Clinical trial NCT02916056: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
RAGE
ADAS-cog
CDR-sb
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 297
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Subjects With at Least One Treatment-Emergent Adverse Event
timeFrame: up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Bellflower
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Glendale
country: United States
state: California
city: Imperial
country: United States
state: California
city: Irvine
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Atlantis
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: The Villages
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Fairway
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Newton
country: United States
state: Massachusetts
city: Plymouth
country: United States
state: Massachusetts
city: Quincy
country: United States
state: Massachusetts
city: Hattiesburg
country: United States
state: Mississippi
city: Creve Coeur
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Princeton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Shaker Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Plains
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: East Providence
country: United States
state: Rhode Island
city: Cordova
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
city: Calgary
country: Canada
state: Alberta
city: Medicine Hat
country: Canada
state: Alberta
city: Chatham
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Gatineau
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
Study officials:
affiliation: vTv Therapeutics LLC
name: Ann Gooch, Ph.D.
role: STUDY_DIRECTOR
References: