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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: Lanabecestat Other Names LY3314814 AZD3293	Phase 3

Tracking Information

First Submitted Date	November 21, 2016
Last Update Posted Date	February 14, 2018
Actual Start Date	March 15, 2017
Anticipated Completion Date	September 30, 2021
Actual Primary Completion Date	September 30, 2021
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

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

Study Design

Brief Title	A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
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)
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 Type	Interventional
Study Phase	Phase 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 Method	N/A
Study Population	N/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 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

Recruitment Information

Recruitment Status:	Enrolling by invitation
Enrollment	1400
Completion Date	September 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.
Gender	All
Age	55 Years to N/A
Accepts Healthy Volunteers	No
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 Committee	Yes
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