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A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03518073
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : January 3, 2019
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

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 : January 1, 2021
Estimated Study Completion Date : October 8, 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, 80 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, 80 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, 80 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, 80 weeks ]
    Change from baseline on the CDR-SB score.

  4. Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 80 weeks ]
    Change from baseline on the MMSE score.

  5. Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 80 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, 80 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 80 ]
    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 128 ]
    Number of participants with treatment emergent anti-LY3303560 antibodies



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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


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

  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact    602-829-9608      
Principal Investigator: William Burke         
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
Contact    520-320-2140      
Principal Investigator: Michael A Badruddoja         
United States, California
Pharmacology Research Institute Recruiting
Encino, California, United States, 91316
Contact    818-705-7451      
Principal Investigator: DANIEL E. GROSZ         
Fullerton Neurology and Headache Center Recruiting
Fullerton, California, United States, 92835
Contact    714-738-0800      
Principal Investigator: Jack H. Florin         
Irvine Clinical Research Center Recruiting
Irvine, California, United States, 92614
Contact    949-753-1663      
Principal Investigator: Elly R Lee         
Pharmacology Research Institute Recruiting
Los Alamitos, California, United States, 90720
Contact    714-827-3668      
Principal Investigator: David A Rosenberg         
National Research Institute Recruiting
Panorama City, California, United States, 91402
Contact    818-532-6880      
Principal Investigator: Parvin D Syal         
Anderson Clinical Research Recruiting
Redlands, California, United States, 92374
Contact    909-792-9007      
Principal Investigator: Donald L Anderson         
Pacific Research Network Inc Recruiting
San Diego, California, United States, 92103
Contact    619-294-4302      
Principal Investigator: Stephen Thein         
Univ of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact    415-476-6880      
Principal Investigator: Julio Rojas-Martinez         
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
Contact    714-542-3008      
Principal Investigator: John Duffy         
United States, Connecticut
New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
Contact    203-914-1903      
Principal Investigator: Peter J McAllister         
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Contact    561-968-2933      
Principal Investigator: Mark A Goldstein         
Julie B. Schwartzbard, MD, PA Recruiting
Aventura, Florida, United States, 33180
Contact    305-933-5993      
Principal Investigator: Julie Schwartzbard         
Quantum Laboratories Recruiting
Deerfield Beach, Florida, United States, 33064
Contact    954-786-7331      
Principal Investigator: Jose E De La Gandara         
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact    561-374-8461      
Principal Investigator: Mark Brody         
Neuropsychiatric Research Center of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33912
Contact    2399397777      
Principal Investigator: Wendy Robinson Bond         
Infinity Clinical Research, LLC Recruiting
Hollywood, Florida, United States, 33024
Contact    954-620-3340      
Principal Investigator: Harvey Schwartz         
VIN - Victor Faradji Recruiting
Miami, Florida, United States, 33176
Contact    305-595-4041      
Principal Investigator: Victor Faradji         
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34470
Contact    352-629-5800      
Principal Investigator: John P. Nardandrea         
BioClinica Inc Recruiting
Orlando, Florida, United States, 32806
Contact    407-210-1320      
Principal Investigator: Ira J Goodman         
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Contact    386-304-7070      
Principal Investigator: Alexander J White         
Brain Matters Research - Stuart Not yet recruiting
Stuart, Florida, United States, 34997
Contact    561-374-8461      
Principal Investigator: Mark Brody         
Infinity Clinical Research, LLC Recruiting
Sunrise, Florida, United States, 33351
Contact    9544758171      
Principal Investigator: Richard Pete Singer         
United States, Georgia
Medical Research Health and Education Foundation, Inc Recruiting
Columbus, Georgia, United States, 31909
Contact    706-653-8455      
Principal Investigator: Jonathan L Liss         
United States, Illinois
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Contact    773-275-3500      
Principal Investigator: Jeffrey S. Ross         
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact    847-981-3630      
Principal Investigator: Ajay Sood         
United States, Indiana
Josephson Wallack Munshower Neurology Recruiting
Indianapolis, Indiana, United States, 46256
Contact    317-537-6056      
Principal Investigator: Kristi George         
United States, Kansas
Rowe Neurology Institute Recruiting
Lenexa, Kansas, United States, 66214
Contact    913-894-1500      
Principal Investigator: Vernon Rowe         
Cotton O'Neil Clinic Recruiting
Topeka, Kansas, United States, 66606
Contact    785-354-3680      
Principal Investigator: Michael Cox         
United States, Maryland
PharmaSite Research Inc Recruiting
Baltimore, Maryland, United States, 21208
Contact    410-602-1440      
Principal Investigator: Alan M. Jonas         
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact    617-636-5000      
Principal Investigator: Tinatin Chabrashvili         
Boston Center for Memory Recruiting
Newton, Massachusetts, United States, 02459
Contact    617-699-6927      
Principal Investigator: Paul R. Solomon         
United States, Missouri
Clinical Research Professionals Recruiting
Saint Louis, Missouri, United States, 63141
Contact    636-220-1200      
Principal Investigator: Siddharth Kaul         
United States, New Jersey
Princeton Medical Institute Not yet recruiting
Princeton, New Jersey, United States, 08540
Contact    609-921-3555      
Principal Investigator: Jeffrey T Apter         
The Cognitive and Research Center of NJ Recruiting
Springfield, New Jersey, United States, 07081
Contact    973-850-4622      
Principal Investigator: Michelle Papka         
Advanced Memory Research Institute of New Jersey Recruiting
Toms River, New Jersey, United States, 08755
Contact    732-341-9500      
Principal Investigator: Sanjiv K Sharma         
United States, North Carolina
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607
Contact    919-782-3456      
Principal Investigator: Bradley J Robottom         
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact    336-768-8062      
Principal Investigator: Franklin Giles Crowell         
United States, Ohio
Lindner Research Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact    513-585-1777      
Principal Investigator: Robert S Keyes         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact    614-293-4969      
Principal Investigator: Douglas W. Scharre         
University of Cincinnati Health Neurology Recruiting
Dayton, Ohio, United States, 45417
Contact    937-495-0000      
Principal Investigator: Lawrence P Goldstick         
United States, Pennsylvania
Lehigh Center for Clinical Research Recruiting
Allentown, Pennsylvania, United States, 18104
Contact    610-820-0342      
Principal Investigator: Paul K. Gross         
Suburban Research Associates Recruiting
Media, Pennsylvania, United States, 19063
Contact    610-891-9024      
Principal Investigator: Shivkumar Hatti         
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-455-6403      
Principal Investigator: Stephen P Salloway         
United States, Texas
Baylor AT&T Memory Center Recruiting
Dallas, Texas, United States, 75231
Contact    214-820-7665      
Principal Investigator: Claudia Padilla         
Neurology Consultants of Dallas, PA Recruiting
Dallas, Texas, United States, 75231
Contact    214-750-9977      
Principal Investigator: Duc Tran         
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact    713-441-1150      
Principal Investigator: Joseph C Masdeu         
United States, Vermont
The Memory Clinic Recruiting
Bennington, Vermont, United States, 05201
Contact    802-447-1409      
Principal Investigator: Diana Michalczuk         
United States, Virginia
Cognition Health Recruiting
Fairfax, Virginia, United States, 22031
Contact    703-505-8276      
Principal Investigator: James L Bicksel         
Canada, Ontario
Kawartha Regional Memory Clinic Recruiting
Peterborough, Ontario, Canada, K9H2P4
Contact    7057493906      
Principal Investigator: Jennifer Ingram         
Toronto Memory Program Recruiting
Toronto, Ontario, Canada, M3B2S7
Contact    4163869761      
Principal Investigator: C. Ian Cohen         
Canada, Quebec
Clinique de la Memoire de l'Outaouais Recruiting
Gatineau, Quebec, Canada, J8T 8J1
Contact    8197768027      
Principal Investigator: Richard Bergeron         
NeuroSearch Developements Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Contact    4506727766      
Principal Investigator: Ziad Nasreddine         
Q&T Research Sherbrooke Inc Recruiting
Sherbrooke, Quebec, Canada, J1J 2G2
Contact    8195626374      
Principal Investigator: Paule Royer         
Japan
National Center for Geriatrics and Gerontology Recruiting
Obu City, Aichi, Japan, 4748511
Contact    81120360605      
Principal Investigator: Masashi Tsujimoto         
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan, 650-0046
Contact    81120360605      
Principal Investigator: Kunitaka Matsuishi         
Shonan Kamakura General Hospital Recruiting
Kamakura, Kanagawa, Japan, 247-8533
Contact    81120360605      
Principal Investigator: Junya Kawada         
Katayama Medical Clinic Recruiting
Kurashiki, Okayama, Japan, 701-0192
Contact    81120360605      
Principal Investigator: Sadao Katayama         
Nippon Medical School Hospital Recruiting
Bunkyo-Ku, Tokyo, Japan, 113 8603
Contact    81120360605      
Principal Investigator: Yoshiro Okubo         
Utano Hospital Recruiting
Kyoto, Japan, 616-8255
Contact    81120360605      
Principal Investigator: Shinji Sudoh         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03518073     History of Changes
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: January 3, 2019
Last Verified: January 1, 2019
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.


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:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders