I8D-MC-AZFD

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223641

Enrollment

1400

Registered

2017-09-05

Start date

2017-08-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Alzheimer's Disease Dementia

Interventions

investigational material(s) Generic name etc : LY3314814 INN of investigational material : Lanabecestat Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants previously enrolled in AMARANTH (JapicCTI-152905) who meet eligibility criteria for delayed start I8D-MC-AZFD.

Exclusion criteria

Exclusion criteria: Participants who participate in AMARANTH (JapicCTI-152905) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.

Design outcomes

Primary

Measure	Time frame
confirmatory The primary analysis of Study AZES-FD is to evaluate disease modification as outlined in Liu-Seifert (2015). This will be accomplished by testing the three delayed-start hypotheses in both doses of LY3314814 across Study AZES and up to Week 26 (Visit 7) of Study AZFD.	—

Secondary

Measure	Time frame
safety Collect information in order to further characterize the safety and tolerability of LY3314814 in patients with early AD dementia (at the time of entry into Study AZES) efficacy To evaluate the disease modification of both doses of LY3314814 on functional and cognitive outcomes across Study AZES and up to Week 26 (Visit 7) of Study AZFD using the primary analysis methodology.	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026