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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 : Recruiting
First Posted : November 23, 2016
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

November 21, 2016
November 23, 2016
September 21, 2018
March 15, 2017
October 1, 2018   (Final data collection date for primary outcome measure)
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
Delayed Start Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: AZES Baseline through AZFD Week 26 ]
Complete list of historical versions of study NCT02972658 on ClinicalTrials.gov Archive Site
  • 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
  • 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 Functional Activities Questionnaire (FAQ) Score [ Time Frame: AZES Baseline through AZFD Week 26 ]
  • 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 Mini-Mental Status Examination (MMSE) [ Time Frame: AZES Baseline through AZFD Week 26 ]
  • Delayed Start Analysis on the ADAS-Cog13 [ Time Frame: AZES Baseline through AZFD Week 52 ]
Not Provided
Not Provided
 
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293
  • Experimental: Lanabecestat Dose 1
    Lanabecestat given orally.
    Intervention: Drug: Lanabecestat
  • Experimental: Lanabecestat Dose 2
    Lanabecestat given orally.
    Intervention: Drug: Lanabecestat
  • Experimental: AZES Placebo Arm / AZFD Dose 1
    Lanabecestat given orally.
    Intervention: Drug: Lanabecestat
  • Experimental: AZES Placebo Arm / AZFD Dose 2
    Lanabecestat given orally.
    Intervention: Drug: Lanabecestat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
Same as current
October 1, 2018
October 1, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Australia,   Belgium,   Canada,   France,   Germany,   Hungary,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Romania,   Spain,   United Kingdom,   United States
Italy
 
NCT02972658
16557
I8D-MC-AZFD ( Other Identifier: Eli Lilly and Company )
2016-003440-36 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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.

Eli Lilly and Company
Eli Lilly and Company
AstraZeneca
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
Eli Lilly and Company
September 17, 2018

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