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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 : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Azeliragon 5mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Extension Study for Continued Safety and Efficacy Evaluation of Azeliragon in Patients With Mild Alzheimer's Disease
Actual Study Start Date : December 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azeliragon 5 mg
Azeliragon (TTP488) 5mg orally once daily for 2 years
Drug: Azeliragon 5mg
Other Name: TTP488




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 years ]
  2. Clinical Safety Laboratory Tests [ Time Frame: 2 years ]
  3. Electrocardiogram [ Time Frame: 2 years ]
  4. Vital Signs [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The slope of change over time in Alzheimer's Disease Assessment Scale - cognitive measure (ADAS-cog) [ Time Frame: 2 years ]
  2. The slope of change over time in Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) [ Time Frame: 2 years ]
  3. The slope of change over time in Mini-Mental State Exam (MMSE) [ Time Frame: 2 years ]
  4. The slope of change over time in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale [ Time Frame: 2 years ]
  5. The slope of change over time in Neuropsychiatric Inventory Questionnaire (NPI) [ Time Frame: 2 years ]
  6. Change from baseline in measures of Alzheimer's Disease Assessment Scale - cognitive measure (ADAS-cog) [ Time Frame: 2 years ]
  7. Change from baseline in measures of Mini-Mental State Exam (MMSE) [ Time Frame: 2 years ]
  8. Change from baseline in measures of Clinical Dementia Rating (CDR) scale [ Time Frame: 2 years ]
  9. Change from baseline in measures of Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale [ Time Frame: 2 years ]
  10. Change from baseline in measures of Continuous Oral Word Association Task (COWAT) [ Time Frame: 2 years ]
  11. Change from baseline in measures of Category Fluency Test (CFT) [ Time Frame: 2 years ]
  12. Change from baseline in measures of Trail Making Test [ Time Frame: 2 years ]
  13. Change from baseline in measures of Neuropsychiatric Inventory Questionnaire (NPI) [ Time Frame: 2 years ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916056


  Show 71 Study Locations
Sponsors and Collaborators
vTv Therapeutics
Investigators
Study Director: Ann Gooch, Ph.D. vTv Therapeutics LLC

Additional Information:
Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT02916056     History of Changes
Other Study ID Numbers: TTP488-303
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by vTv Therapeutics:
Alzheimer's disease
RAGE
ADAS-cog
CDR-sb

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders