Clinical Trial: Open-Label Study of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: An Open-Label, Extension Study of the Effects of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

Brief Summary: The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term safety of TRx0237.

Detailed Summary:
Sponsor: TauRx Therapeutics Ltd

Current Primary Outcome:

• Number of participants with serious and non-serious adverse events [ Time Frame: Up to 37 months ]
• Change from Baseline in laboratory test values [ Time Frame: Up to 37 months ]
  Standard hematology and serum chemistry parameters to be measured
• Change from Baseline in vital signs [ Time Frame: Up to 37 months ]
  Vital signs to be measured include blood pressure and pulse, temperature, respiratory rate and weight

Original Primary Outcome:

• Number of participants with serious and non-serious adverse events [ Time Frame: Up to 29 months ]
• Change from Baseline in laboratory test values [ Time Frame: Up to 29 months ]
  Standard hematology and serum chemistry parameters to be measured
• Change from Baseline in vital signs [ Time Frame: Up to 29 months ]
  Vital signs to be measured include blood pressure and pulse

Current Secondary Outcome:

Original Secondary Outcome:

Information By: TauRx Therapeutics Ltd

Dates:
Date Received: August 27, 2014
Date Started: August 2014
Date Completion: September 2017
Last Updated: June 20, 2016
Last Verified: June 2016