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. 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
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

  Participant Flow

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 5   4   9 
[Units: Years]
Mean (Standard Deviation)
 74.2  (8.7)   74.3  (3.3)   74.2  (6.5) 
[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

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

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

Responsible Party: TauRx Therapeutics Ltd 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