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

vTv Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Azeliragon; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02080364

TTP488-301

Details and patient eligibility

About

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.

Enrollment: 880 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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880 participants in 2 patient groups, including a placebo group

Azeliragon 5mg

Experimental group

Description:

Azeliragon (TTP488) 5mg orally once daily for 18 months

Treatment:

Drug: Azeliragon

Placebo

Placebo Comparator group

Description:

Placebo orally once daily for 18 months

Treatment:

Drug: Placebo