Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
NCT ID: NCT03980730
Last Updated: 2022-01-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
43 participants
INTERVENTIONAL
2019-06-27
2021-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Azeliragon
Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Azeliragon
Azeliragon 5 mg capsule administered orally, once daily
Placebo
Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Placebo
Matching placebo capsule administered orally, once daily
Interventions
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Azeliragon
Azeliragon 5 mg capsule administered orally, once daily
Placebo
Matching placebo capsule administered orally, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
85 Years
ALL
No
Sponsors
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vTv Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Progressive Medical Research
Port Orange, Florida, United States
The Roskamp Institute
Sarasota, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Emory Alzheimer's Clinical Research Unit
Atlanta, Georgia, United States
NeuroStudies.net LLC
Decatur, Georgia, United States
IU Health Partners, Adult Neurology Clinic
Indianapolis, Indiana, United States
Memory Center / Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Millennium Psychiatric Associates
St Louis, Missouri, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Clarity Clinical Research
East Syracuse, New York, United States
Neurological Associates of Long Island
Lake Success, New York, United States
ANI Neurology dba Alzheimer's Memory Center
Charlotte, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Summit Research Network
Portland, Oregon, United States
Center for Cognitive Health
Portland, Oregon, United States
Okanagan Clinical Trials Ltd.
Kelowna, British Columbia, Canada
True North Clinical Research Inc.
Halifax, Nova Scotia, Canada
True North Clinical Research Inc.
Kentville, Nova Scotia, Canada
Recherches Neuro-Hippocampe
Ottawa, Ontario, Canada
Recherches Neuro-Hippocampe Inc.
Gatineau, Quebec, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TTP488-305
Identifier Type: -
Identifier Source: org_study_id
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