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

Last updated: February 26, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Mevidalen

Clinical Study ID

NCT06538116
18822
I7S-MC-HBEO
  • Ages 50-80
  • All Genders

Study 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 Criteria

Inclusion

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 toparticipate, is in frequent contact with the participant and will be available atdesignated times.

  • Males with partners of childbearing potential must agree to abide with providedcontraception guidance.

Exclusion

Exclusion Criteria:

  • Are individuals of childbearing potential.

  • Have significant central nervous system or psychiatric disease, other than AD, thatin the investigator's opinion may affect cognition or the ability to complete thestudy (e.g: head trauma, stroke, seizure disorder etc.,).

  • Have cardiovascular-related risk factors or history that include uncontrolledhypertension, 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 aninvestigational product.

  • Participant is, in the judgment of the investigator, actively suicidal and thereforedeemed to be at significant risk for suicide.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 26, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • National Center for Geriatrics and Gerontology

    Obu, Aichi 474-8511
    Japan

    Active - Recruiting

  • Inage Neurology and Memory Clinic

    Inage, Chiba 263-0043
    Japan

    Active - Recruiting

  • Mabashi Clinic

    Matsudo-shi, Chiba-Ken 271-0047
    Japan

    Active - Recruiting

  • Mental Clinic Sakurazaka

    Fukuoka-shi, Fukuoka-Ken 810-0023
    Japan

    Active - Recruiting

  • Kuramitsu Hospital

    Fukuoka-shi, Fukuoka-ken 819-0037
    Japan

    Active - Recruiting

  • Southern TOHOKU Medical Clinic

    Koriyama-shi, Fukushima-Ken 963-8563
    Japan

    Active - Recruiting

  • Ikuseikai Shinozuka Hospital

    Fujioka-shi, Gunma-Ken 375-0017
    Japan

    Site Not Available

  • Medical Corporation Kishikai Kishi Hospital

    Kiryu-shi, Gunma-Ken 376-0011
    Japan

    Active - Recruiting

  • Cocoro Hospital Kusatsu

    Hiroshima-shi, Hiroshima-Ken 733-0864
    Japan

    Site Not Available

  • Himeji Central Hospital Affiliated Clinic

    Himeji, Hyogo 672-8043
    Japan

    Site Not Available

  • Memory Clinic Toride

    Toride, Ibaraki 302-0004
    Japan

    Active - Recruiting

  • Oita University Hospital

    Yufu, Oita 879-5593
    Japan

    Active - Recruiting

  • Katayama Medical Clinic

    Kurashiki, Okayama 710-0813
    Japan

    Active - Recruiting

  • NHO Hizen Psychiatric Center

    Kanzaki-gun, Saga-Ken 842-0192
    Japan

    Active - Recruiting

  • Rainbow & Sea Hospital

    Karatsu-shi, Saga-Ken 847-0031
    Japan

    Site Not Available

  • Memory Clinic Ochanomizu

    Bunkyo-ku, Tokyo 113-0034
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Akita City Hospital

    Akita, 010-0933
    Japan

    Site Not Available

  • Tokyo Metro Bokutoh Hospital

    Sumida-ku, 130-8575
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Profound Research, LLC

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Active - Recruiting

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Vertex Clinical Research

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Suncoast Clinical Research

    New Port Richey, Florida 34652
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Charter Research

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Intercoastal Medical Group - Hyde Park

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Brain Matters Research

    Stuart, Florida 34997
    United States

    Active - Recruiting

  • Charter Research, LLC

    The Villages, Florida 32162
    United States

    Active - Recruiting

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Conquest Clinical Research, LLC

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • NeuroStudies

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois 60007
    United States

    Active - Recruiting

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Active - Recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan 49334
    United States

    Active - Recruiting

  • CenExel Advanced Memory Research Institute of NJ

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • AMC Research

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • Eximia Research-NC, LLC

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Cedar Health Research LLC

    Arlington, Texas 76040
    United States

    Active - Recruiting

  • Senior Adults Specialty Research

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • El Faro Health and Therapeutics

    Rio Grande City, Texas 78582
    United States

    Active - Recruiting

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Washington - Harborview Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

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