Status:
ACTIVE_NOT_RECRUITING
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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) dementi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06538116
Start Date
August 26 2024
End Date
May 1 2026
Last Update
December 17 2025
Active Locations (64)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
Baptist Health Center for Clinical Research LLC
Little Rock, Arkansas, United States, 72205
3
Profound Research LLC At The Neurology Center of Southern California
Carlsbad, California, United States, 92011
4
Neuropain Medical Center
Fresno, California, United States, 93710