RECRUITING

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

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Conditions

Alzheimer Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-26
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538116

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.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Have MMSE score of 13 to 24.
  3. * Have eligibile plasma P-tau or historical evidence of AD pathology.
  4. * 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.
  5. * Males with partners of childbearing potential must agree to abide with provided contraception guidance.
  1. * Are individuals of childbearing potential.
  2. * 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.,).
  3. * Have cardiovascular-related risk factors or history that include uncontrolled hypertension, heart failure, stroke; or liver-related abnormalities.
  4. * Use of moderate or strong CYP3A4 inhibitors or inducers.
  5. * Have participated within the last 30 days in a clinical trial involving an investigational product.
  6. * Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

Banner Alzheimer's Institute
Phoenix, Arizona, 85006
United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
United States
Profound Research, LLC
Carlsbad, California, 92011
United States
Neuro-Pain Medical Center
Fresno, California, 93710
United States
Catalina Research Institute, LLC
Montclair, California, 91763
United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
United States
JEM Research Institute
Atlantis, Florida, 33462
United States
Visionary Investigators Network
Aventura, Florida, 33180
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Vertex Clinical Research
Clermont, Florida, 34711
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
United States
Visionary Investigators Network
Miami, Florida, 33176
United States
Suncoast Clinical Research
New Port Richey, Florida, 34652
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Charter Research
Orlando, Florida, 32803
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
Intercoastal Medical Group - Hyde Park
Sarasota, Florida, 34239
United States
Brain Matters Research
Stuart, Florida, 34997
United States
Charter Research, LLC
The Villages, Florida, 32162
United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
United States
Conquest Clinical Research, LLC
Winter Park, Florida, 32789
United States
NeuroStudies
Decatur, Georgia, 30030
United States
CenExel iResearch, LLC
Savannah, Georgia, 31405
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844
United States
QUEST Research Institute
Farmington Hills, Michigan, 49334
United States
CenExel Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755
United States
AMC Research
Matthews, North Carolina, 28105
United States
Eximia Research-NC, LLC
Raleigh, North Carolina, 27607
United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119
United States
Cedar Health Research LLC
Arlington, Texas, 76040
United States
Senior Adults Specialty Research
Austin, Texas, 78757
United States
Clinical Trial Network
Houston, Texas, 77074
United States
El Faro Health and Therapeutics
Rio Grande City, Texas, 78582
United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-08-26
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease