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A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease | Clinical Trials | Clareo Health

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A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease

A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease

NCT06538116•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living.
•Have MMSE score of 13 to 24.
•Have eligibile plasma P-tau or historical evidence of AD pathology.
•Have a reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant and will be available at designated times.
•Males with partners of childbearing potential must agree to abide with provided contraception guidance.

Exclusion Criteria

•Are individuals of childbearing potential.
•Have significant central nervous system or psychiatric disease, other than AD, that in the investigator's opinion may affect cognition or the ability to complete the study (e.g: head trauma, stroke, seizure disorder etc.,).
•Have cardiovascular-related risk factors or history that include uncontrolled hypertension, heart failure, stroke; or liver-related abnormalities.
•Use of moderate or strong CYP3A4 inhibitors or inducers.
•Have participated within the last 30 days in a clinical trial involving an investigational product.
•Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

Locations (64)

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Baptist Health Center for Clinical Research LLC

Little Rock, Arkansas, United States

Profound Research LLC At The Neurology Center of Southern California

Carlsbad, California, United States

Neuropain Medical Center

Fresno, California, United States

Catalina Research Institute

Montclair, California, United States

California Neuroscience Research, LLC

Sherman Oaks, California, United States

JEM Research Institute

Atlantis, Florida, United States

Visionary Investigators Network

Aventura, Florida, United States

Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research

Boca Raton, Florida, United States

Vertex Clinical Research

Clermont, Florida, United States

Key Dates

Start Date

August 26, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

December 17, 2025

Enrollment

300

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

Mevidalen

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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