ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01626391
Recruitment Status : Terminated (This study has been terminated for administrative reasons only.)
First Posted : June 22, 2012
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: TRx0237
Drug: Placebo
Enrollment 9

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TRx0237 Placebo
Hide Arm/Group Description One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237) One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
Period Title: Overall Study
Started 5 4
Completed 3 4
Not Completed 2 0
Reason Not Completed
Physician Decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title TRx0237 Placebo Total
Hide Arm/Group Description One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237) One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237) Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
74.2  (8.7) 74.3  (3.3) 74.2  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
3
  60.0%
2
  50.0%
5
  55.6%
Male
2
  40.0%
2
  50.0%
4
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
4
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
4
 100.0%
9
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 5 participants 4 participants 9 participants
5 4 9
Anti-dementia Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
AChEI 5 4 9
Memantine 0 0 0
Both 0 0 0
1.Primary Outcome
Title Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
Hide Description This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TRx0237 Placebo
Hide Arm/Group Description:
One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
Overall Number of Participants Analyzed 5 4
Measure Type: Number
Unit of Measure: participants
4 4
Time Frame 8 weeks
Adverse Event Reporting Description 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
 
Arm/Group Title TRx0237 Placebo
Hide Arm/Group Description One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237) One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
All-Cause Mortality
TRx0237 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TRx0237 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TRx0237 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/5 (80.00%)   4/4 (100.00%) 
Gastrointestinal disorders     
Dyspepsia  1  0/5 (0.00%)  1/4 (25.00%) 
Retching  1  0/5 (0.00%)  1/4 (25.00%) 
Vomiting  1  0/5 (0.00%)  1/4 (25.00%) 
Infections and infestations     
Lower respiratory tract infection  1  0/5 (0.00%)  1/4 (25.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/5 (0.00%)  1/4 (25.00%) 
Investigations     
Urobilinogen urine increased  1  0/5 (0.00%)  1/4 (25.00%) 
Electrocardiogram QT prolonged  1  1/5 (20.00%)  0/4 (0.00%) 
Troponin I increased  1  1/5 (20.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck Pain  1  0/5 (0.00%)  1/4 (25.00%) 
Pain in Extremity  1  0/5 (0.00%)  1/4 (25.00%) 
Nervous system disorders     
Dizziness  1  0/5 (0.00%)  1/4 (25.00%) 
Headache  1  0/5 (0.00%)  1/4 (25.00%) 
Psychiatric disorders     
Depression  1  1/5 (20.00%)  0/4 (0.00%) 
Intentional self-injury  1  1/5 (20.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/5 (0.00%)  1/4 (25.00%) 
Wheezing  1  0/5 (0.00%)  1/4 (25.00%) 
Skin and subcutaneous tissue disorders     
Hair colour changes  1  1/5 (20.00%)  0/4 (0.00%) 
Surgical and medical procedures     
Tooth repair  1  1/5 (20.00%)  0/4 (0.00%) 
Vascular disorders     
Hypertension  1  0/5 (0.00%)  1/4 (25.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Early termination leading to small numbers of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jiri Hardlund
Organization: TauRx Therapeutics Ltd
Phone: +44 (0)1224438550
EMail: JHH@taurx.com
Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01626391     History of Changes
Other Study ID Numbers: TRx-237-008
First Submitted: June 20, 2012
First Posted: June 22, 2012
Results First Submitted: April 28, 2014
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014