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

NCT06538116 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 18822I7S-MC-HBEO
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 64

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)

  Baseline, Week 24

• Change from Baseline in Verbal Fluency Test

  Baseline, Week 24

• Change from Baseline in Category Fluency Test

  Baseline, Week 24

• Change from Baseline in Digit Symbol Coding Test( Wechsler Adult Intelligence Scale-IV)(WAIS-IV)

  Baseline, Week 24

• Change from Baseline in Mini Mental State Examination (MMSE)

  Baseline, Week 24

Study Arms (3)

Mevidalen (high dose)

EXPERIMENTAL

Mevidalen high dose administered orally.

Drug: Mevidalen

Mevidalen (low dose)

EXPERIMENTAL

Mevidalen low dose administered orally.

Drug: Mevidalen

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

Mevidalen DRUG

Administered orally

Also known as: LY3154207

Mevidalen (high dose); Mevidalen (low dose)

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (64)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Baptist Health Center for Clinical Research LLC

Little Rock, Arkansas, 72205, United States

Location

Profound Research LLC At The Neurology Center of Southern California

Carlsbad, California, 92011, United States

Location

Neuropain Medical Center

Fresno, California, 93710, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

California Neuroscience Research, LLC

Sherman Oaks, California, 91403, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, United States

Location

Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research

Boca Raton, Florida, 33434, United States

Location

Vertex Clinical Research

Clermont, Florida, 34711, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Merritt Island Medical Research, LLC dba Flourish Research

Merritt Island, Florida, 32952, United States

Location

Visionary Investigators Network

Miami, Florida, 33176, United States

Location

Suncoast Clinical Research - New Port Richey

New Port Richey, Florida, 34652, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Charter Research, LLC

Orlando, Florida, 32803, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Intercoastal Medical Group

Sarasota, Florida, 34239, United States

Location

Brain Matters Research

Stuart, Florida, 34997, United States

Location

Charter Research - The Villages

The Villages, Florida, 32162, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Accel Research Sites - NeuroStudies CRU

Decatur, Georgia, 30030, United States

Location

CenExel iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

Ascension Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

Location

Josephson, Wallack, Munshower Neurology, P.C.

Indianapolis, Indiana, 46256, United States

Location

ActivMed Practices & Research, LLC

Methuen, Massachusetts, 01844, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

CenExel Advanced Memory Research Institute of NJ

Toms River, New Jersey, 08755, United States

Location

AMC Research, LLC dba Flourish Research

Matthews, North Carolina, 28105, United States

Location

Eximia Clinical Research-NC, LLC

Raleigh, North Carolina, 27612, United States

Location

Keystone Clinical Studies, LLC Philadelphia dba Flourish Research

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Clinical Neuroscience Solutions, Inc.Ta

Memphis, Tennessee, 38119, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Kerwin Medical Center

Dallas, Texas, 75231, United States

Location

Cedar Health Research, LLC

Euless, Texas, 76040, United States

Location

Clinical Trial Network LLC

Houston, Texas, 77074, United States

Location

El Faro Health and Therapeutics

Rio Grande City, Texas, 78582, United States

Location

Be Well Clinical Studies

Round Rock, Texas, 78681, United States

Location

Clinical Trials of Texas, LLC San Antonio dba Flourish Research

San Antonio, Texas, 78229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

Akita City Hospital

Akita, 010-0933, Japan

Location

Memory Clinic Ochanomizu

Bunkyō City, 113-0034, Japan

Location

Inage Neurology and Memory Clinic

Chiba, 263-0043, Japan

Location

Ikuseikai Shinozuka Hospital

Fujioka-shi, 375-0017, Japan

Location

Mental Clinic Sakurazaka

Fukuoka, 810-0023, Japan

Location

Kuramitsu Hospital

Fukuoka, 819-0037, Japan

Location

Himeji Central Hospital Clinic

Himeji-shi, 672-8043, Japan

Location

Koseikai Cocoro Hospital Kusatsu

Hiroshima, 733-0864, Japan

Location

NHO Hizen Psychiatric Medical Center

Kanzaki-gun, 842-0192, Japan

Location

Rainbow & Sea Hospital

Karatsu-shi, 847-0031, Japan

Location

Kishikai Kishi Hospital

Kiryu-shi, 376-0011, Japan

Location

Southern TOHOKU Medical Clinic

Koriyama-shi, 963-8563, Japan

Location

Katayama Medical Clinic

Kurashiki-shi, 710-0813, Japan

Location

Mabashi Clinic

Matsudo-shi, 271-0047, Japan

Location

National Center for Geriatrics and Gerontology

Obu-shi, 474-8511, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023, Japan

Location

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, 130-8575, Japan

Location

Memory Clinic Toride

Toride-shi, 302-0004, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Oita University Hospital

Yufu-shi, 879-5593, Japan

Location

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

LY3154207

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: August 26, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (44); JP (20)