Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Azeliragon; Placebo
Intervention description: Azeliragon 5mg administered orally, once daily for 18 months; Placebo administered orally, once daily for 18 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 880.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; RAGE; ADAS-cog; CDR-sb

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.
    

Eligibility 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.