2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)

• ClinicalTrials.gov Identifier: NCT02916056
• Recruitment Status: Terminated
• First Posted: September 27, 2016
• Last Update Posted: May 17, 2019
• Sponsor: vTv Therapeutics
• Information provided by (Responsible Party): vTv Therapeutics

Tracking Information

• First Submitted Date: August 10, 2016
• First Posted Date: September 27, 2016
• Last Update Posted Date: May 17, 2019
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Alzheimer's Disease

Intervention

Drug: Azeliragon 5mg

Other Name: TTP488

Study Arms

Experimental: Azeliragon 5 mg

Azeliragon (TTP488) 5mg orally once daily for 2 years

Intervention: Drug: Azeliragon 5mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 30, 2018): 298
• Original Estimated Enrollment (submitted: September 22, 2016): 640
• Actual Study Completion Date: June 1, 2018
• Actual Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02916056
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: vTv Therapeutics
• Study Sponsor: vTv Therapeutics
• Collaborators: Not Provided

Investigators

• Study Director: Ann Gooch, Ph.D.; vTv Therapeutics LLC

• PRS Account: vTv Therapeutics
• Verification Date: May 2019