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NCT06538116CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
304 (actual)
First submitted
1 Aug 2024
Start date
26 Aug 2024
Primary completion date
1 May 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT06538116

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 304
  • From 26 Aug 2024 to the primary completion date, 1 May 2026
  • 64 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of moderate or strong CYP3A4 inhibitors or inducers.
  • Have participated within the last 30 days in a clinical trial involving an investigational product.

Other illness

  • 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.

Other

  • Are individuals of childbearing potential.
  • Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

Who the study is looking for

  • 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.

Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akita City Hospital
Coordinator of this site? Confirm its status
AkitaJapanUnknown status
Memory Clinic Ochanomizu
Coordinator of this site? Confirm its status
Bunkyō CityJapanUnknown status
Inage Neurology and Memory Clinic
Coordinator of this site? Confirm its status
ChibaJapanUnknown status
Ikuseikai Shinozuka Hospital
Coordinator of this site? Confirm its status
Fujioka-shiJapanUnknown status
Mental Clinic Sakurazaka
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Kuramitsu Hospital
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Himeji Central Hospital Clinic
Coordinator of this site? Confirm its status
Himeji-shiJapanUnknown status
Koseikai Cocoro Hospital Kusatsu
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
NHO Hizen Psychiatric Medical Center
Coordinator of this site? Confirm its status
Kanzaki-gunJapanUnknown status
Rainbow & Sea Hospital
Coordinator of this site? Confirm its status
Karatsu-shiJapanUnknown status
Kishikai Kishi Hospital
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Kiryu-shiJapanUnknown status
Southern TOHOKU Medical Clinic
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Koriyama-shiJapanUnknown status
Katayama Medical Clinic
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Kurashiki-shiJapanUnknown status
Mabashi Clinic
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Matsudo-shiJapanUnknown status
National Center for Geriatrics and Gerontology
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Obu-shiJapanUnknown status
Tokyo Medical University Hospital
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Shinjuku-kuJapanUnknown status
Tokyo Metropolitan Bokutoh Hospital
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Sumida-kuJapanUnknown status
Memory clinic Toride
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Toride-shiJapanUnknown status
Yamagata University Hospital
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YamagataJapanUnknown status
Oita University Hospital
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Yufu-shiJapanUnknown status
JEM Research Institute
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AtlantisUnited StatesUnknown status
Senior Adults Specialty Research
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Visionary Investigators Network
Coordinator of this site? Confirm its status
AventuraUnited StatesUnknown status
Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research
Coordinator of this site? Confirm its status
Boca RatonUnited StatesUnknown status
Profound Research LLC at The Neurology Center of Southern California
Coordinator of this site? Confirm its status
CarlsbadUnited StatesUnknown status
Vertex Clinical Research
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ClermontUnited StatesUnknown status
Kerwin Medical Center
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DallasUnited StatesUnknown status
Accel Research Sites - NeuroStudies CRU
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DecaturUnited StatesUnknown status
CenExel - iResearch Atlanta
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DecaturUnited StatesUnknown status
Ascension Alexian Brothers
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Elk Grove VillageUnited StatesUnknown status
Cedar Health Research, LLC
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EulessUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Neuropsychiatric Research Center of Southwest Florida
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Fort MyersUnited StatesUnknown status
Neuropain Medical Center
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FresnoUnited StatesUnknown status
Hawaii Pacific Neuroscience
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HonoluluUnited StatesUnknown status
Clinical Trial Network LLC
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HoustonUnited StatesUnknown status
Josephson Wallack Munshower Neurology P.C.
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IndianapolisUnited StatesUnknown status
Clinical NeuroScience Solutions Inc
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JacksonvilleUnited StatesUnknown status
Baptist Health Center for Clinical Research LLC
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Little RockUnited StatesUnknown status
AMC Research LLC, dba Flourish Research
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MatthewsUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.Ta
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Merritt Island Medical Research, LLC dba Flourish Research
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Merritt IslandUnited StatesUnknown status
ActivMed Practices & Research, LLC
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MethuenUnited StatesUnknown status
Visionary Investigators Network
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MiamiUnited StatesUnknown status
Catalina Research Institute
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MontclairUnited StatesUnknown status
Suncoast Clinical Research - New Port Richey
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New Port RicheyUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Charter Research, LLC
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OrlandoUnited StatesUnknown status
Banner Alzheimer's Institute
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Keystone Clinical Studies, LLC Philadelphia dba Flourish Research
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Plymouth MeetingUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Eximia Clinical Research-NC, LLC
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RaleighUnited StatesUnknown status
El Faro Health and Therapeutics
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Rio Grande CityUnited StatesUnknown status
Be Well Clinical Studies
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Round RockUnited StatesUnknown status
Clinical Trials of Texas, LLC San Antonio dba Flourish Research
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San AntonioUnited StatesUnknown status
Intercoastal Medical Group
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SarasotaUnited StatesUnknown status
CenExel iResearch, LLC
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SavannahUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
California Neuroscience Research, LLC
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Sherman OaksUnited StatesUnknown status
Brain Matters Research
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StuartUnited StatesUnknown status
Charter Research The Villages
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The VillagesUnited StatesUnknown status
CenExel - Advanced Memory Research Institute of NJ
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Toms RiverUnited StatesUnknown status
Premiere Research Institute at Palm Beach Neurology
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesUnknown status
Conquest Research
Coordinator of this site? Confirm its status
Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.