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Trial record 1 of 3 for:    Azeliragon | Alzheimer Disease
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2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)

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ClinicalTrials.gov Identifier: NCT02916056
Recruitment Status : Terminated (Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.)
First Posted : September 27, 2016
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • Adverse Events [ Time Frame: 2 years ]
  • Clinical Safety Laboratory Tests [ Time Frame: 2 years ]
  • Electrocardiogram [ Time Frame: 2 years ]
  • Vital Signs [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • The slope of change over time in Alzheimer's Disease Assessment Scale - cognitive measure (ADAS-cog) [ Time Frame: 2 years ]
  • The slope of change over time in Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) [ Time Frame: 2 years ]
  • The slope of change over time in Mini-Mental State Exam (MMSE) [ Time Frame: 2 years ]
  • The slope of change over time in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale [ Time Frame: 2 years ]
  • The slope of change over time in Neuropsychiatric Inventory Questionnaire (NPI) [ Time Frame: 2 years ]
  • Change from baseline in measures of Alzheimer's Disease Assessment Scale - cognitive measure (ADAS-cog) [ Time Frame: 2 years ]
  • Change from baseline in measures of Mini-Mental State Exam (MMSE) [ Time Frame: 2 years ]
  • Change from baseline in measures of Clinical Dementia Rating (CDR) scale [ Time Frame: 2 years ]
  • Change from baseline in measures of Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale [ Time Frame: 2 years ]
  • Change from baseline in measures of Continuous Oral Word Association Task (COWAT) [ Time Frame: 2 years ]
  • Change from baseline in measures of Category Fluency Test (CFT) [ Time Frame: 2 years ]
  • Change from baseline in measures of Trail Making Test [ Time Frame: 2 years ]
  • Change from baseline in measures of Neuropsychiatric Inventory Questionnaire (NPI) [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)
Official Title  ICMJE Open Label Extension Study for Continued Safety and Efficacy Evaluation of Azeliragon in Patients With Mild Alzheimer's Disease
Brief Summary This is an open-label extension study in patients with mild Alzheimer's disease who have completed participation in the azeliragon Phase 3 (STEADFAST) trial. Patients will receive azeliragon 5 mg/day for up to 2 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Azeliragon 5mg
Other Name: TTP488
Study Arms  ICMJE Experimental: Azeliragon 5 mg
Azeliragon (TTP488) 5mg orally once daily for 2 years
Intervention: Drug: Azeliragon 5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
298
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2016)
640
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful completion of Study TTP488-301 through the Month 18 Visit without ongoing serious adverse events or history of serious adverse drug reactions during study TTP488-301.
  • 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:

  • The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916056
Other Study ID Numbers  ICMJE TTP488-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party vTv Therapeutics
Study Sponsor  ICMJE vTv Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ann Gooch, Ph.D. vTv Therapeutics LLC
PRS Account vTv Therapeutics
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP