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


  Limitations and Caveats


  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