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

• Status: Terminated
• Trial end date: 2018-06-01
• 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. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 18 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: vTv Therapeutics
• Treatments: Cholinesterase Inhibitors

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

• 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.