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

Open Label Extension Study for Continued Safety and Efficacy Evaluation of Azeliragon in Patients With Mild Alzheimer's Disease

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Azeliragon 5mg

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
    • Medicine Hat, Alberta, Canada, T1B 4E7
  • Ontario
    • Chatham, Ontario, Canada, N7L 1C1
    • Toronto, Ontario, Canada, M3B 2S7
  • Quebec
    • Gatineau, Quebec, Canada, J8T 8J1
    • Greenfield Park, Quebec, Canada, J4V 2J2
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
    • Phoenix, Arizona, United States, 85004
    • Tucson, Arizona, United States, 85724
  • California
    • Bellflower, California, United States, 90706
    • Costa Mesa, California, United States, 92626
    • Fullerton, California, United States, 92835
    • Glendale, California, United States, 91206
    • Imperial, California, United States, 92251
    • Irvine, California, United States, 92614
    • Laguna Hills, California, United States, 92653
    • Long Beach, California, United States, 90806
    • Riverside, California, United States, 92506
    • San Bernardino, California, United States, 92408
    • Santa Ana, California, United States, 92705
  • Florida
    • Atlantis, Florida, United States, 33462
    • Delray Beach, Florida, United States, 33445
    • Hallandale Beach, Florida, United States, 33009
    • Hialeah, Florida, United States, 33016
    • Jacksonville, Florida, United States, 32216
    • Lake Worth, Florida, United States, 33449
    • Miami, Florida, United States, 33137
    • Miami, Florida, United States, 33122
    • Miami Beach, Florida, United States, 33140
    • Miami Lakes, Florida, United States, 33014
    • Orlando, Florida, United States, 32806
    • Sarasota, Florida, United States, 34243
    • Sunrise, Florida, United States, 33351
    • The Villages, Florida, United States, 32162
  • Georgia
    • Columbus, Georgia, United States, 31909
  • Illinois
    • Chicago, Illinois, United States, 60640
  • Kansas
    • Fairway, Kansas, United States, 66205
  • Kentucky
    • Lexington, Kentucky, United States, 40504
  • Maryland
    • Baltimore, Maryland, United States, 21208
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
    • Plymouth, Massachusetts, United States, 02360
    • Quincy, Massachusetts, United States, 02169
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
    • Saint Louis, Missouri, United States, 63141
  • New Jersey
    • Princeton, New Jersey, United States, 08540
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
  • New York
    • Albany, New York, United States, 12208
    • Lake Success, New York, United States, 11042
    • New York, New York, United States, 10032
    • Staten Island, New York, United States, 10312
  • North Carolina
    • Charlotte, North Carolina, United States, 28270
    • Raleigh, North Carolina, United States, 27607
    • Wilmington, North Carolina, United States, 28401
    • Winston-Salem, North Carolina, United States, 27157
  • Ohio
    • Canton, Ohio, United States, 44718
    • Shaker Heights, Ohio, United States, 44122
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
    • Oklahoma City, Oklahoma, United States, 73118
  • Oregon
    • Portland, Oregon, United States, 97210
    • Portland, Oregon, United States, 97225
  • Pennsylvania
    • Plains, Pennsylvania, United States, 18705
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
    • East Providence, Rhode Island, United States, 02916
  • Tennessee
    • Cordova, Tennessee, United States, 38018
  • Texas
    • Dallas, Texas, United States, 75231
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78232
    • Wichita Falls, Texas, United States, 76309
  • Utah
    • Murray, Utah, United States, 84123
  • Washington
    • Kirkland, Washington, United States, 98033

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Azeliragon 5 mg; Azeliragon (TTP488) 5mg orally once daily for 2 years	Drug: Azeliragon 5mg; Other Names: TTP488

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects With at Least One Treatment-Emergent Adverse Event	up to 18 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Alzheimer's disease; RAGE; ADAS-cog; CDR-sb
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: TTP488-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No