
    not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.
  
["alzheimer's disease"]
['azeliragon', 'placebo']

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression
             of disease

          -  Mini Mental State Examination (MMSE) score of 21-26, inclusive

          -  Clinical Dementia Rating global score of 0.5 or 1

          -  Rosen-Modified Hachinski Ischemia Score less than or equal to 4

          -  Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD

          -  Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least
             3 months prior to randomization

          -  Caregiver willing to participate and be able to attend clinic visits with patient

          -  Ability to ingest oral medications

        Exclusion Criteria:

          -  Significant neurological or psychiatric disease other than Alzheimer's disease

          -  Participants with evidence or history of severe drug allergies (resulting in dyspnea
             or severe rash).

          -  Any contraindications to MRI (e.g., clinically significant claustrophobia,
             non-removable ferromagnetic implants). Patients with contraindications to MRI may
             undergo computed tomography (CT) on approval by sponsor.

          -  Any contraindications to the FDG-PET study (e.g. allergy to any component of the FDG
             dose) in the cohort undergoing a PET scan.

          -  Previous exposure to investigational or non-investigational therapies for Alzheimer's
             disease within 6 months of screening

          -  History of cancer within the last 5 years except adequately treated cervical carcinoma
             in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate
             cancer not requiring treatment

          -  Women of childbearing potential

          -  Uncontrolled blood pressure and/or blood pressure above 160/100

          -  Prescription medical food intended for dietary management of the metabolic processes
             associated with Alzheimer's disease.

          -  Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral
             hemorrhage, intracranial tumor, subarachnoid hemorrhage.

          -  Patients with unstable, uncontrolled diabetes (HbA1c > 7.7%) and those requiring
             insulin.
      