2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Azeliragon 5mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 297.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; RAGE; ADAS-cog; CDR-sb

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.
    

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.