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Trial record 1 of 1 for:    NCT03518073
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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 : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 Design
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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 : January 1, 2021
Estimated Study Completion Date : October 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
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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

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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
More Information
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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: April 3, 2019
Last Verified: April 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.

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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