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

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): NeuroStudies.net LLC
🇺🇸
Decatur, Georgia, United States
Q&T Research Sherbrooke Inc
🇨🇦
Sherbrooke, Quebec, Canada
Tucson Neuroscience Research
🇺🇸
Tucson, Arizona, United States
JEM Research Institute
🇺🇸
Atlantis, Florida, United States
The Cognitive and Research Center of New Jersey
🇺🇸
Springfield, New Jersey, United States
True North Clinical Research Inc.
🇨🇦
Kentville, Nova Scotia, Canada
Recherches Neuro-Hippocampe Inc.
🇨🇦
Gatineau, Quebec, Canada
Emory Alzheimer's Clinical Research Unit
🇺🇸
Atlanta, Georgia, United States
IU Health Partners, Adult Neurology Clinic
🇺🇸
Indianapolis, Indiana, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Summit Research Network
🇺🇸
Portland, Oregon, United States
Institute for Neurodegenerative Disorders
🇺🇸
New Haven, Connecticut, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Brain Matters Research
🇺🇸
Stuart, 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
Progressive Medical Research
🇺🇸
Port Orange, Florida, United States
Emerald Coast Center for Neurological Disorders
🇺🇸
Pensacola, Florida, United States
The Roskamp Institute
🇺🇸
Sarasota, Florida, United States
Memory Center / Hattiesburg Clinic
🇺🇸
Hattiesburg, Mississippi, United States
Millennium Psychiatric Associates
🇺🇸
Saint Louis, Missouri, United States
ANI Neurology dba Alzheimer's Memory Center
🇺🇸
Charlotte, North Carolina, United States
Neurological Associates of Long Island
🇺🇸
Lake Success, New York, United States
Clarity Clinical Research
🇺🇸
East Syracuse, New York, United States
Raleigh Neurology Associates
🇺🇸
Raleigh, North Carolina, United States
Wake Forest School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States
Center for Cognitive Health
🇺🇸
Portland, Oregon, United States
Okanagan Clinical Trials Ltd.
🇨🇦
Kelowna, British Columbia, Canada
Recherches Neuro-Hippocampe
🇨🇦
Ottawa, Ontario, Canada