Mevidalen for Alzheimer's Disease

Recruiting at61 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Childbearing potential, CNS disease, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use moderate or strong CYP3A4 inhibitors or inducers. It's best to discuss your medications with the trial team.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

Have MMSE score of 13 to 24

Have eligible 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

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.)

I have heart or liver issues, like high blood pressure or heart failure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mevidalen or placebo to evaluate efficacy and safety in Alzheimer's Disease

24 weeks

Up to 14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mevidalen (Other)

Trial Overview 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.

Participant Groups

Group I: Mevidalen (low dose) Experimental Treatment 1 Intervention

Mevidalen low dose administered orally.

Group II: Mevidalen (high dose) Experimental Treatment 1 Intervention

Mevidalen high dose administered orally.

Group III: Placebo Placebo Group 1 Intervention

Placebo administered orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University