Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease

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.