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

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Lanabecestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02972658

2016-003440-36 (EudraCT Number)

I8D-MC-AZFD (Other Identifier)

16557

Details and patient eligibility

About

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.

Full 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.

Enrollment: 421 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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421 participants in 4 patient groups

AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg

Experimental group

Description:

Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.

Treatment:

Drug: Lanabecestat

AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg

Experimental group

Description:

Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.

Treatment:

Drug: Lanabecestat

AZES Placebo/AZFD Lanabecestat 20 mg

Experimental group

Description:

Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.

Treatment:

Drug: Lanabecestat

AZES Placebo/AZFD Lanabecestat 50 mg

Experimental group

Description:

Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.

Treatment:

Drug: Lanabecestat