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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. Identifier: NCT03518073
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : November 30, 2021
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)
Actual Enrollment : 360 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
Actual Primary Completion Date : August 23, 2021
Actual Study Completion Date : October 25, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT03518073

Show Show 60 study locations
Sponsors and Collaborators
Eli Lilly and Company
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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
Additional Information:
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Responsible Party: Eli Lilly and Company 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: November 30, 2021
Last Verified: November 2021
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

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through 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
Neurofibrillary tangles
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders