Clinical Trial: Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (

Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the treatment of patients with behavioral variant frontotemporal dementia (bvFTD).

Detailed Summary:
Sponsor: TauRx Therapeutics Ltd

Current Primary Outcome:

  • Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R) [ Time Frame: 52 weeks ]
  • Change from Baseline on Functional Activities Questionnaire (FAQ) [ Time Frame: 52 weeks ]
  • Change from Baseline on whole brain volume (assessed by brain MRI) [ Time Frame: 52 weeks ]


Original Primary Outcome:

  • Change from Baseline in Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 52 weeks ]
  • Change from Baseline in Addenbrooke's Cognitive Examination - Revised (ACE-R) [ Time Frame: 52 weeks ]


Current Secondary Outcome:

  • Change from Baseline on Unified Parkinson's Disease Rating Scale (UPDRS Parts II and III) [ Time Frame: 52 weeks ]
  • Change from Baseline on Frontotemporal Dementia Rating Scale (FRS) [ Time Frame: 52 weeks ]
  • Change from Baseline on Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (modified ADCS-CGIC) [ Time Frame: 52 weeks ]
  • Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes [ Time Frame: 52 weeks ]
    Safety parameters included adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, assessment of serotonin syndrome, brain magnetic resonance imaging (MRI) and potential for suicidal behavior and thoughts


Original Secondary Outcome:

  • Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS Parts II and III) [ Time Frame: 52 weeks ]
  • Change from Baseline in Frontotemporal Dementia Rating Scale (FRS) [ Time Frame: 52 weeks ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) [ Time Frame: 52 weeks ]


Information By: TauRx Therapeutics Ltd

Dates:
Date Received: June 20, 2012
Date Started: May 2013
Date Completion:
Last Updated: April 7, 2016
Last Verified: April 2016