WELCOME TO
THE EVANTHEA DEMENTIA REVERSAL TRIAL
Exploratory analyses showed improvements beyond cognition to include improvements in blood pressure, weight, cholesterol and additional markers for pre-diabetes.
There was a statistically significant improvement of greater than one standard deviation in cognitive scores as measured by CNS Vital Signs (CNSVS), the primary endpoint of the study (Exhibit 1). Statistically significant improvements were documented for memory, executive function, brain processing speed, and overall cognitive index. The additional primary endpoint of Montreal Cognitive Assessment (MoCA) scores showed a trend to improvement but did not reach statistical significance (p = 0.154) although both groups improved throughout the trial.
In addition to these improved cognitive findings, those treated with the personalized precision medicine approach showed statistically significant changes, including in blood pressure (both systolic and diastolic), weight (body mass index), hemoglobin A1c (a measure of glucose control), lipid profiles and other health parameters.
Results will be submitted for peer-reviewed publication and presentation at an upcoming medical congress.
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The Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (EVANTHEA) physicians have concluded the randomized controlled trial and want to thank the patients and sponsors who made this possible. An accompanying preprint manuscript detailing results demonstrating unprecedented improvements in cognitive function using a personalized precision medicine approach is now publicly available on PrePrints.org.
The EVANTHEA trial enrolled 73 patients and utilized a 2:1 randomized design, comparing precision medicine treatment to standard-of-care treatment. Participants underwent comprehensive assessments and testing protocols. The active treatment precision medicine group adopted a plant-rich mildly ketogenic diet, regular exercise (both aerobic and strength training), optimized sleep parameters, and lifestyle interventions, with additional treatment strategies that were individualized for each patient based on their unique biological drivers of cognitive decline, such as identified problems with lipids, blood sugar, inflammation, chronic infections, immune issues, nutrient and hormone deficiencies, or various toxin accumulations. The standard-of-care subjects underwent currently accepted treatment at the direction of their primary care physician or neurologist.
Trial shows success of personalized, comprehensive approach
Trial shows success of personalized, comprehensive approach.
These findings are based on a preprint that has not yet undergone peer review. The intervention evaluated in the EVANTHEA trial is not approved by the U.S. Food and Drug Administration for the treatment, cure, or prevention of Alzheimer’s disease, mild cognitive impairment, or dementia. This summary is provided for scientific and informational purposes only and is not intended as medical advice.
More information on the EVANTHEA trial is available on ClinicalTrials.gov. The EVANTHEA trial was made possible by Evanthea, LLC, with the support of the Four Winds Foundation and the Alzheimer’s Prevention and Reversal Project (APRP).
Hear from Our Lead Advisor About The Trial
The Latest Alzheimer’s Clinical Trial Results
Dale Bredesen, MD serves as the lead study advisor for the EVANTHEA trial and is an internationally recognized neurologist with specialty expertise in the mechanisms of neurodegenerative diseases. He is the Senior Director of Precision Brain Health at Pacific Neuroscience Institute and the Chief Scientific Officer at Apollo Health. Read more about him here.
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