Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, RAGE, ADAS-cog, CDR-sb
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.
Interventions
DRUGAzeliragon 5mg
Sponsors
vTv Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With at Least One Treatment-Emergent Adverse Event | up to 18 months |
Countries
Canada, United States
Participant flow
Recruitment details
Eligible participants who completed TTP488-301 were enrolled into the TTP488-303 Open label extension from December 2016 through April 2018 in the United States and Canada.
Participants by arm
| Arm | Count |
|---|---|
| Azeliragon 5 mg Azeliragon (TTP488) 5mg orally once daily | 297 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 12 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Study Terminated by Sponsor | 269 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Azeliragon 5 mg |
|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 8.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 266 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 280 Participants |
| Sex: Female, Male Female | 144 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 297 |
| other Total, other adverse events | 137 / 297 |
| serious Total, serious adverse events | 25 / 297 |
Outcome results
Primary
Number of Subjects With at Least One Treatment-Emergent Adverse Event
Time frame: up to 18 months
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Azeliragon 5 mg | Number of Subjects With at Least One Treatment-Emergent Adverse Event | 193 Participants |