Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance

Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance

This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).

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
• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
• 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 2 months prior to screening
• Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive
• 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
• Previous clinical trial participation within 90 days of screening
• Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year 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 current treatment
• Women of childbearing potential
• Uncontrolled blood pressure and/or blood pressure above 140/90
• Participants receiving medications that may negatively impact cognitive function
• History of diabetic ketoacidosis within the past year
• History of chronic pancreatitis
• Stage 4 kidney disease
• Use of insulin therapy