Trial Outcomes & Findings for 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) (NCT NCT02916056)
NCT ID: NCT02916056
Last Updated: 2021-06-01
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
297 participants
Primary outcome timeframe
up to 18 months
Results posted on
2021-06-01
Participant Flow
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.
Participant milestones
| Measure |
Azeliragon 5 mg
Azeliragon (TTP488) 5mg orally once daily
|
|---|---|
|
Overall Study
STARTED
|
297
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
297
|
Reasons for withdrawal
| Measure |
Azeliragon 5 mg
Azeliragon (TTP488) 5mg orally once daily
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other
|
12
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Study Terminated by Sponsor
|
269
|
Baseline Characteristics
2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)
Baseline characteristics by cohort
| Measure |
Azeliragon 5 mg
n=297 Participants
Azeliragon (TTP488) 5mg orally once daily
|
|---|---|
|
Age, Continuous
|
74.9 years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
266 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
280 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 18 monthsPopulation: Safety Analysis Set
Outcome measures
| Measure |
Azeliragon 5 mg
n=297 Participants
Azeliragon (TTP488) 5mg orally once daily
|
|---|---|
|
Number of Subjects With at Least One Treatment-Emergent Adverse Event
|
193 Participants
|
Adverse Events
Azeliragon 5 mg
Serious events: 25 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azeliragon 5 mg
n=297 participants at risk
Azeliragon (TTP488) 5mg orally once daily
|
|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
3/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Ataxia
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Cerebral infarction
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Complex partial seizures
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Convulsion
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Dysarthria
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Syncope
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
2/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.67%
2/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Bacterial prostatitis
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Cellulitis
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Enterocolitis infectious
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Pneumonia
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Vascular disorders
Orthostatic hypotension
|
0.67%
2/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Vascular disorders
Aortic stenosis
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Cardiac disorders
Bradycardia
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Renal and urinary disorders
Renal failure acute
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.34%
1/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
Other adverse events
| Measure |
Azeliragon 5 mg
n=297 participants at risk
Azeliragon (TTP488) 5mg orally once daily
|
|---|---|
|
Nervous system disorders
Dizziness
|
4.0%
12/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Nervous system disorders
Headache
|
2.4%
7/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
9/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
9/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Psychiatric disorders
Depression
|
4.4%
13/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Psychiatric disorders
Insomnia
|
2.7%
8/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Fall
|
9.8%
29/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.0%
6/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
8/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
7/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
General disorders
Fatigue
|
2.4%
7/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
General disorders
Gait disturbance
|
2.4%
7/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Investigations
Weight decreased
|
3.0%
9/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
|
Vascular disorders
Hypertension
|
2.0%
6/297 • Adverse events were collected from consent through end of study participation. Duration of study participation was up to 456 days.
|
Additional Information
Ann Gooch PhD, VP Clinical Development & Regulatory Operations
vTv Therapeutics
Phone: 336-841-0300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Where PI requires the use of the Study Results for publication, the PI shall seek the Sponsor's written approval which shall not be unreasonably withheld; provided, however, that (i) Sponsor may require removal of any Confidential Information of Sponsor or may delay publication for a reasonable period of time in order to secure protection any IP Rights; and, (ii) as the Study is designed as a multi-center Study, no publication shall be made until after the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER