Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
NCT ID: NCT02080364
Last Updated: 2021-05-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
880 participants
INTERVENTIONAL
2015-04-30
2018-06-01
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 5mg
Azeliragon (TTP488) 5mg orally once daily for 18 months
Azeliragon
Azeliragon 5mg administered orally, once daily for 18 months
Placebo
Placebo orally once daily for 18 months
Placebo
Placebo administered orally, once daily for 18 months
Interventions
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Azeliragon
Azeliragon 5mg administered orally, once daily for 18 months
Placebo
Placebo administered orally, once daily for 18 months
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
* Rosen-Modified Hachinski Ischemia Score less than or equal to 4
* 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 3 months prior to randomization
* Caregiver willing to participate and be able to attend clinic visits with patient
* Ability to ingest oral medications
Exclusion Criteria
* Participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
* Any contraindications to MRI (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). Patients with contraindications to MRI may undergo computed tomography (CT) on approval by sponsor.
* Any contraindications to the FDG-PET study (e.g. allergy to any component of the FDG dose) in the cohort undergoing a PET scan.
* Previous exposure to investigational or non-investigational therapies for Alzheimer's disease within 6 months 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 treatment
* Women of childbearing potential
* Uncontrolled blood pressure and/or blood pressure above 160/100
* Prescription medical food intended for dietary management of the metabolic processes associated with Alzheimer's disease.
* Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage.
* Patients with unstable, uncontrolled diabetes (HbA1c \> 7.7%) and those requiring insulin.
50 Years
ALL
No
Sponsors
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vTv Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Aaron H Burstein, PharmD
Role: STUDY_DIRECTOR
vTv Therapeutics
Locations
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Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Bellflower, California, United States
Costa Mesa, California, United States
Fullerton, California, United States
Glendale, California, United States
Imperial, California, United States
Irvine, California, United States
Laguna Hills, California, United States
Long Beach, California, United States
Long Beach, California, United States
Orange, California, United States
Riverside, California, United States
San Bernardino, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Atlantis, Florida, United States
Brooksville, Florida, United States
Delray Beach, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Lake Worth, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Sarasota, Florida, United States
Sunrise, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Chicago, Illinois, United States
Fairway, Kansas, United States
Prairie Village, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Newton, Massachusetts, United States
Plymouth, Massachusetts, United States
Quincy, Massachusetts, United States
Hattiesburg, Mississippi, United States
Creve Coeur, Missouri, United States
Princeton, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Lake Success, New York, United States
New York, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Shaker Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Portland, Oregon, United States
Media, Pennsylvania, United States
Norristown, Pennsylvania, United States
Plains, Pennsylvania, United States
East Providence, Rhode Island, United States
East Providence, Rhode Island, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Cordova, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Murray, Utah, United States
Kirkland, Washington, United States
Richland, Washington, United States
Southport, Queensland, Australia
Caulfield, Victoria, Australia
Geelong, Victoria, Australia
Heidelberg West, Victoria, Australia
Nedlands, Western Australia, Australia
West Perth, Western Australia, Australia
Calgary, Alberta, Canada
Medicine Hat, Alberta, Canada
Kentville, Nova Scotia, Canada
Chatham, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Gatineau, Quebec, Canada
Greenfield Park, Quebec, Canada
Cork, , Ireland
Dublin, , Ireland
Galway, , Ireland
Christchurch, Canterbury, New Zealand
Christchurch, Canterbury, New Zealand
Cape Town, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Saint George, , South Africa
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Northampton, , United Kingdom
Oxford, , United Kingdom
Penarth, , United Kingdom
Preston, , United Kingdom
Sheffield, , United Kingdom
Southhampton, , United Kingdom
Swindon, , United Kingdom
Warrington, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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TTP488-301
Identifier Type: -
Identifier Source: org_study_id
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