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Trial record 3 of 3 for:    LY3303560

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

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE April 30, 2018
Estimated Primary Completion Date August 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 104 weeks ]
Change from baseline on the iADRS.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 80 weeks ]
Change from baseline on the iADRS.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
  • 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.
  • 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.
  • 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.
  • Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 104 weeks ]
    Change from baseline on the MMSE score.
  • Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 104 weeks ]
    Change from baseline in aggregated tau deposition.
  • 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.
  • 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.
  • Number of Participants with Treatment Emergent Anti-LY3303560 Antibodies [ Time Frame: Baseline through Week 113 ]
    Number of participants with treatment emergent anti-LY3303560 antibodies
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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.
  • 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.
  • 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.
  • Change from Baseline on the CogState Brief Battery (CBB) [ Time Frame: Baseline, 80 weeks ]
    Change from baseline on the CBB.
  • Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 80 weeks ]
    Change from baseline on the MMSE score.
  • Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 80 weeks ]
    Change from baseline in aggregated tau deposition.
  • 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.
  • 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.
  • Number of Participants with Treatment Emergent Anti-LY3303560 Antibodies [ Time Frame: Baseline through Week 128 ]
    Number of participants with treatment emergent anti-LY3303560 antibodies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Official Title  ICMJE Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease (AD)
Intervention  ICMJE
  • Drug: LY3303560
    Administered IV
  • Drug: Placebo
    Administered IV
Study Arms  ICMJE
  • Experimental: LY3303560 Dose 1
    LY3303560 administered intravenously (IV).
    Intervention: Drug: LY3303560
  • Experimental: LY3303560 Dose 2
    LY3303560 administered IV.
    Intervention: Drug: LY3303560
  • Placebo Comparator: Placebo
    Placebo administered IV.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
285
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 22, 2021
Estimated Primary Completion Date August 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03518073
Other Study ID Numbers  ICMJE 16124
I8G-MC-LMDC ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP