A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease
NCT ID: NCT06538116
Last Updated: 2025-11-06
Study Results
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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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2024-08-26
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mevidalen (high dose)
Mevidalen high dose administered orally.
Mevidalen
Administered orally
Mevidalen (low dose)
Mevidalen low dose administered orally.
Mevidalen
Administered orally
Placebo
Placebo administered orally.
Placebo
Administered orally
Interventions
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Mevidalen
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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
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
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Merritt Island Medical Research, LLC dba Flourish Research
Merritt Island, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Suncoast Clinical Research - New Port Richey
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charter Research, LLC
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Charter Research - The Villages
The Villages, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Accel Research Sites - NeuroStudies CRU
Decatur, Georgia, United States
CenExel iResearch Atlanta
Decatur, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
Josephson, Wallack, Munshower Neurology, P.C.
Indianapolis, Indiana, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
CenExel Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
AMC Research, LLC dba Flourish Research
Matthews, North Carolina, United States
Eximia Clinical Research-NC, LLC
Raleigh, North Carolina, United States
Keystone Clinical Studies, LLC Philadelphia dba Flourish Research
Plymouth Meeting, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.Ta
Memphis, Tennessee, United States
Senior Adults Specialty Research
Austin, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
Cedar Health Research, LLC
Euless, Texas, United States
Clinical Trial Network LLC
Houston, Texas, United States
El Faro Health and Therapeutics
Rio Grande City, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Clinical Trials of Texas, LLC San Antonio dba Flourish Research
San Antonio, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Akita City Hospital
Akita, , Japan
Memory Clinic Ochanomizu
Bunkyō City, , Japan
Inage Neurology and Memory Clinic
Chiba, , Japan
Ikuseikai Shinozuka Hospital
Fujioka-shi, , Japan
Mental Clinic Sakurazaka
Fukuoka, , Japan
Kuramitsu Hospital
Fukuoka, , Japan
Himeji Central Hospital Clinic
Himeji-shi, , Japan
Koseikai Cocoro Hospital Kusatsu
Hiroshima, , Japan
NHO Hizen Psychiatric Medical Center
Kanzaki-gun, , Japan
Rainbow & Sea Hospital
Karatsu-shi, , Japan
Kishikai Kishi Hospital
Kiryu-shi, , Japan
Southern TOHOKU Medical Clinic
Koriyama-shi, , Japan
Katayama Medical Clinic
Kurashiki-shi, , Japan
Mabashi Clinic
Matsudo-shi, , Japan
National Center for Geriatrics and Gerontology
Obu-shi, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, , Japan
Memory Clinic Toride
Toride-shi, , Japan
Yamagata University Hospital
Yamagata, , Japan
Oita University Hospital
Yufu-shi, , Japan
Countries
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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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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