A study of Lanabecestat (LY3314814) in participants with mild Alzheimer's disease dementia - DAYBREAK-ALZ

Study identifier:16024

ClinicalTrials.gov identifier:NCT02783573

EudraCT identifier:2015-005625-39

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

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

Medical condition

Alzheimer's disease

Phase

Phase 3

Healthy volunteers

Study drug

Lanabecestat, Placebo

Sex

All

Actual Enrollment

1722

Study type

Interventional

Age

55 Years - 85 Years

Date

Study Start Date: 01 Jul 2016

Primary Completion Date: 28 Sept 2018

Study Completion Date: 28 Sept 2018

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2019 by AstraZeneca

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Experimental: Lanabecestat 20 milligrams (mg) Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293
Experimental: Lanabecestat 50 mg Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293
Experimental: Placebo/ Lanabecestat 20 mg Placebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293 Drug: Placebo Administered orally
Experimental: Placebo/ Lanabecestat 50 mg Placebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293 Drug: Placebo Administered orally

Documents available

Click here for more information about this study: A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)
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CSP
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SAP
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)