A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
NCT ID: NCT03518073
Last Updated: 2022-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2018-04-30
2021-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks.
Placebo
Administered IV
Zagotenemab 1400 mg
Participants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks.
Zagotenemab
Administered IV
Zagotenemab 5600 mg
Participants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks.
Zagotenemab
Administered IV
Interventions
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Zagotenemab
Administered IV
Placebo
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.
Exclusion Criteria
* Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy \<24 months.
* Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.
* Participants must not have serious risk for suicide.
* Participants must not have history of drug or alcohol use disorder within the last 2 years.
* Participants must not have multiple severe drug allergies
* Participants must not have HIV, Hepatitis B or Hepatitis C
* Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy
60 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Pharmacology Research Institute
Encino, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Irvine Clinical Research Center
Irvine, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
National Research Institute - Huntington Park
Panorama City, California, United States
Anderson Clinical Research
Redlands, California, United States
Pacific Research Network
San Diego, California, United States
Univ of California San Francisco
San Francisco, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Julie B. Schwartzbard, MD, PA
Aventura, Florida, United States
Quantum Laboratories Clinical Research
Deerfield Beach, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
VIN-Victor Faradji
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
BioClinica Inc
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Columbus Memory Center, PC
Columbus, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Lindner Research Center
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Cincinnati Health Neurology
Dayton, Ohio, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Butler Hospital
Providence, Rhode Island, United States
Baylor AT&T Memory Center
Dallas, Texas, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, United States
Houston Methodist Research Ins
Houston, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
Cognition Health
Fairfax, Virginia, United States
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ca-on, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Clinique de la Mémoire de l'Outaouais
Gatineau, Quebec, Canada
NeuroSearch Developements
Greenfield Park, Quebec, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Nippon Medical School Hospital
Tokyo, Jp-13, Japan
National hospital Organization Utano National Hospital
Kyoto, Jp-26, Japan
Katayama Medical Clinic
Kurashiki, Jp-33, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Countries
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References
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Fleisher AS, Munsie LM, Perahia DGS, Andersen SW, Higgins IA, Hauck PM, Lo AC, Sims JR, Brys M, Mintun M; PERISCOPE-ALZ Site Investigators. Assessment of Efficacy and Safety of Zagotenemab: Results From PERISCOPE-ALZ, a Phase 2 Study in Early Symptomatic Alzheimer Disease. Neurology. 2024 Mar 12;102(5):e208061. doi: 10.1212/WNL.0000000000208061. Epub 2024 Feb 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Other Identifiers
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I8G-MC-LMDC
Identifier Type: OTHER
Identifier Source: secondary_id
16124
Identifier Type: -
Identifier Source: org_study_id
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