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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06538116

Run by

Eli Lilly and Company

People needed

304

Starts

2024-08-26

Expected to finish

2026-05-11

Last updated by the study team

2026-06-18

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Banner Alzheimer's Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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