An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease

Participants who meet other study entry requirements will be required to undergo either an
amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid
(CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid
for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET
scan at screening will be included in the PET-substudy, and participants who undergo a lumbar
puncture at screening will be included in the CSF substudy until each of these substudies are
completed.

Inclusion Criteria:

- Gradual and progressive change in the participant's memory function over more than 6
months, reported by participant and study partner

- Mini-Mental State Examination score of 20-30 inclusive at screening

- Objective impairment in memory as evaluated by memory test performed at screening

- For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National
Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD

- For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD

Exclusion Criteria:

- Significant 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, serious infection of the brain, Parkinson´s disease, or epilepsy
or recurrent seizures

- History of clinically evident stroke, or multiple strokes based on history or imaging
results

- History of clinically important carotid or vertebrobasilar stenosis or plaque

- History of multiple concussions with sustained cognitive complaints or objective
change in neuropsychological function in the last 5 years

- Participants with a current Diagnostic and Statistical Manual of Mental Disorders,
Fifth Edition diagnosis of Major Depressive Disorder or 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 assessments, or affect the participant´s ability to complete the
study

- History of alcohol or drug abuse or dependence (except nicotine dependence) within 2
years before the screening

- Within 1 year before the screening or between screening and baseline, any of the
following: myocardial infarction; moderate or severe congestive heart failure, New
York Heart Association class III or IV; hospitalization for, or symptom of, unstable
angina; syncope due to orthostatic hypotension or unexplained syncope; known
significant structural heart disease (eg, significant valvular disease, hypertrophic
cardiomyopathy), or hospitalization for arrhythmia

- Congenital QT prolongation

- History of cancer within the last 5 years, with the exception of non-metastatic basal
and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive
prostate cancer or other cancers with low-risk of recurrence or spread

- Current serious or unstable clinically important systemic illness that, in the
judgment of the investigator, is likely to affect cognitive assessment, deteriorate,
or affect the participant's safety or ability to complete the study, including
hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,
immunologic, or hematologic disorders