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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02080364

Run by

vTv Therapeutics

People needed

880

Starts

2015-04-01

Expected to finish

2018-06-01

Last updated by the study team

2021-05-07

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Bellflower, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Fullerton, California, United States
• Study site — Glendale, California, United States
• Study site — Imperial, California, United States
• Study site — Irvine, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Orange, California, United States
• Study site — Riverside, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Ana, California, United States
• Study site — Atlantis, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Hallandale, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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