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

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Lanabecestat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02783573

16024

I8D-MC-AZET (Other Identifier)

2015-005625-39 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

Enrollment: 1,722 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,722 participants in 4 patient groups

Lanabecestat 20 milligrams (mg)

Experimental group

Description:

Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.

Treatment:

Drug: Lanabecestat

Lanabecestat 50 mg

Experimental group

Description:

Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.

Treatment:

Drug: Lanabecestat

Placebo/ Lanabecestat 20 mg

Experimental group

Description:

Placebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.

Treatment:

Drug: Placebo

Drug: Lanabecestat

Placebo/ Lanabecestat 50 mg

Experimental group

Description:

Placebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.

Treatment:

Drug: Placebo

Drug: Lanabecestat