Trials / Terminated
TerminatedNCT02972658
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)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 421 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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 AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants originally randomized to receive placebo in the double-blind feeder study AZES and switched to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants originally randomized to receive LY3314814 in the double-blind feeder study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lanabecestat | Administered orally |
Timeline
- Start date
- 2017-03-15
- Primary completion
- 2018-10-02
- Completion
- 2018-10-02
- First posted
- 2016-11-23
- Last updated
- 2019-12-03
- Results posted
- 2019-07-05
Locations
133 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Japan, Poland, Puerto Rico, Romania, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02972658. Inclusion in this directory is not an endorsement.