteven E. Arnold, MD, Study director, Director, Alzheimer's Clinical and Translational Research Unit, Harvard Medical School/Mass General HospitalJonathan Rosand, MD, Study director, Kistler Endowed Chair in Neurology, Harvard Medical School/Mass General HospitalDouglas Galasko, MD, Study director, Professor of Neurology, University of California, San DiegoDavid A Sinclair, PhD, Study director, Co-Director, Paul Glenn Labs for the Biology of Aging, Harvard Medical SchoolJonathan Artz, MD, Study director, Renown Health Institute of Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606420
- Sponsor's protocol ID
- 20172897
- Status last verified
- Aug 2022
- First submitted
- 8 Oct 2020
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
PubMed 9863851Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036.
PubMed 7674504Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
PubMed 1973470Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
PubMed 16094059Dunn-Emke SR, Weidner G, Pettengill EB, Marlin RO, Chi C, Ornish DM. Nutrient adequacy of a very low-fat vegan diet. J Am Diet Assoc. 2005 Sep;105(9):1442-6. doi: 10.1016/j.jada.2005.06.028.
PubMed 16129088Dewell A, Weidner G, Sumner MD, Chi CS, Ornish D. A very-low-fat vegan diet increases intake of protective dietary factors and decreases intake of pathogenic dietary factors. J Am Diet Assoc. 2008 Feb;108(2):347-56. doi: 10.1016/j.jada.2007.10.044.
PubMed 18237581Ornish D, Lin J, Daubenmier J, Weidner G, Epel E, Kemp C, Magbanua MJ, Marlin R, Yglecias L, Carroll PR, Blackburn EH. Increased telomerase activity and comprehensive lifestyle changes: a pilot study. Lancet Oncol. 2008 Nov;9(11):1048-57. doi: 10.1016/S1470-2045(08)70234-1. Epub 2008 Sep 15.
PubMed 18799354Ornish D, Magbanua MJ, Weidner G, Weinberg V, Kemp C, Green C, Mattie MD, Marlin R, Simko J, Shinohara K, Haqq CM, Carroll PR. Changes in prostate gene expression in men undergoing an intensive nutrition and lifestyle intervention. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8369-74. doi: 10.1073/pnas.0803080105. Epub 2008 Jun 16.
PubMed 18559852Chainani-Wu N, Weidner G, Purnell DM, Frenda S, Merritt-Worden T, Pischke C, Campo R, Kemp C, Kersh ES, Ornish D. Changes in emerging cardiac biomarkers after an intensive lifestyle intervention. Am J Cardiol. 2011 Aug 15;108(4):498-507. doi: 10.1016/j.amjcard.2011.03.077. Epub 2011 May 31.
PubMed 21624543Ornish D, Lin J, Chan JM, Epel E, Kemp C, Weidner G, Marlin R, Frenda SJ, Magbanua MJM, Daubenmier J, Estay I, Hills NK, Chainani-Wu N, Carroll PR, Blackburn EH. Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study. Lancet Oncol. 2013 Oct;14(11):1112-1120. doi: 10.1016/S1470-2045(13)70366-8. Epub 2013 Sep 17.
PubMed 24051140Silberman A, Banthia R, Estay IS, Kemp C, Studley J, Hareras D, Ornish D. The effectiveness and efficacy of an intensive cardiac rehabilitation program in 24 sites. Am J Health Promot. 2010 Mar-Apr;24(4):260-6. doi: 10.4278/ajhp.24.4.arb.
PubMed 20232608Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
PubMed 25771249Tangney CC, Li H, Wang Y, Barnes L, Schneider JA, Bennett DA, Morris MC. Relation of DASH- and Mediterranean-like dietary patterns to cognitive decline in older persons. Neurology. 2014 Oct 14;83(16):1410-6. doi: 10.1212/WNL.0000000000000884. Epub 2014 Sep 17.
PubMed 25230996Norton S, Matthews FE, Barnes DE, Yaffe K, Brayne C. Potential for primary prevention of Alzheimer's disease: an analysis of population-based data. Lancet Neurol. 2014 Aug;13(8):788-94. doi: 10.1016/S1474-4422(14)70136-X.
PubMed 25030513Toni N, Teng EM, Bushong EA, Aimone JB, Zhao C, Consiglio A, van Praag H, Martone ME, Ellisman MH, Gage FH. Synapse formation on neurons born in the adult hippocampus. Nat Neurosci. 2007 Jun;10(6):727-34. doi: 10.1038/nn1908. Epub 2007 May 7.
PubMed 17486101
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention for Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04606420
- Acronym / sponsor ID
- 20172897
- Conditions
- Alzheimer Disease
- Keywords
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Preventive Medicine Research InstituteUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Harvard Medical School (HMS and HSDM), University of California, San Diego, The Cleveland Clinic, Renown Health
- Study start
- 8 Sep 2018 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental (Intervention) Group | Experimental | Behavioral: Lifestyle medicineThese 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. |
| 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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle medicineDiet: 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. | Behavioural | Experimental (Intervention) Group |
Primary outcome
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.
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).
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).
9 secondary outcomes
Changes from baseline in the microbiome
Time frame: At baseline and also after 20 weeks, 40 weeks.
Changes from baseline in telomere length
Time frame: At baseline and also after 20 weeks, 40 weeks.
Changes from baseline in biomarkers
Time frame: At baseline and also after 20 weeks, 40 weeks.
Inflammatory biomarkers
Time frame: At baseline and also after 20 weeks, 40 weeks.
Amyloid peptides
Time frame: At baseline and also after 20 weeks, 40 weeks.
R-PLEX measures
Time frame: At baseline and also after 20 weeks, 40 weeks.
Angiogenesis biomarkers
Time frame: At baseline and also after 20 weeks, 40 weeks.
Vascular injury panel 2
Time frame: At baseline and also after 20 weeks, 40 weeks.
Metabolic Panel: 1 Human 7-PLEX
Time frame: At baseline and also after 20 weeks, 40 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Background: PubMed 9863851Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
- Background: PubMed 7674504Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036.
- Background: PubMed 1973470Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
- Background: PubMed 16094059Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
- Background: PubMed 16129088Dunn-Emke SR, Weidner G, Pettengill EB, Marlin RO, Chi C, Ornish DM. Nutrient adequacy of a very low-fat vegan diet. J Am Diet Assoc. 2005 Sep;105(9):1442-6. doi: 10.1016/j.jada.2005.06.028.
- Background: PubMed 18237581Dewell A, Weidner G, Sumner MD, Chi CS, Ornish D. A very-low-fat vegan diet increases intake of protective dietary factors and decreases intake of pathogenic dietary factors. J Am Diet Assoc. 2008 Feb;108(2):347-56. doi: 10.1016/j.jada.2007.10.044.
- Background: PubMed 18799354Ornish D, Lin J, Daubenmier J, Weidner G, Epel E, Kemp C, Magbanua MJ, Marlin R, Yglecias L, Carroll PR, Blackburn EH. Increased telomerase activity and comprehensive lifestyle changes: a pilot study. Lancet Oncol. 2008 Nov;9(11):1048-57. doi: 10.1016/S1470-2045(08)70234-1. Epub 2008 Sep 15.
- Background: PubMed 18559852Ornish D, Magbanua MJ, Weidner G, Weinberg V, Kemp C, Green C, Mattie MD, Marlin R, Simko J, Shinohara K, Haqq CM, Carroll PR. Changes in prostate gene expression in men undergoing an intensive nutrition and lifestyle intervention. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8369-74. doi: 10.1073/pnas.0803080105. Epub 2008 Jun 16.
- Background: PubMed 21624543Chainani-Wu N, Weidner G, Purnell DM, Frenda S, Merritt-Worden T, Pischke C, Campo R, Kemp C, Kersh ES, Ornish D. Changes in emerging cardiac biomarkers after an intensive lifestyle intervention. Am J Cardiol. 2011 Aug 15;108(4):498-507. doi: 10.1016/j.amjcard.2011.03.077. Epub 2011 May 31.
- Background: PubMed 24051140Ornish D, Lin J, Chan JM, Epel E, Kemp C, Weidner G, Marlin R, Frenda SJ, Magbanua MJM, Daubenmier J, Estay I, Hills NK, Chainani-Wu N, Carroll PR, Blackburn EH. Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study. Lancet Oncol. 2013 Oct;14(11):1112-1120. doi: 10.1016/S1470-2045(13)70366-8. Epub 2013 Sep 17.
- Background: PubMed 20232608Silberman A, Banthia R, Estay IS, Kemp C, Studley J, Hareras D, Ornish D. The effectiveness and efficacy of an intensive cardiac rehabilitation program in 24 sites. Am J Health Promot. 2010 Mar-Apr;24(4):260-6. doi: 10.4278/ajhp.24.4.arb.
- Background: PubMed 25771249Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Ornish, MD principal investigator
President, Preventive Med Res Inst; Clinical Prof Medicine UCSF
Catherine Madison, MD study director
Chief Neurologist, Preventive Medicine Research Institute
Rudolph E Tanzi, PhD study director
Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle medicine in people with Alzheimer Disease, run by Preventive Medicine Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606420, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.