Trial Outcomes & Findings for Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease (NCT NCT01626391)
NCT ID: NCT01626391
Last Updated: 2014-07-11
Results Overview
This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-07-11
Participant Flow
Participant milestones
| Measure |
TRx0237
One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
|
Placebo
One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
TRx0237
One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
|
Placebo
One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
TRx0237
n=5 Participants
One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
|
Placebo
n=4 Participants
One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
74.2 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Anti-dementia Therapy
AChEI
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Anti-dementia Therapy
Memantine
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Anti-dementia Therapy
Both
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Safety Population
This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
Outcome measures
| Measure |
TRx0237
n=5 Participants
One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
|
Placebo
n=4 Participants
One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
|
|---|---|---|
|
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
|
4 participants
|
4 participants
|
Adverse Events
TRx0237
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TRx0237
n=5 participants at risk
One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
|
Placebo
n=4 participants at risk
One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Investigations
Electrocardiogram QT prolonged
|
20.0%
1/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
0.00%
0/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Investigations
Troponin I increased
|
20.0%
1/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
0.00%
0/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
25.0%
1/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
0.00%
0/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Psychiatric disorders
Intentional self-injury
|
20.0%
1/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
0.00%
0/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
20.0%
1/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
0.00%
0/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
|
Surgical and medical procedures
Tooth repair
|
20.0%
1/5 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
0.00%
0/4 • 8 weeks
At every visit, each subject was asked if he or she has experienced any adverse events and safety evaluations (including vital signs, clinical laboratory tests, pulse co-oximetry, 12-lead ECGs, physical and neurological evaluations, Columbia Suicide Severity Rating Scale and serotonin syndrome assessments) were performed throughout the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60