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Precision Medicine for Dementia (EVANTHEA Trial)

Phase 3

Recruiting

Led By Kat Toups, MD

Research Sponsored by Alzheimer's Prevention and Reversal Project, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Provide signed informed consent

Adults of any gender, race, or ethnicity and aged 45 to 76 years at time of enrollment

Timeline

Screening 90 days

Treatment 9 months

Follow Up baseline and months 3, 6, and 9 (end of study treatment)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares a precision medicine approach to standard-of-care in people with mild cognitive impairment or early-stage dementia to see if it can improve memory. Participants are randomly assigned to either group and monitored over 9 months.

Who is the study for?

This trial is for adults aged 45-76 with early dementia or mild cognitive impairment who can follow a treatment plan including diet, lifestyle changes, and medications. They need to have a supportive partner, live close to the study site, be proficient in English, use a computer/smartphone, and agree to home evaluations. Excluded are those with major psychiatric issues unrelated to cognitive decline or severe brain injury.

What is being tested?

The trial tests if personalized medicine based on extensive lab tests improves memory better than standard care over nine months. Participants will receive tailored treatments involving hormones, medications, stress management devices and brain exercises versus standard lifestyle advice.

What are the potential side effects?

Potential side effects may include reactions related to dietary changes (like digestive discomfort), stress from adapting new routines or technologies used in the study. Specific medication-related side effects depend on individual prescriptions but could involve typical drug risks like allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 76 years old.

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I have mild cognitive issues or early dementia, confirmed by specific test scores.

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I have someone who can help me follow the study rules and knows about my memory issues.

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I can talk to a coach or doctor online for my treatment.

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I am open to a health coach visiting my home for an evaluation.

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I am willing to address and/or move away from environments with mold, toxins, infections, or dental decay.

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You must be willing to undergo an MRI and a special scan to check your heart arteries.

Timeline

Screening ~ 90 days0 visits

Treatment ~ 9 months9 visits

Follow Up ~ baseline and months 3, 6, and 9 (end of study treatment)

Screening ~ 90 days

Treatment ~ 9 months

Follow Up ~baseline and months 3, 6, and 9 (end of study treatment)

This trial's timeline: 90 days for screening, 9 months for treatment, and baseline and months 3, 6, and 9 (end of study treatment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in mean CNS Vital Signs Neurocognitive Index Scores over 9 months

Changes in mean Montreal Cognition Assessment (MoCA) scores over 9 months

Secondary study objectives

Changes over time in mean score on the Alzheimer's Questionnaire-21 (AQ-21) / Alzheimer's Questionnaire-20 (AQ-20)

Changes over time in mean score on the Patient-reported Outcome Measurement Information System (PROMIS-10).

Discontinuation rates

+1 more

Other study objectives

Change in serum biomarker, methylation epigenetics.

Changes in serum biomarker, P-tau.

Changes over time in findings on volumetric magnetic resonance imaging (MRI).

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A (Precision Medicine)Experimental Treatment3 Interventions

Precision Medicine approach starts with a battery of tests and questionnaires to determine a person's underlying causes of cognition impairment. A custom treatment program is developed and prescribed by the investigator based on the test results and includes a combination of: supplements, medications, hormone therapy, dietary changes, exercise program, brain exercises, stress management, sleep tracking. Additional treatments may include QEEG and photobiomodulation, neurostimulation, neurofeedback and/or hyperbaric oxygen treatment (additional treatment are only available at select sites). Participants in this Group will also be supported in their program by a nutritionist, health coach, and fitness trainer, in addition to the study doctor. Tracking of study activities may also be required in the form of diaries, and devices will be used to track some of their activities such as sleep, stress, diet and exercise.

Group II: Group B (Standard-of-Care)Active Control1 Intervention

Standard-of-care treatment will be based on the practice guideline of hte Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Participants in this group will be guided according to the recommendations which include recommending: * participation in cognitively and socially-stimulation activities * regular exercise * ensuring quality sleep including treatment of any sleep apnea * control of any modifiable risk factors such as blood pressure, diabetes, cholesterol, and avoidance of tobacco use * evaluation by a primary care physician * adherence to a healthy and balanced diet * consult a neurologist or primary care physician regarding use of medications * consult with their primary care physician to identify any worsening conditions

0 / 14Eligibility criteria met