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

• Status: Terminated
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: vTv Therapeutics

Criteria

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