2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)
NCT ID: NCT02916056
Last Updated: 2021-06-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
297 participants
INTERVENTIONAL
2016-12-31
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azeliragon 5 mg
Azeliragon (TTP488) 5mg orally once daily for 2 years
Azeliragon 5mg
Interventions
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Azeliragon 5mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must enroll in the present study within 7 days of completion of study TTP488-301.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally authorized representative) and caregiver/informant has been informed of all pertinent aspects of the study. Participants must be able to provide assent (where this is in accordance with local laws, regulations and ethics committee policy) and assent may be re-evaluated during the study at regular intervals.
* Participants and caregiver/informants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* The subject must have a reliable caregiver/informant with regular contact (i.e., 10 hours a week as combination of face-to-face visits and telephone contact acceptable) who will facilitate the subject's full participation in the study. Caregivers/informant must have sufficient subject interaction to be able to provide meaningful input into the rating scales administered in this study where caregiver/informant input is required, in particular the CDR and evidence of this should be documented in source documentation. Participants who reside in assisted living facilities are permitted provided that they meet caregiver/informant criteria.
* Participants and caregiver/informants must be able to read, write, and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate psychometric testing.
* Subject must be able to ingest oral medications.
Exclusion Criteria
* Subjects with serious suicide risk. If there are "yes" answers on items 4, 5 or on any behavioral question of the C-SSRS, a suicide risk assessment must be done by a qualified mental health professional with expertise in the evaluation of suicidality in the elderly (e.g., psychiatrist, geriatrician or neurologist specializing in treatment of patients with AD) to determine whether it is safe for the subject to participate in the study.
* Subjects demonstrating a QTcF \> 480 msec or a \>45 msec change from the TTP488-301 Baseline value based on the locally read ECG performed at the TTP488-301 Month 18 Visit (TTP488-303 Baseline). Participants with known history of bundle branch block (either right or left) are allowed if absolute QTcF value does not exceed 500 msec. Participants with a functioning pacemaker, indicated by an ECG displaying paced rhythm, are allowed with no QTc upper limit.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may prevent the subject from completing the 2-year study or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
50 Years
ALL
No
Sponsors
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vTv Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Gooch, Ph.D.
Role: STUDY_DIRECTOR
vTv Therapeutics LLC
Locations
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Phoenix, Arizona, United States
Phoenix, 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
Riverside, California, United States
San Bernardino, California, United States
Santa Ana, California, United States
Atlantis, 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
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Sunrise, Florida, United States
The Villages, Florida, United States
Columbus, Georgia, United States
Chicago, Illinois, United States
Fairway, 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
St Louis, 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
Plains, Pennsylvania, United States
East Providence, Rhode Island, United States
East Providence, Rhode Island, United States
Cordova, 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
Calgary, Alberta, Canada
Medicine Hat, Alberta, Canada
Chatham, Ontario, Canada
Toronto, Ontario, Canada
Gatineau, Quebec, Canada
Greenfield Park, Quebec, Canada
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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TTP488-303
Identifier Type: -
Identifier Source: org_study_id
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