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Can Lifestyle Changes Reverse Early-Stage 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

No Placebo-Only Group

Summary

This trial tests if making significant lifestyle changes can slow, stop, or reverse early-stage Alzheimer's disease. It involves patients adopting healthier habits like better diet, regular exercise, stress management, and social activities to improve brain health.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and also after 20 weeks, 40 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Amyloid peptides

Angiogenesis biomarkers

Changes from baseline in biomarkers

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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