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Mevidalen for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24

Summary

This trial aims to test the safety and effectiveness of a new drug called mevidalen in treating mild to moderate Alzheimer's Disease. Participants will be monitored for changes in memory, daily activities, sleep,

Who is the study for?
This trial is for individuals with mild to moderate Alzheimer's Disease dementia. Participants will be involved in the study for about 26 weeks and may need to attend up to 14 visits.
What is being tested?
The trial is testing Mevidalen, a new drug, against a placebo (a substance with no therapeutic effect) to see if it can improve cognition, daily activities, sleep quality, physical activity, and reduce irritability or anxiety in Alzheimer's patients.
What are the potential side effects?
While specific side effects are not listed here, common side effects of drugs like Mevidalen could include nausea, headache, dizziness or more serious ones depending on how the drug affects the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My memory has been getting worse for over 6 months, affecting my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart or liver issues, like high blood pressure or heart failure.
Select...
I am not taking any strong medications that affect liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
Secondary study objectives
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change score (ADCS-CGIC)
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)
Change from Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Mevidalen (low dose)Experimental Treatment1 Intervention
Mevidalen low dose administered orally.
Group II: Mevidalen (high dose)Experimental Treatment1 Intervention
Mevidalen high dose administered orally.
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered orally.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,670 Previous Clinical Trials
3,228,469 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,385 Previous Clinical Trials
426,091 Total Patients Enrolled
~200 spots leftby Dec 2025
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