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Trial record 8 of 41 for:    lilly alzheimer

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02972658
First received: November 21, 2016
Last updated: May 11, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Alzheimer's Disease
Drug: Lanabecestat
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

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

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


Estimated Enrollment: 1400
Actual Study Start Date: March 15, 2017
Estimated Study Completion Date: July 1, 2020
Estimated Primary Completion Date: January 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02972658

  Show 142 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
  More Information

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 )
Study First Received: November 21, 2016
Last Updated: May 11, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 24, 2017