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

Launched by ELI LILLY AND COMPANY · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called mevidalen (LY3154207) to see if it is safe and effective for people with mild to moderate Alzheimer's disease. The goal is to find out if this drug can help improve thinking, memory, daily activities, sleep, and reduce symptoms like irritability and anxiety over a period of about 26 weeks. Participants will have up to 14 visits during the study to monitor their progress.

To be eligible for this trial, participants need to have experienced a decline in memory and thinking skills for at least six months, affecting their daily life. They should also have a specific score on a cognitive test and have a reliable partner who can help support them during the study. However, individuals with certain other medical conditions, recent participation in other trials, or significant risks for suicide cannot take part in this study. Overall, this trial aims to explore new treatment options for Alzheimer’s disease and understanding its effects on daily living.

Gender

ALL

Eligibility criteria

• 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.