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

ID: NCT02972658
Status: Enrolling by invitation
Phase: Phase 3
Start Date: March 15, 2017
First Submitted: November 21, 2016
Last Updated: February 14, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company, AstraZeneca
Location: Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Romania, Spain, United Kingdom, United States
Conditions: 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Alzheimer's Disease

Drug: Lanabecestat
Other Names
LY3314814 AZD3293
Phase 3

Tracking Information

First Submitted DateNovember 21, 2016
Last Update Posted DateFebruary 14, 2018
Actual Start DateMarch 15, 2017
Anticipated Completion DateSeptember 30, 2021
Actual Primary Completion DateSeptember 30, 2021
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current 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

Original Primary Outcome Measures

Not Available

Current 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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
Official TitleA Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
1400
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Alzheimer's Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Lanabecestat

Administered orally

Other Names
LY3314814
AZD3293
Study Groups/Cohorts
Lanabecestat Dose 1
Lanabecestat given orally.

Lanabecestat Dose 2
Lanabecestat given orally.

AZES Placebo Arm / AZFD Dose 1
Lanabecestat given orally.

AZES Placebo Arm / AZFD Dose 2
Lanabecestat given orally.

Study Arms
Experimental AZES Placebo Arm / AZFD Dose 1
Lanabecestat given orally.
Drug : Lanabecestat
Administered orally

Experimental AZES Placebo Arm / AZFD Dose 2
Lanabecestat given orally.
Drug : Lanabecestat
Administered orally

Experimental Lanabecestat Dose 1
Lanabecestat given orally.
Drug : Lanabecestat
Administered orally

Experimental Lanabecestat Dose 2
Lanabecestat given orally.
Drug : Lanabecestat
Administered orally

Arm Intervention/Treatment
Experimental AZES Placebo Arm / AZFD Dose 1
Lanabecestat given orally.
Drug : Lanabecestat
Experimental AZES Placebo Arm / AZFD Dose 2
Lanabecestat given orally.
Drug : Lanabecestat
Experimental Lanabecestat Dose 1
Lanabecestat given orally.
Drug : Lanabecestat
Experimental Lanabecestat Dose 2
Lanabecestat given orally.
Drug : Lanabecestat

Recruitment Information

Recruitment Status:Enrolling by invitation
Enrollment1400
Completion DateSeptember 30, 2021
Eligibility 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.
GenderAll
Age55 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Australia
Belgium
Canada
France
Germany
Hungary
Italy
Japan
Korea, Republic of
Poland
Puerto Rico
Romania
Spain
United Kingdom
United States

Administrative Information

NCT Number:NCT02972658
Other Study ID Numbers
16557
I8D-MC-AZFD
2016-003440-36
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
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