Evidence map›Paper›PMID 38849944›Full record

Trial reportAlzheimer's research & therapy2024

Effects of intensive lifestyle changes on the progression of mild cognitive impairment or early dementia due to Alzheimer's disease: a randomized, controlled clinical trial.

Dean Ornish, Catherine Madison, Miia Kivipelto, Colleen Kemp, Charles E McCulloch, Douglas Galasko, Jon Artz, Dorene Rentz, Jue Lin, Kim Norman and 12 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 87 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04606420 naunknown statusnot on this map

Lifestyle Intervention for Early Alzheimer's Disease

TypeinterventionalSponsorPreventive Medicine Research InstituteRan2018 to 2023Enrolled51ConditionsAlzheimer DiseaseArmsLifestyle medicine
NCT07146412 narecruitingnot on this mapstarted 2025, after this paper: background citation

Impact of a Multimodal Lifestyle Intervention on Dementia Risk Factors and Attitude Related to Dementia Risk: A Logistical Pilot Study

TypeinterventionalSponsorHudsonAlpha Institute for BiotechnologyRan2025 to 2026Enrolled200ConditionsCognitive Impairment, Alzheimer Blood Biomarkers, Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)ArmsMultimodal Lifestyle Intervention
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  4. Tracking electrophysiological signatures of Alzheimer's disease: a systematic review of multimodal studies.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
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27 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Dean OrnishPreventive Medicine Research Institute, 900 Bridgeway, Sausalito, CA, USA. dean.ornish@pmri.org.
Catherine MadisonPreventive Medicine Research Institute, 900 Bridgeway, Sausalito, CA, USA.
Miia KivipeltoDivision of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Karolinska vägen 37 A, SE-171 64, Solna, Sweden.
Colleen KempClinical Services, Preventive Medicine Research Institute, Bridgeway, Sausalito, CA, 900, USA.
Charles E McCullochDivision of Biostatistics, Department of Epidemiology & Biostatistics, UCSF, San Francisco, CA, USA.
Douglas GalaskoNeurosciences, University of California, San Diego, CA, USA.
Jon ArtzClinical Neurology, School of Medicine, University of Nevada, Reno, USA.
Dorene RentzHarvard Medical School, Boston, MA, USA.
Jue LinElizabeth Blackburn Lab, UCSF, San Francisco, CA, USA.
Kim NormanUCSF, San Francisco, CA, USA.
Anne OrnishPreventive Medicine Research Institute, 900 Bridgeway, Sausalito, CA, USA.
Sarah TranterClinical Services, Preventive Medicine Research Institute, Bridgeway, Sausalito, CA, 900, USA.
Nancy DeLamarterPreventive Medicine Research Institute, 900 Bridgeway, Sausalito, CA, USA.
Noel WingersPreventive Medicine Research Institute, 900 Bridgeway, Sausalito, CA, USA.
Carra RichlingPreventive Medicine Research Institute, 900 Bridgeway, Sausalito, CA, USA.
Rima Kaddurah-DaoukDepartments of Medicine and Psychiatry, Duke University Medical Center and Member, Duke Institute of Brain Sciences, Durham, NC, USA.
Rob KnightDepartment of Pediatrics; Department of Computer Science & Engineering; Department of Bioengineering; Center for Microbiome Innovation, Halıcıoğlu Data Science Institute, University of California, San Diego, La Jolla, CA, USA.
Daniel McDonaldDepartment of Pediatrics and Scientific Director, American Gut Project and The Microsetta Initiative, University of California San Diego, La Jolla, CA, USA.
Lucas PatelBioinformatics and Systems Biology Program; Rob Knight Lab; Medical Scientist Training Program, University of California, San Diego, La Jolla, CA, USA.
Eric VerdinBuck Institute for Research on Aging, San Francisco, CA, USA.
Rudolph E TanziHarvard Medical School, Boston, MA, USA.
Steven E ArnoldHarvard Medical School, Boston, MA, USA.

Funding

National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD)U24AG021886 · NIA · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI TATIANA M. FOROUD · 2002 to 2026
$119.8M
UCSD Shiley-Marcos Alzheimer's Disease Research Center P30P30AG062429 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DOUGLAS R GALASKO · 2019 to 2026
$34.9M
Alzheimer Gut Microbiome Project funded by NIA U19AG063744 & U01AG061359 & R01AG081322NIA NIH HHS P30 AG062429NIA NIH HHS U24 AG021886The Alzheimer's Drug Discovery Foundation GC-202102-2021459
6 · The paper itself

Abstract

backgroundEvidence links lifestyle factors with Alzheimer's disease (AD). We report the first randomized, controlled clinical trial to determine if intensive lifestyle changes may beneficially affect the progression of mild cognitive impairment (MCI) or early dementia due to AD.

methodsA 1:1 multicenter randomized controlled phase 2 trial, ages 45-90 with MCI or early dementia due to AD and a Montreal Cognitive Assessment (MoCA) score of 18 or higher. The primary outcome measures were changes in cognition and function tests: Clinical Global Impression of Change (CGIC), Alzheimer's Disease Assessment Scale (ADAS-Cog), Clinical Dementia Rating-Sum of Boxes (CDR-SB), and Clinical Dementia Rating Global (CDR-G) after 20 weeks of an intensive multidomain lifestyle intervention compared to a wait-list usual care control group. ADAS-Cog, CDR-SB, and CDR-Global scales were compared using a Mann-Whitney-Wilcoxon rank-sum test, and CGIC was compared using Fisher's exact test. Secondary outcomes included plasma Aβ42/40 ratio, other biomarkers, and correlating lifestyle with the degree of change in these measures.

resultsFifty-one AD patients enrolled, mean age 73.5. No significant differences in any measures at baseline. Only two patients withdrew. All patients had plasma Aβ42/40 ratios <0.0672 at baseline, strongly supporting AD diagnosis. After 20 weeks, significant between-group differences in the CGIC (p= 0.001), CDR-SB (p= 0.032), and CDR Global (p= 0.037) tests and borderline significance in the ADAS-Cog test (p= 0.053). CGIC, CDR Global, and ADAS-Cog showed improvement in cognition and function and CDR-SB showed significantly less progression, compared to the control group which worsened in all four measures. Aβ42/40 ratio increased in the intervention group and decreased in the control group (p = 0.003). There was a significant correlation between lifestyle and both cognitive function and the plasma Aβ42/40 ratio. The microbiome improved only in the intervention group (p <0.0001).

conclusionsComprehensive lifestyle changes may significantly improve cognition and function after 20 weeks in many patients with MCI or early dementia due to AD.

trial registrationApproved by Western Institutional Review Board on 12/31/2017 (#20172897) and by Institutional Review Boards of all sites. This study was registered retrospectively with clinicaltrials.gov on October 8, 2020 (NCT04606420, ID: 20172897).

Indexed as

Alzheimer DiseaseCognitive DysfunctionDisease ProgressionLife StyleAgedAged, 80 and overAmyloid beta-PeptidesDementiaFemaleHumansMaleMiddle AgedNeuropsychological TestsTreatment OutcomeAmyloid beta-PeptidesAlzheimer’sDietExerciseLifestyle medicineNutritionSocial supportStress management

Identifiers

PMID38849944
PMCPMC11157928

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.