Clinical trial NCT03980730: Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Receptor for Advanced Glycation Endproducts (RAGE)
ADAS-cog
CDR-sb
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-06-10
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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
* Use of insulin therapy

Primary outcomes:
measure: Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
timeFrame: Baseline to Month 6
measure: Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
timeFrame: Baseline to Month 6
measure: Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
timeFrame: Baseline to Month 6
measure: Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
timeFrame: Baseline to Month 6
Other outcomes:
measure: Count and Percentage of Subjects With Treatment-emergent Adverse Events
timeFrame: Baseline to Month 6
Locations:
city: Tucson
country: United States
facility: Tucson Neuroscience Research
state: Arizona
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Maitland
country: United States
facility: ClinCloud
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Center for Neurological Disorders
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: Atlanta
country: United States
facility: Emory Alzheimer's Clinical Research Unit
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net LLC
state: Georgia
city: Indianapolis
country: United States
facility: IU Health Partners, Adult Neurology Clinic
state: Indiana
city: Hattiesburg
country: United States
facility: Memory Center / Hattiesburg Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates
state: Missouri
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: East Syracuse
country: United States
facility: Clarity Clinical Research
state: New York
city: Lake Success
country: United States
facility: Neurological Associates of Long Island
state: New York
city: Charlotte
country: United States
facility: ANI Neurology dba Alzheimer's Memory Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Portland
country: United States
facility: Center for Cognitive Health
state: Oregon
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials Ltd.
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Inc.
state: Nova Scotia
city: Kentville
country: Canada
facility: True North Clinical Research Inc.
state: Nova Scotia
city: Ottawa
country: Canada
facility: Recherches Neuro-Hippocampe
state: Ontario
city: Gatineau
country: Canada
facility: Recherches Neuro-Hippocampe Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc
state: Quebec
Study officials:
References: