RECRUITING

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

Description

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.

Conditions

Alzheimer Disease
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Related Conditions:

Alzheimer Disease

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Phoenix

Banner Alzheimer's Institute, Phoenix, Arizona, United States, 85006

Little Rock

Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States, 72205

Carlsbad

Profound Research, LLC, Carlsbad, California, United States, 92011

Fresno

Neuro-Pain Medical Center, Fresno, California, United States, 93710

Montclair

Catalina Research Institute, LLC, Montclair, California, United States, 91763

Sherman Oaks

California Neuroscience Research Medical Group, Inc., Sherman Oaks, California, United States, 91403

Atlantis

JEM Research Institute, Atlantis, Florida, United States, 33462

Aventura

Visionary Investigators Network, Aventura, Florida, United States, 33180

Boca Raton

Excel Medical Clinical Trials, Boca Raton, Florida, United States, 33434

Clermont

Vertex Clinical Research, Clermont, Florida, United States, 34711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

50 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-01