A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Baptist Health Center for Clinical Research LLC
RECRUITING
Little Rock
Arizona
Banner Alzheimer's Institute
RECRUITING
Phoenix
California
Profound Research LLC At The Neurology Center of Southern California
RECRUITING
Carlsbad
Neuropain Medical Center
RECRUITING
Fresno
Catalina Research Institute
NOT_YET_RECRUITING
Montclair
California Neuroscience Research, LLC
RECRUITING
Sherman Oaks
Florida
JEM Research Institute
RECRUITING
Atlantis
Visionary Investigators Network
RECRUITING
Aventura
Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research
RECRUITING
Boca Raton
Vertex Clinical Research
ACTIVE_NOT_RECRUITING
Clermont
Neuropsychiatric Research Center of Southwest Florida
RECRUITING
Fort Myers
Clinical Neuroscience Solutions, Inc.
RECRUITING
Jacksonville
Merritt Island Medical Research, LLC dba Flourish Research
RECRUITING
Merritt Island
Visionary Investigators Network
RECRUITING
Miami
Suncoast Clinical Research - New Port Richey
RECRUITING
New Port Richey
Renstar Medical Research
RECRUITING
Ocala
Charter Research, LLC
RECRUITING
Orlando
Progressive Medical Research
RECRUITING
Port Orange
Intercoastal Medical Group
RECRUITING
Sarasota
Brain Matters Research
RECRUITING
Stuart
Charter Research - The Villages
RECRUITING
The Villages
Premiere Research Institute at Palm Beach Neurology
RECRUITING
West Palm Beach
Conquest Research
RECRUITING
Winter Park
Georgia
Accel Research Sites - NeuroStudies CRU
RECRUITING
Decatur
CenExel iResearch Atlanta
RECRUITING
Decatur
CenExel iResearch, LLC
RECRUITING
Savannah
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Illinois
Ascension Alexian Brothers
RECRUITING
Elk Grove Village
Indiana
Josephson, Wallack, Munshower Neurology, P.C.
RECRUITING
Indianapolis
Massachusetts
ActivMed Practices & Research, LLC
RECRUITING
Methuen
Michigan
QUEST Research Institute
RECRUITING
Farmington Hills
North Carolina
AMC Research, LLC dba Flourish Research
RECRUITING
Matthews
Eximia Clinical Research-NC, LLC
RECRUITING
Raleigh
New Jersey
CenExel Advanced Memory Research Institute of NJ
RECRUITING
Toms River
Pennsylvania
Keystone Clinical Studies, LLC Philadelphia dba Flourish Research
RECRUITING
Plymouth Meeting
Tennessee
Clinical Neuroscience Solutions, Inc.
RECRUITING
Memphis
Texas
Senior Adults Specialty Research
RECRUITING
Austin
Kerwin Medical Center
RECRUITING
Dallas
Cedar Health Research, LLC
RECRUITING
Euless
Clinical Trial Network LLC
RECRUITING
Houston
El Faro Health and Therapeutics
RECRUITING
Rio Grande City
Be Well Clinical Studies
RECRUITING
Round Rock
Clinical Trials of Texas, LLC San Antonio dba Flourish Research
NOT_YET_RECRUITING
San Antonio
Washington
University of Washington Medical Center
RECRUITING
Seattle
Other Locations
Japan
Akita City Hospital
RECRUITING
Akita
Memory Clinic Ochanomizu
RECRUITING
Bunkyō City
Inage Neurology and Memory Clinic
RECRUITING
Chiba
Ikuseikai Shinozuka Hospital
RECRUITING
Fujioka-shi
Kuramitsu Hospital
RECRUITING
Fukuoka
Mental Clinic Sakurazaka
RECRUITING
Fukuoka
Himeji Central Hospital Clinic
RECRUITING
Himeji-shi
Koseikai Cocoro Hospital Kusatsu
RECRUITING
Hiroshima
NHO Hizen Psychiatric Medical Center
RECRUITING
Kanzaki-gun
Rainbow & Sea Hospital
RECRUITING
Karatsu-shi
Kishikai Kishi Hospital
RECRUITING
Kiryu-shi
Southern TOHOKU Medical Clinic
RECRUITING
Koriyama-shi
Katayama Medical Clinic
RECRUITING
Kurashiki-shi
Mabashi Clinic
RECRUITING
Matsudo-shi
National Center for Geriatrics and Gerontology
RECRUITING
Obu-shi
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Tokyo Metropolitan Bokutoh Hospital
RECRUITING
Sumida-ku
Memory Clinic Toride
RECRUITING
Toride-shi
Yamagata University Hospital
RECRUITING
Yamagata
Oita University Hospital
RECRUITING
Yufu-shi
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-08-26
Estimated Completion Date: 2026-01
Participants
Target number of participants: 300
Treatments
Experimental: Mevidalen (high dose)
Mevidalen high dose administered orally.
Experimental: Mevidalen (low dose)
Mevidalen low dose administered orally.
Placebo_comparator: Placebo
Placebo administered orally.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company