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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Placebo; Drug: Mevidalen

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-0933
    • Akita City Hospital
  • Bunkyō City, Japan, 113-0034
    • Memory Clinic Ochanomizu
  • Chiba, Japan, 263-0043
    • Inage Neurology and Memory Clinic
  • Fujioka-shi, Japan, 375-0017
    • Ikuseikai Shinozuka Hospital
  • Fukuoka, Japan, 819-0037
    • Kuramitsu Hospital
  • Fukuoka, Japan, 810-0023
    • Mental Clinic Sakurazaka
  • Himeji-shi, Japan, 672-8043
    • Himeji Central Hospital Clinic
  • Hiroshima, Japan, 733-0864
    • Koseikai Cocoro Hospital Kusatsu
  • Kanzaki-gun, Japan, 842-0192
    • NHO Hizen Psychiatric Medical Center
  • Karatsu-shi, Japan, 847-0031
    • Rainbow & Sea Hospital
  • Kiryu-shi, Japan, 376-0011
    • Kishikai Kishi Hospital
  • Koriyama-shi, Japan, 963-8563
    • Southern TOHOKU Medical Clinic
  • Kurashiki-shi, Japan, 710-0813
    • Katayama Medical Clinic
  • Matsudo-shi, Japan, 271-0047
    • Mabashi Clinic
  • Obu-shi, Japan, 474-8511
    • National Center for Geriatrics and Gerontology
  • Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Sumida-ku, Japan, 130-8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Toride-shi, Japan, 302-0004
    • Memory Clinic Toride
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Yufu-shi, Japan, 879-5593
    • Oita University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research LLC
  • California
    • Carlsbad, California, United States, 92011
      • Profound Research LLC at The Neurology Center of Southern California
    • Fresno, California, United States, 93710
      • Neuropain Medical Center
    • Montclair, California, United States, 91763
      • Catalina Research Institute
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research, LLC
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Aventura, Florida, United States, 33180
      • Visionary Investigators Network
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research
    • Clermont, Florida, United States, 34711
      • Vertex Clinical Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Merritt Island, Florida, United States, 32952
      • Merritt Island Medical Research, LLC dba Flourish Research
    • Miami, Florida, United States, 33176
      • Visionary Investigators Network
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research - New Port Richey
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32803
      • Charter Research, LLC
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group
    • Stuart, Florida, United States, 34997
      • Brain Matters Research
    • The Villages, Florida, United States, 32162
      • Charter Research - The Villages
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute at Palm Beach Neurology
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Georgia
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch Atlanta
    • Decatur, Georgia, United States, 30030
      • Accel Research Sites - NeuroStudies CRU
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Ascension Alexian Brothers
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Josephson, Wallack, Munshower Neurology, P.C.
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, LLC
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • CenExel Advanced Memory Research Institute of NJ
  • North Carolina
    • Matthews, North Carolina, United States, 28105
      • AMC Research, LLC dba Flourish Research
    • Raleigh, North Carolina, United States, 27612
      • Eximia Clinical Research-NC, LLC
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Keystone Clinical Studies, LLC Philadelphia dba Flourish Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.Ta
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Dallas, Texas, United States, 75231
      • Kerwin Medical Center
    • Euless, Texas, United States, 76040
      • Cedar Health Research, LLC
    • Houston, Texas, United States, 77074
      • Clinical Trial Network LLC
    • Rio Grande City, Texas, United States, 78582
      • El Faro Health and Therapeutics
    • Round Rock, Texas, United States, 78681
      • Be Well Clinical Studies
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC San Antonio dba Flourish Research
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally.	Drug: Placebo; Administered orally
Experimental: Mevidalen (high dose); Mevidalen high dose administered orally.	Drug: Mevidalen; Administered orally; Other Names: LY3154207
Experimental: Mevidalen (low dose); Mevidalen low dose administered orally.	Drug: Mevidalen; Administered orally; Other Names: LY3154207

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)	iADRS assesses the impact of cognitive loss on everyday activities and provides a measure of global AD severity as a single summary score. It comprises of 2 underlying domains "cognitive ability" and "functional ability," and integrates the items in both the domains a single overall score ranging from 0 to 144, with lower scores indicating worse performance.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)	The ADAS-Cog13 consists of 13 items which assess the areas of cognitive function that are the most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, and digit cancellation measures. The scale ranges from 0 to 85, with higher scores indicating greater disease severity.	Baseline, Week 24
Change from Baseline in Verbal Fluency Test	The Verbal Fluency Test, also known as the FAS test, requires participants to say as many words as possible beginning with specific letters (F, A, and S) in 1 minute. The FAS score corresponds to the number of words generated by each participant under each letter category within 1 minute. A higher score indicates better performance.	Baseline, Week 24
Change from Baseline in Category Fluency Test	The Category Fluency test is a measure of semantic memory and involves planning, organization, and cognitive flexibility. The participant is asked to generate as many words as possible in 1 minute that belong to the animal semantic category. Total score is the sum of correct words generated for the animal category, and higher values indicate better performance.	Baseline, Week 24
Change from Baseline in Digit Symbol Coding Test( Wechsler Adult Intelligence Scale-IV)(WAIS-IV)	The Digit Symbol-Coding test from the WAIS-IV involves testing processing speed among subjects; The digit symbol coding requires a subject to match symbols to numbers according to a key. The number of correct symbols within the allowed time constitutes the score, and higher values indicate better performance.	Baseline, Week 24
Change from Baseline in Mini Mental State Examination (MMSE)	The MMSE is a brief instrument used to assess global cognition. The instrument measures orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with lower score indicating greater level of impairment.	Baseline, Week 24
Change from Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)	The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire that is to be answered by the participant's study partner. Study partner is asked to observe and rate the performance of activities of daily living attempted by participants. The range for the total ADCS-ADL score is 0 to 78, with lower scores indicating greater level of impairment.	Baseline, Week 24
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change score (ADCS-CGIC)	The ADCS-CGIC is a 7-point, categorical scale that provides a single global rating of change from baseline. A score of 1 indicates marked improvement; a score of 2, moderate improvement; a score of 3, minimal improvement; a score of 4, no change; a score of 5, minimal worsening; a score of 6, moderate worsening; and a score of 7, marked worsening.	Week 24
Change from Baseline on Neuropsychiatric Inventory (NPI-12)	The NPI-12 is rating instrument to assess abnormal behaviors in dementia patients by informant-based interview that utilizes scripted questions to explore 12 different symptom domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioral disturbances, and appetite and eating abnormalities. The frequency of behaviour is scored from 0 (Rarely) to 4 (very often) and the severity from 0 (mild) to 3 (severe). A total score for each symptom is calculated by multiplying the frequency rating by the severity rating. The total NPI-12 score is the sum of all symptom scores and ranges from 0 to 144, with higher scores indicating a greater degree of symptomatology.	Baseline, Week 24
Change from Baseline on Epworth Sleepiness Scale (ESS)	ESS is an 8-item questionnaire that measures the chances of "dozing off" in different daytime situations over the past week. Scores range from 0 to 24, with scores greater than or equal to 10 indicating excessive daytime sleepiness.	Baseline, Week 24
Change from Baseline on Quick Dementia Rating Scale (QDRS)	The QDRS is a 10-item rating scale that assesses aspects of cognition, behavior, and daily functioning on a 5-point scale where no problems = 0, slight problems = 0.5, mild problems = 1, moderate to severe problems = 2, and severe problems = 3. Total scores range from 0 to 30 and higher scores indicate increased cognitive impairment.	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Substandard Drugs; Pharmaceutical Preparations; LY3154207
• Other Study ID Numbers: 18822; I7S-MC-HBEO (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No