臨床研究等提出・公開システム

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

I8D-MC-AZET

Eli Lilly Japan K.K.

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Eli Lilly Japan K.K.

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+81-120-023-812

terminated

Sept. 27, 2016

Interventional

Study AZET is a multicenter, randomized, parallel-group, 78-week double-blind, placebo-controlled, study of 2 fixed doses of LY3314814.

treatment purpose

3

- 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.

- 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.

Both

Alzheimer's Disease Dementia

investigational material(s)
Generic name etc : LY3314814
INN of investigational material : Lanabecestat
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for Investigational material : Placebo given orally once daily for 78 weeks and then dose 2 of LY3314814 given orally once daily until week 156.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

confirmatory
Change in the primary endpoint measure, ADAS-Cog13 from baseline to the end of the Placebo- Controlled period

safety
efficacy
To evaluate the efficacy of LY3314814 at the end of the Placebo-Controlled period (week 78).
- ADCS-iADL score
- FAQ
- iADRS score
- CDR-SB
- CDR-Global Score
- NPI
- MMSE
To evaluate the effect of LY3314814 on biomarkers.
- CSF AB1-42 and AB1-40 concentrations
- CSF total tau and phosphorylated tau concentrations
- Florbetapir amyloid scan
- Florbetapir perfusion scan
- 18F-AV-1451 Tau PET
- FDG PET
- MRI
To evaluate the safety and tolerability of LY3314814.

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July. 15, 2016