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Trial record 1 of 1 for:    LMDC | Alzheimer Disease
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A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518073
Recruitment Status : Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease (AD) Drug: LY3303560 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : August 23, 2021
Estimated Study Completion Date : October 22, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3303560 Dose 1
LY3303560 administered intravenously (IV).
Drug: LY3303560
Administered IV

Experimental: LY3303560 Dose 2
LY3303560 administered IV.
Drug: LY3303560
Administered IV

Placebo Comparator: Placebo
Placebo administered IV.
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 104 weeks ]
    Change from baseline on the iADRS.


Secondary Outcome Measures :
  1. Change from Baseline on the Alzheimer's Disease Assessment Scale—Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, 104 weeks ]
    Change from baseline on the ADAS—Cog13 score.

  2. Change from Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score [ Time Frame: Baseline, 104 weeks ]
    Change from baseline on the ADCS-iADL score.

  3. Change from Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, 104 weeks ]
    Change from baseline on the CDR-SB score.

  4. Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 104 weeks ]
    Change from baseline on the MMSE score.

  5. Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 104 weeks ]
    Change from baseline in aggregated tau deposition.

  6. Change from Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 104 weeks ]
    Change from baseline in brain volume as measured by vMRI.

  7. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through Week 104 ]
    Percentage of participants with suicidal ideation and behaviors assessed by the C-SSRS.

  8. Number of Participants with Treatment Emergent Anti-LY3303560 Antibodies [ Time Frame: Baseline through Week 113 ]
    Number of participants with treatment emergent anti-LY3303560 antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518073


Locations
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United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
Fullerton Neurology and Headache Center
Fullerton, California, United States, 92835
Irvine Clinical Research Center
Irvine, California, United States, 92614
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
National Research Institute
Panorama City, California, United States, 91402
Anderson Clinical Research
Redlands, California, United States, 92374
Pacific Research Network Inc
San Diego, California, United States, 92103
Univ of California San Francisco
San Francisco, California, United States, 94158
Syrentis Clinical Research
Santa Ana, California, United States, 92705
United States, Connecticut
New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Julie B. Schwartzbard, MD, PA
Aventura, Florida, United States, 33180
Quantum Laboratories
Deerfield Beach, Florida, United States, 33064
Brain Matters Research
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Infinity Clinical Research, LLC
Hollywood, Florida, United States, 33024
VIN - Victor Faradji
Miami, Florida, United States, 33176
Renstar Medical Research
Ocala, Florida, United States, 34470
BioClinica Inc
Orlando, Florida, United States, 32806
Progressive Medical Research
Port Orange, Florida, United States, 32127
Brain Matters Research - Stuart
Stuart, Florida, United States, 34997
Infinity Clinical Research, LLC
Sunrise, Florida, United States, 33351
United States, Georgia
Medical Research Health and Education Foundation, Inc
Columbus, Georgia, United States, 31909
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States, 46256
United States, Kansas
Rowe Neurology Institute
Lenexa, Kansas, United States, 66214
Cotton O'Neil Clinic
Topeka, Kansas, United States, 66606
United States, Maryland
PharmaSite Research Inc
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Boston Center for Memory
Newton, Massachusetts, United States, 02459
United States, Missouri
Clinical Research Professionals
Chesterfield, Missouri, United States, 63005
United States, New Jersey
The Cognitive and Research Center of NJ
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States, 08755
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Lindner Research Center
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
University of Cincinnati Health Neurology
Dayton, Ohio, United States, 45417
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Suburban Research Associates
Media, Pennsylvania, United States, 19063
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Baylor AT&T Memory Center
Dallas, Texas, United States, 75231
Neurology Consultants of Dallas, PA
Dallas, Texas, United States, 75231
Houston Methodist
Houston, Texas, United States, 77030
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
Cognition Health
Fairfax, Virginia, United States, 22031
Canada, Ontario
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H2P4
Toronto Memory Program
Toronto, Ontario, Canada, M3B2S7
Canada, Quebec
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada, J8T 8J1
NeuroSearch Developements
Greenfield Park, Quebec, Canada, J4V 2J2
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, Canada, J1J 2G2
Japan
National Center for Geriatrics and Gerontology
Obu City, Aichi, Japan, 4748511
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0046
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 247-8533
Katayama Medical Clinic
Kurashiki, Okayama, Japan, 701-0192
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, Japan, 113 8603
Utano Hospital
Kyoto, Japan, 616-8255
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03518073    
Other Study ID Numbers: 16124
I8G-MC-LMDC ( Other Identifier: Eli Lilly and Company )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Memory problems
Cognitive impairment
PERISCOPE-ALZ
Dementia
Tauopathy
Neurofibrillary tangles
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders