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Lifestyle medicine for Alzheimer's Disease

N/A
Waitlist Available
Led By Dean Ornish, MD
Research Sponsored by Preventive Medicine Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and also after 20 weeks, 40 weeks.
Awards & highlights

Study Summary

This trial will test if making lifestyle changes can help people with early Alzheimer's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and also after 20 weeks, 40 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and also after 20 weeks, 40 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score
Change from Baseline in Clinical Global Impression of Change (CGIC) score
Secondary outcome measures
Amyloid peptides
Angiogenesis biomarkers
Changes from baseline in biomarkers
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (Intervention) GroupExperimental Treatment1 Intervention
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.
Group II: Control (Non-Intervention) GroupActive Control1 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.

Find a Location

Who is running the clinical trial?

Renown HealthOTHER
2 Previous Clinical Trials
5,155 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
195 Previous Clinical Trials
1,315,994 Total Patients Enrolled
University of California, San FranciscoOTHER
2,505 Previous Clinical Trials
15,237,504 Total Patients Enrolled

Media Library

Lifestyle medicine Clinical Trial Eligibility Overview. Trial Name: NCT04606420 — N/A
Alzheimer's Disease Research Study Groups: Experimental (Intervention) Group, Control (Non-Intervention) Group
Alzheimer's Disease Clinical Trial 2023: Lifestyle medicine Highlights & Side Effects. Trial Name: NCT04606420 — N/A
Lifestyle medicine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04606420 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are novel participants able to join this experiment?

"Unfortunately, the information located on clinicaltrials.gov states that this medical trial is no longer accepting patients. The study was posted in September 2018 and its last update occurred 4 years later; however, there are over 500 other studies actively seeking enrollees at this time."

Answered by AI

Do minors meet the criteria to be included in this experiment?

"This medical study is recruiting patients aged 45 and above, with a cut-off at 90 years old."

Answered by AI

Are there any Canadian medical centers running this clinical experiment?

"Presently, 5 medical centres are running this clinical trial with sites in Sausalito, Reno and Boston amongst others. To reduce travel needs if you choose to enroll in the study, it is advantageous to pick a centre that is nearest your current location."

Answered by AI

To which demographic is this research study accessible?

"This research project is enrolling 51 individuals aged between 45 and 90 with alzheimer disease. To be considered, candidates must have a current diagnosis of mild dementia or cognitive impairment due to the condition in question (McKhann-Albert criteria) as well as a MoCA score above 17 (18+). Additionally, they are expected to partake in all parts of this intervention while having access to an associate who can provide corroborating information and aid them through the study's duration."

Answered by AI

What outcomes is this research endeavor attempting to accomplish?

"This clinical trial seeks to measure the change in Clinical Global Impression of Change (CGIC) score at baseline and after 20 weeks and 40 weeks. Secondary objectives involve quantifying changes from baseline in patients' gut microbiomes, amyloid peptides, and inflammatory biomarkers with 16S rRNA amplicon sequencing, metagenomic sequencing, mass spectrometry testing via Human Aβ Peptide Panel 1 (6E10), Phospho(Thr231)/Total Tau Kit; p-tau 181; p-tau217., as well as Inflammatory Human ProInflammatory 10-Plex: IF"

Answered by AI
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~8 spots leftby Apr 2025