Clinical Trials

Inclusion Criteria

• Must meet the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's Disease 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
• 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
  • Cervicocranial vascular disease
• 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
  • Affect ability to complete the study
• History of schizophrenia or other chronic psychosis
• Within 1 year before the screening visit or between screening and randomization, has had 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
  • 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