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

NCT ID: NCT06538116

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mevidalen (high dose)

Mevidalen high dose administered orally.

Group Type EXPERIMENTAL

Mevidalen

Intervention Type DRUG

Administered orally

Mevidalen (low dose)

Mevidalen low dose administered orally.

Group Type EXPERIMENTAL

Mevidalen

Intervention Type DRUG

Administered orally

Placebo

Placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Mevidalen

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3154207

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status RECRUITING

Baptist Health Center for Clinical Research LLC

Little Rock, Arkansas, United States

Site Status RECRUITING

Profound Research LLC At The Neurology Center of Southern California

Carlsbad, California, United States

Site Status RECRUITING

Neuropain Medical Center

Fresno, California, United States

Site Status RECRUITING

Catalina Research Institute

Montclair, California, United States

Site Status NOT_YET_RECRUITING

California Neuroscience Research, LLC

Sherman Oaks, California, United States

Site Status RECRUITING

JEM Research Institute

Atlantis, Florida, United States

Site Status RECRUITING

Visionary Investigators Network

Aventura, Florida, United States

Site Status RECRUITING

Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research

Boca Raton, Florida, United States

Site Status RECRUITING

Vertex Clinical Research

Clermont, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status RECRUITING

Merritt Island Medical Research, LLC dba Flourish Research

Merritt Island, Florida, United States

Site Status RECRUITING

Visionary Investigators Network

Miami, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research - New Port Richey

New Port Richey, Florida, United States

Site Status RECRUITING

Renstar Medical Research

Ocala, Florida, United States

Site Status RECRUITING

Charter Research, LLC

Orlando, Florida, United States

Site Status RECRUITING

Progressive Medical Research

Port Orange, Florida, United States

Site Status RECRUITING

Intercoastal Medical Group

Sarasota, Florida, United States

Site Status RECRUITING

Brain Matters Research

Stuart, Florida, United States

Site Status RECRUITING

Charter Research - The Villages

The Villages, Florida, United States

Site Status RECRUITING

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

Site Status RECRUITING

Conquest Research

Winter Park, Florida, United States

Site Status RECRUITING

Accel Research Sites - NeuroStudies CRU

Decatur, Georgia, United States

Site Status RECRUITING

CenExel iResearch Atlanta

Decatur, Georgia, United States

Site Status RECRUITING

CenExel iResearch, LLC

Savannah, Georgia, United States

Site Status RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Site Status RECRUITING

Ascension Alexian Brothers

Elk Grove Village, Illinois, United States

Site Status RECRUITING

Josephson, Wallack, Munshower Neurology, P.C.

Indianapolis, Indiana, United States

Site Status RECRUITING

ActivMed Practices & Research, LLC

Methuen, Massachusetts, United States

Site Status RECRUITING

QUEST Research Institute

Farmington Hills, Michigan, United States

Site Status RECRUITING

CenExel Advanced Memory Research Institute of NJ

Toms River, New Jersey, United States

Site Status RECRUITING

AMC Research, LLC dba Flourish Research

Matthews, North Carolina, United States

Site Status RECRUITING

Eximia Clinical Research-NC, LLC

Raleigh, North Carolina, United States

Site Status RECRUITING

Keystone Clinical Studies, LLC Philadelphia dba Flourish Research

Plymouth Meeting, Pennsylvania, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc.Ta

Memphis, Tennessee, United States

Site Status RECRUITING

Senior Adults Specialty Research

Austin, Texas, United States

Site Status RECRUITING

Kerwin Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Cedar Health Research, LLC

Euless, Texas, United States

Site Status RECRUITING

Clinical Trial Network LLC

Houston, Texas, United States

Site Status RECRUITING

El Faro Health and Therapeutics

Rio Grande City, Texas, United States

Site Status RECRUITING

Be Well Clinical Studies

Round Rock, Texas, United States

Site Status RECRUITING

Clinical Trials of Texas, LLC San Antonio dba Flourish Research

San Antonio, Texas, United States

Site Status NOT_YET_RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Akita City Hospital

Akita, , Japan

Site Status RECRUITING

Memory Clinic Ochanomizu

Bunkyō City, , Japan

Site Status RECRUITING

Inage Neurology and Memory Clinic

Chiba, , Japan

Site Status RECRUITING

Ikuseikai Shinozuka Hospital

Fujioka-shi, , Japan

Site Status RECRUITING

Mental Clinic Sakurazaka

Fukuoka, , Japan

Site Status RECRUITING

Kuramitsu Hospital

Fukuoka, , Japan

Site Status RECRUITING

Himeji Central Hospital Clinic

Himeji-shi, , Japan

Site Status RECRUITING

Koseikai Cocoro Hospital Kusatsu

Hiroshima, , Japan

Site Status RECRUITING

NHO Hizen Psychiatric Medical Center

Kanzaki-gun, , Japan

Site Status RECRUITING

Rainbow & Sea Hospital

Karatsu-shi, , Japan

Site Status RECRUITING

Kishikai Kishi Hospital

Kiryu-shi, , Japan

Site Status RECRUITING

Southern TOHOKU Medical Clinic

Koriyama-shi, , Japan

Site Status RECRUITING

Katayama Medical Clinic

Kurashiki-shi, , Japan

Site Status RECRUITING

Mabashi Clinic

Matsudo-shi, , Japan

Site Status RECRUITING

National Center for Geriatrics and Gerontology

Obu-shi, , Japan

Site Status RECRUITING

Tokyo Medical University Hospital

Shinjuku-ku, , Japan

Site Status RECRUITING

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, , Japan

Site Status RECRUITING

Memory Clinic Toride

Toride-shi, , Japan

Site Status RECRUITING

Yamagata University Hospital

Yamagata, , Japan

Site Status RECRUITING

Oita University Hospital

Yufu-shi, , Japan

Site Status RECRUITING

Countries

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United States Japan

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Related Links

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https://trials.lilly.com/en-US/trial/524115

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

Other Identifiers

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I7S-MC-HBEO

Identifier Type: OTHER

Identifier Source: secondary_id

18822

Identifier Type: -

Identifier Source: org_study_id