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

Phase 2

Terminated

• Conditions: Alzheimer Disease
• Interventions: Drug: Placebo; Drug: Azeliragon

• Registration Number: NCT03980730
• Lead Sponsor: vTv Therapeutics

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Study Start: 2019-06-27
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-29
• Results First Submitted: 2021-11-16
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Results First Posted: 2022-01-21
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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
• Use of insulin therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Azeliragon	Azeliragon	Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)

Primary Outcome Measures

Name	Time	Method
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6	Baseline to Month 6	The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

Secondary Outcome Measures

Name	Time	Method
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6	Baseline to Month 6	Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6	Baseline to Month 6	The Amsterdam-Instrumental Activities of Daily Living score is calculated from a questionnaire consisting of 70 items in seven categories using an item response theory method of scoring. Scores range from 20 to 80 where lower scores indicate greater functional impairment.
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6	Baseline to Month 6	The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.	Baseline to Month 6	The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.

Trial Locations

Locations (31)

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; 🇺🇸 Stuart, 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

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