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DAYBREAK-ALZ

TerminatedPhase 3Results posted

A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

Lead sponsor

AstraZeneca

Asset

Lanabecestat

Listed sites

262

Recruiting sites

-

Enrollment

1,722

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild AD dementia•Amyloid biomarker required•CDR global ≥0.5•MMSE 20-26•Study partner/caregiver required

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 ID16024
Eudract number2015-005625-39
Secondary IDI8D-MC-AZETEli Lilly and Company
NCT IDNCT02783573

Timeline

Milestones

Study first posted2016-05-26estimated
Study start2016-07-01actual
Primary completion2018-09-28actual
Study completion2018-09-28actual
Results first posted2019-08-06actual
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
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
•MMSE score of 20 to 26 inclusive at screening visit.
•For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
•Evidence of amyloid pathology.
•The participant must have a reliable study partner with whom he/she cohabits or has regular contact

Exclusion criteria

•Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
•Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
•Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
•Congenital QT prolongation.
•Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
•A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
•History of malignant cancer within the last 5 years.
•History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
•Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
•Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Endpoints (34)

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
8
Amyloid biomarkers
8
Function / daily living
4
Tau biomarkers
4
Other (unclassified)
4
Behavior / neuropsychiatric
2
Neuroimaging
2
Safety / tolerability / PK
2

Global cognition

8 endpoints
Primary/protocol endpoint

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 78

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 78

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=460 Participants6.421.23
Lanabecestat 20 mgn=471 Participants8.931.11
Lanabecestat 50 mgn=464 Participants6.201.32
LS Mean Difference (Final Values)2.5195% CI-0.752 - 5.776p0.129Mixed Models Analysis
LS Mean Difference (Final Values)-0.2195% CI-3.725 - 3.296p0.903Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:Baseline, Week 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage

Time frame:From Loss of 1 Global Stage through Week 78

time to event, event

Secondary/protocol endpoint

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

Time frame:Baseline, Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:Baseline, Week 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=369 Participants2.320.42
Lanabecestat 20 mgn=370 Participants2.570.41
Lanabecestat 50 mgn=363 Participants2.100.45
LS Mean Difference (Final Values)0.2595% CI-0.890 - 1.391p0.663Mixed Models Analysis
LS Mean Difference (Final Values)-0.2295% CI-1.423 - 0.983p0.717Mixed Models Analysis
Secondary/registry result

Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage

Time frame:From Loss of 1 Global Stage through Week 78

time to event, event

Posted result

GroupValue (median), DaysReported bounds
Placebon=479 Participants379-367 - 546
Lanabecestat 20 mgn=500 Participants367-365 - 456
Lanabecestat 50 mgn=466 Participants449-365 - 491
Secondary/registry result

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

Time frame:Baseline, Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=476 Participants-4.160.59
Lanabecestat 20 mgn=495 Participants-5.430.58
Lanabecestat 50 mgn=477 Participants-4.310.64
LS Mean Difference (Final Values)-1.2695% CI-2.891 - 0.362p0.126Mixed Models Analysis
LS Mean Difference (Final Values)-0.1595% CI-1.867 - 1.566p0.862Mixed Models Analysis

Function / daily living

4 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline, Week 78

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline, Week 78

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 78

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=357 Participants-3.951.27
Lanabecestat 20 mgn=369 Participants-6.911.29
Lanabecestat 50 mgn=347 Participants-7.131.40
LS Mean Difference (Final Values)-2.9595% CI-6.488 - 0.580p0.100Mixed Models Analysis
LS Mean Difference (Final Values)-3.1895% CI-6.876 - 0.525p0.092Mixed Models Analysis
Secondary/registry result

Change From Baseline in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline, Week 78

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=358 Participants3.930.81
Lanabecestat 20 mgn=369 Participants5.160.85
Lanabecestat 50 mgn=347 Participants3.410.91
LS Mean Difference (Final Values)1.2395% CI-1.045 - 3.499p0.285Mixed Models Analysis
LS Mean Difference (Final Values)-0.5295% CI-2.889 - 1.843p0.661Mixed Models Analysis

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, Week 78

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, Week 78

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=351 Participants3.451.70
Lanabecestat 20 mgn=363 Participants3.751.84
Lanabecestat 50 mgn=342 Participants0.441.45
LS Mean Difference (Final Values)0.3095% CI-4.297 - 4.889p0.899Mixed Models Analysis
LS Mean Difference (Final Values)-3.0195% CI-7.267 - 1.238p0.164Mixed Models Analysis

Amyloid biomarkers

8 endpoints
Secondary/protocol endpoint

Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42

Time frame:Baseline, Week 71

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40

Time frame:Baseline, Week 71

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 78

Amyloid PET Centiloid

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan

Time frame:Baseline, Week 78

change from baseline, improvement

Secondary/registry result

Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42

Time frame:Baseline, Week 71

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in Aβ1-42Standard error
Placebon=4 Participants23.6826.76
Lanabecestat 20 mgn=5 Participants-13.8724.30
Lanabecestat 50 mgn=5 Participants-17.0423.26
LS Mean Difference (Final Values)-37.5595% CI-122.35 - 47.26p0.343ANCOVA
LS Mean Difference (Final Values)-40.7295% CI-120.17 - 38.73p0.276ANCOVA
Secondary/registry result

Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40

Time frame:Baseline, Week 71

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in Aβ1-40Standard error
Placebon=4 Participants24.5223.08
Lanabecestat 20 mgn=5 Participants-37.4220.76
Lanabecestat 50 mgn=5 Participants-9.6320.74
LS Mean Difference (Final Values)-61.9495% CI-132.75 - 8.87p0.079ANCOVA
LS Mean Difference (Final Values)-34.1595% CI-104.88 - 36.59p0.303ANCOVA
Secondary/registry result

Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 78

Amyloid PET Centiloid

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=7 Participants-2.4310.47
Lanabecestat 20 mgn=10 Participants-0.217.79
Lanabecestat 50 mgn=7 Participants-17.639.69
LS Mean Difference (Final Values)2.2295% CI-26.569 - 31.017p0.873ANCOVA
LS Mean Difference (Final Values)-15.2095% CI-47.488 - 17.096p0.337ANCOVA
Secondary/registry result

Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan

Time frame:Baseline, Week 78

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Standard Uptake Value ratio (SUVr)Standard error
Placebon=82 Participants-0.030.01
Lanabecestat 20 mgn=65 Participants-0.030.01
Lanabecestat 50 mgn=66 Participants-0.030.01
LS Mean Difference (Final Values)0.0095% CI-0.015 - 0.017p0.927ANCOVA
LS Mean Difference (Final Values)0.0095% CI-0.015 - 0.017p0.930ANCOVA

Tau biomarkers

4 endpoints
Secondary/protocol endpoint

Change From Baseline in CSF Biomarker Total Tau

Time frame:Baseline, Week 71

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CSF Biomarker Phosphorylated Tau

Time frame:Baseline, Week 71

change from baseline, improvement

Secondary/registry result

Change From Baseline in CSF Biomarker Total Tau

Time frame:Baseline, Week 71

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Picogram per milliliter (pg/mL)Standard error
Placebon=4 Participants1.849.75
Lanabecestat 20 mgn=5 Participants18.169.77
Lanabecestat 50 mgn=5 Participants-11.219.32
LS Mean Difference (Final Values)16.3295% CI-16.015 - 48.659p0.283ANCOVA
LS Mean Difference (Final Values)-13.0595% CI-42.929 - 16.820p0.349ANCOVA
Secondary/registry result

Change From Baseline in CSF Biomarker Phosphorylated Tau

Time frame:Baseline, Week 71

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Picogram per milliliter (pg/mL)Standard error
Placebon=4 Participants2.221.54
Lanabecestat 20 mgn=5 Participants3.811.49
Lanabecestat 50 mgn=5 Participants0.081.41
LS Mean Difference (Final Values)1.5995% CI-3.457 - 6.640p0.494ANCOVA
LS Mean Difference (Final Values)-2.1395% CI-6.743 - 2.481p0.323ANCOVA

Neuroimaging

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Whole Brain Volume

Time frame:Baseline, Week 78

change from baseline, improvement

Secondary/registry result

Change From Baseline in Whole Brain Volume

Time frame:Baseline, Week 78

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), cm^3 (cubic centimeter)Standard error
Placebon=221 Participants-15.760.75
Lanabecestat 20 mgn=215 Participants-17.380.75
Lanabecestat 50 mgn=214 Participants-18.840.76
LS Mean Difference (Final Values)-1.6295% CI-3.708 - 0.464p0.127ANCOVA
LS Mean Difference (Final Values)-3.0895% CI-5.172 - -0.991p0.004ANCOVA

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat

Time frame:Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose

descriptive

Secondary/registry result

Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat

Time frame:Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose

descriptive

Posted result

GroupValue (geometric_mean), Liter per hour (L/h)Geometric coefficient of variation
Lanabecestatn=1077 Participants17.438.8

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Week 78

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Population PK: Central Volume of Distribution of Lanabecestat

Time frame:Predose, Week 4, 7, 19, 39, 45 and week 71 post dose

descriptive

Secondary/registry result/low confidence

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

Time frame:Baseline, Week 78

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=342 Participants-10.461.97
Lanabecestat 20 mgn=348 Participants-15.221.90
Lanabecestat 50 mgn=333 Participants-12.432.08
LS Mean Difference (Final Values)-4.7795% CI-10.103 - 0.56p0.079Mixed Models Analysis
LS Mean Difference (Final Values)-1.9795% CI-7.573 - 3.62p0.486Mixed Models Analysis
Secondary/registry result/low confidence

Population PK: Central Volume of Distribution of Lanabecestat

Time frame:Predose, Week 4, 7, 19, 39, 45 and week 71 post dose

descriptive

Posted result

GroupValue (geometric_mean), Liters (L)Geometric coefficient of variation
Lanabecestatn=1077 Participants77.8198

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.