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A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

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ClinicalTrials.gov Identifier: NCT02972658
Recruitment Status : Terminated (An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.)
First Posted : November 23, 2016
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Lanabecestat Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 2, 2018


Arm Intervention/treatment
Experimental: Lanabecestat Dose 1
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: Lanabecestat Dose 2
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: AZES Placebo Arm / AZFD Dose 1
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: AZES Placebo Arm / AZFD Dose 2
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293




Primary Outcome Measures :
  1. Delayed Start Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the ADAS-Cog13


Secondary Outcome Measures :
  1. Delayed Start Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the ADCS-iADL instrumental items

  2. Delayed Start Analysis on the Functional Activities Questionnaire (FAQ) Score [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the FAQ score

  3. Delayed Start Analysis on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the iADRS score

  4. Delayed Start Analysis on the Mini-Mental Status Examination (MMSE) [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the MMSE

  5. Delayed Start Analysis on the ADAS-Cog13 [ Time Frame: AZES Baseline through AZFD Week 52 ]
    Delayed start analysis on the ADAS-Cog13



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed start I8D-MC-AZFD.

Exclusion Criteria:

  • Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.

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): NCT02972658


  Show 133 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02972658     History of Changes
Other Study ID Numbers: 16557
I8D-MC-AZFD ( Other Identifier: Eli Lilly and Company )
2016-003440-36 ( EudraCT Number )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
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:
Alzheimer's Disease
Dementia
Brain Diseases
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies
Memory
Amyloid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders