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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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).

Key facts

Study ID

NCT03980730

Run by

vTv Therapeutics

People needed

43

Starts

2019-06-27

Expected to finish

2021-01-29

Last updated by the study team

2022-01-21

Who can join

Age: 50 and older, up to 85. 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
• 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

You may not qualify if…

• 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

Where it is running

• Tucson Neuroscience Research — Tucson, Arizona, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Charter Research — Lady Lake, Florida, United States
• Alzheimer's Research and Treatment Center — Lake Worth, Florida, United States
• ClinCloud — Maitland, Florida, United States
• Synexus Clinical Research US — Orlando, Florida, United States
• Emerald Coast Center for Neurological Disorders — Pensacola, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• The Roskamp Institute — Sarasota, Florida, United States
• Brain Matters Research — Stuart, Florida, United States
• Emory Alzheimer's Clinical Research Unit — Atlanta, Georgia, United States
• NeuroStudies.net LLC — Decatur, Georgia, United States
• IU Health Partners, Adult Neurology Clinic — Indianapolis, Indiana, United States
• Memory Center / Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Millennium Psychiatric Associates — St Louis, Missouri, United States
• The Cognitive and Research Center of New Jersey — Springfield, New Jersey, United States
• Clarity Clinical Research — East Syracuse, New York, United States
• Neurological Associates of Long Island — Lake Success, New York, United States
• ANI Neurology dba Alzheimer's Memory Center — Charlotte, North Carolina, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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