A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease
2 other identifiers
interventional
360
3 countries
60
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2018
Typical duration for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2018
CompletedStudy Start
First participant enrolled
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2021
CompletedResults Posted
Study results publicly available
August 30, 2022
CompletedAugust 30, 2022
August 1, 2022
3.3 years
April 26, 2018
August 12, 2022
August 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Integrated Alzheimer's Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval.
Baseline, Week 104
Secondary Outcomes (8)
Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score
Baseline, Week 104
Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
Baseline, Week 104
Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
Baseline, Week 104
Change From Baseline on the Mini Mental Status Examination (MMSE) Score
Baseline, Week 104
Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan.
Baseline, Week 104
- +3 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks.
Zagotenemab 1400 mg
EXPERIMENTALParticipants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks.
Zagotenemab 5600 mg
EXPERIMENTALParticipants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have gradual and progressive change in memory function for \>6 months.
- Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.
You may not qualify if:
- Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
Irvine Clinical Research Center
Irvine, California, 92614, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
National Research Institute - Huntington Park
Panorama City, California, 91402, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Pacific Research Network
San Diego, California, 92103, United States
Univ of California San Francisco
San Francisco, California, 94158, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Julie B. Schwartzbard, MD, PA
Aventura, Florida, 33180, United States
Quantum Laboratories Clinical Research
Deerfield Beach, Florida, 33064, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
VIN-Victor Faradji
Miami, Florida, 33176, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
BioClinica Inc
Orlando, Florida, 32806, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Brain Matters Research
Stuart, Florida, 34997, United States
Infinity Clinical Research, LLC
Sunrise, Florida, 33351, United States
Columbus Memory Center, PC
Columbus, Georgia, 31909, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, 60007, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Lindner Research Center
Cincinnati, Ohio, 45219, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Cincinnati Health Neurology
Dayton, Ohio, 45417, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Baylor AT&T Memory Center
Dallas, Texas, 75231, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243, United States
Houston Methodist Research Ins
Houston, Texas, 77030, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Cognition Health
Fairfax, Virginia, 22031, United States
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ca-on, K9H 2P4, Canada
Toronto Memory Program
Toronto, Ontario, M3B2S7, Canada
Clinique de la Mémoire de l'Outaouais
Gatineau, Quebec, J8T 8J1, Canada
NeuroSearch Developements
Greenfield Park, Quebec, J4V 2J2, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1J 2G2, Canada
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, 4748511, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0046, Japan
Nippon Medical School Hospital
Tokyo, Jp-13, 113-8603, Japan
National hospital Organization Utano National Hospital
Kyoto, Jp-26, 616-8255, Japan
Katayama Medical Clinic
Kurashiki, Jp-33, 710-0813, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
Related Publications (1)
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.
PMID: 38386949DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2018
First Posted
May 8, 2018
Study Start
April 30, 2018
Primary Completion
August 23, 2021
Study Completion
October 25, 2021
Last Updated
August 30, 2022
Results First Posted
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.