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

This study has been terminated.
(This study has been terminated for administrative reasons only.)
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01626391
First received: June 20, 2012
Last updated: June 10, 2014
Last verified: June 2014
Results First Received: April 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: TRx0237
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    TRx0237     Placebo  
STARTED     5     4  
COMPLETED     3     4  
NOT COMPLETED     2     0  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
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)
Total Total of all reporting groups

Baseline Measures
    TRx0237     Placebo     Total  
Number of Participants  
[units: participants]
  5     4     9  
Age  
[units: years]
Mean ± Standard Deviation
  74.2  ± 8.7     74.3  ± 3.3     74.2  ± 6.5  
Gender  
[units: participants]
     
Female     3     2     5  
Male     2     2     4  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     5     4     9  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     5     4     9  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United Kingdom     5     4     9  
Anti-dementia Therapy  
[units: participants]
     
AChEI     5     4     9  
Memantine     0     0     0  
Both     0     0     0  



  Outcome Measures

1.  Primary:   Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 8 weeks
Additional 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

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
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)

Other Adverse Events
    TRx0237     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     4/5     4/4  
Gastrointestinal disorders      
Dyspepsia † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Retching † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Vomiting † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Infections and infestations      
Lower respiratory tract infection † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Injury, poisoning and procedural complications      
Fall † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Investigations      
Urobilinogen urine increased † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Electrocardiogram QT prolonged † 1    
# participants affected / at risk     1/5 (20.00%)     0/4 (0.00%)  
Troponin I increased † 1    
# participants affected / at risk     1/5 (20.00%)     0/4 (0.00%)  
Musculoskeletal and connective tissue disorders      
Neck Pain † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Pain in Extremity † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Headache † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     1/5 (20.00%)     0/4 (0.00%)  
Intentional self-injury † 1    
# participants affected / at risk     1/5 (20.00%)     0/4 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Wheezing † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Skin and subcutaneous tissue disorders      
Hair colour changes † 1    
# participants affected / at risk     1/5 (20.00%)     0/4 (0.00%)  
Surgical and medical procedures      
Tooth repair † 1    
# participants affected / at risk     1/5 (20.00%)     0/4 (0.00%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     0/5 (0.00%)     1/4 (25.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 15.0



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: JHH@taurx.com


No publications provided


Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01626391     History of Changes
Other Study ID Numbers: TRx-237-008
Study First Received: June 20, 2012
Results First Received: April 28, 2014
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices