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Precision Medicine for Dementia (EVANTHEA Trial)

Phase 3
Waitlist Available
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

EVANTHEA 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.Check my eligibility
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.See study design
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.

EVANTHEA Trial 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.

EVANTHEA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in mean CNS Vital Signs Neurocognitive Index Scores over 9 months
Changes in mean Montreal Cognition Assessment (MoCA) scores over 9 months
Secondary outcome measures
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 outcome measures
Change in serum biomarker, methylation epigenetics.
Changes in serum biomarker, P-tau.
Changes over time in findings on volumetric magnetic resonance imaging (MRI).

EVANTHEA 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

Find a Location

Who is running the clinical trial?

Alzheimer's Prevention and Reversal Project, Inc.Lead Sponsor
Four Winds FoundationUNKNOWN
Dale Bredesen, MDStudy ChairAlzheimer's Prevention and Reversal Project, Inc.

Media Library

Precision Medicine Approach Clinical Trial Eligibility Overview. Trial Name: NCT05894954 — Phase 3
Mild Cognitive Impairment Research Study Groups: Group A (Precision Medicine), Group B (Standard-of-Care)
Mild Cognitive Impairment Clinical Trial 2023: Precision Medicine Approach Highlights & Side Effects. Trial Name: NCT05894954 — Phase 3
Precision Medicine Approach 2023 Treatment Timeline for Medical Study. Trial Name: NCT05894954 — Phase 3

Frequently Asked Questions

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

What are the main aims of this clinical trial?

"The primary outcome of this study, which is assessed at Baseline and Months 3, 6, and 9 (end of study treatment) will be Changes in the mean CNS Vital Signs Neurocognitive Index Scores over a nine month period. Secondary objectives include changes in the mean PROMIS-10 score through time while comparing groups A & B treatments; discontinuation rates to measure acceptability of precision medicine interventions ; and safety assessments based on type, frequency, severity, relatedness & expectedness for adverse events or serious adverse events. The PROMIS Global-10 comprises 10 items rated across 5 points (or 11 point rating scales). Each"

Answered by AI

Are there currently openings for individuals to join this clinical trial?

"Clinicaltrials.gov does not list this study as actively recruiting patients; it was posted on June 12th 2023 and last updated on May 30th 2023. Despite the lack of current enrollment, there are 934 other clinical trials that have open recruitment at present."

Answered by AI

What are the known risks associated with Group A precision medicines?

"Our analysts at Power have concluded that Group A (Precision Medicine) has a safety rating of 3, in light of the evidence gathered during Phase 3 trials showing efficacy and multiple rounds verifying its security."

Answered by AI

Are senior citizens excluded from participating in this medical experiment?

"For this research, individuals aged 45 and up to 76 years old are encouraged to participate."

Answered by AI

Are there any qualifications which would allow me to partake in this clinical research?

"This clinical trial is in search of 72 participants with mild cognitive impairment aged between 45 and 76. Eligible applicants must meet these criteria to be accepted into the study."

Answered by AI

Are there any locations in North America where this trial is being conducted?

"Ann Hathaway, MD in San Rafael, Bay Area Wellness in Walnut Creek, and Rezilir Health in Hollywood are a few of the six medical centres that have begun recruiting patients for this trial."

Answered by AI

Who else is applying?

What site did they apply to?
True Health Center for Functional Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
2023. "Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05894954.
All > Mild Cognitive Impairment
~17 spots leftby Aug 2024
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