TerminatedPhase 3Results posted

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)

Lead sponsor

AstraZeneca

Asset

Lanabecestat

Listed sites

133

Recruiting sites

Enrollment

421

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥55

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID16557

Eudract number2016-003440-36

Secondary IDI8D-MC-AZFDEli Lilly and Company

NCT IDNCT02972658

Timeline

Milestones

Study first posted2016-11-23estimated

Study start2017-03-15actual

Primary completion2018-10-02actual

Study completion2018-10-02actual

Results first posted2019-07-05actual

Last update posted2019-12-03actual

Assets

Drug assets

Lanabecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Other (unclassified)

Global cognition

6 endpoints

Primary/protocol endpoint

Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

Time frame:AZES Baseline through AZFD Week 26

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

Time frame:AZES Baseline through AZFD Week 26

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
AZES Placebo/AZFD Lanabecestat 20 mgn=76 Participants	9.61	1.60
AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mgn=139 Participants	9.25	1.21
AZES Placebo/AZFD Lanabecestat 50 mgn=75 Participants	8.41	1.65
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgn=131 Participants	10.41	1.25

Secondary/protocol endpoint

Change From Baseline on the Mini-Mental Status Examination (MMSE)

Time frame:AZES Baseline through AZFD Week 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Analysis on the ADAS-Cog13

Time frame:AZES Baseline through AZFD Week 52

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Mini-Mental Status Examination (MMSE)

Time frame:AZES Baseline through AZFD Week 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
AZES Placebo/AZFD Lanabecestat 20 mgn=76 Participants	-5.84	0.71
AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mgn=139 Participants	-5.73	0.54
AZES Placebo/AZFD Lanabecestat 50 mgn=75 Participants	-4.72	0.72
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgn=131 Participants	-5.25	0.56

Secondary/registry result

Change From Baseline Analysis on the ADAS-Cog13

Time frame:AZES Baseline through AZFD Week 52

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
AZES Placebo/AZFD Lanabecestat 20 mgn=76 Participants	16.64	3.45
AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mgn=139 Participants	12.40	2.25
AZES Placebo/AZFD Lanabecestat 50 mgn=75 Participants	16.79	2.47
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgn=131 Participants	15.05	2.06

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)

Time frame:AZES Baseline through AZFD Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Functional Activities Questionnaire (FAQ) Score

Time frame:AZES Baseline through AZFD Week 26

change from baseline, improvement

Secondary/registry result

Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)

Time frame:AZES Baseline through AZFD Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
AZES Placebo/AZFD Lanabecestat 20 mgn=76 Participants	-9.19	1.47
AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mgn=139 Participants	-8.45	1.10
AZES Placebo/AZFD Lanabecestat 50 mgn=74 Participants	-7.37	1.51
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgn=129 Participants	-7.48	1.14

Secondary/registry result

Change From Baseline on the Functional Activities Questionnaire (FAQ) Score

Time frame:AZES Baseline through AZFD Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
AZES Placebo/AZFD Lanabecestat 20 mgn=76 Participants	6.28	0.98
AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mgn=137 Participants	7.09	0.76
AZES Placebo/AZFD Lanabecestat 50 mgn=74 Participants	6.73	1.01
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgn=130 Participants	6.91	0.79

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Time frame:AZES Baseline through AZFD Week 26

ADAS-Cog

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Time frame:AZES Baseline through AZFD Week 26

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
AZES Placebo/AZFD Lanabecestat 20 mgn=76 Participants	-18.85	2.58
AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mgn=138 Participants	-17.57	1.97
AZES Placebo/AZFD Lanabecestat 50 mgn=72 Participants	-15.37	2.76
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgn=123 Participants	-18.37	2.09

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.