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Evaluating Mevidalen for Alzheimer's Disease Symptoms

A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease

Phase 2 Interventional Eli Lilly and Company · NCT06538116

This study is testing a new drug called mevidalen to see if it can help people with mild to moderate Alzheimer's disease feel better over about 26 weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages50 Years to 80 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations64 sites (Phoenix, Arizona and 63 other locations)
Trial IDNCT06538116 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of the drug mevidalen in individuals with mild to moderate Alzheimer's Disease. Participants will be monitored over approximately 26 weeks through up to 14 visits, assessing cognitive function, daily activities, sleep patterns, and overall symptoms of Alzheimer's. The study includes a placebo group for comparison, allowing researchers to evaluate the drug's impact on various aspects of the disease.

Who should consider this trial

Good fit: Ideal candidates are individuals with a gradual decline in memory function and a confirmed diagnosis of mild to moderate Alzheimer's Disease.

Not a fit: Patients with significant central nervous system or psychiatric diseases other than Alzheimer's may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from Alzheimer's Disease.

How similar studies have performed: Other studies have explored similar interventions for Alzheimer's Disease, but the specific approach with mevidalen is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.