A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Intervention: Lanabecestat; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1722.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: dementia; brain diseases; neurodegenerative diseases; central nervous system diseases; nervous system diseases; mental disorders; delirium, dementia, amnestic, cognitive; tauopathies; memory; amyloid

Summary:

      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.
    

Eligibility 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.