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

vTv Therapeutics31 sites in 2 countries43 target enrollmentJune 27, 2019

ConditionsAlzheimer Disease

InterventionsAzeliragon Placebo

DrugsAzeliragon Placebo

Overview

Phase: Phase 2
Intervention: Azeliragon
Conditions: Alzheimer Disease
Sponsor: vTv Therapeutics
Enrollment: 43
Locations: 31
Primary Endpoint: Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 27, 2019

End Date

January 29, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

vTv Therapeutics

Responsible Party

Sponsor

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
•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

Arms & Interventions

Azeliragon

Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)

Intervention: Azeliragon

Placebo

Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)

Intervention: Placebo

Outcomes

Primary Outcomes

Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6

Time Frame: 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 Outcomes

Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6(Baseline to Month 6)
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6(Baseline to Month 6)
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6(Baseline to Month 6)
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.(Baseline to Month 6)