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Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance

NCT03980730•vTv Therapeutics

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

50 - 85 years

Sex

ALL

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
•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

Exclusion Criteria

•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
+1 more criteria

Locations (33)

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

Key Dates

Start Date

June 27, 2019

Primary Completion Date

December 1, 2020

Completion Date

January 29, 2021

Last Updated

January 21, 2022

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

Azeliragon

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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