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Open Label Study of TRx0014 in 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.
ClinicalTrials.gov Identifier: NCT00684944
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Brief Summary:
This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: TRx0014 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease
Study Start Date : July 2007
Primary Completion Date : December 2010
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
30mg tid TRx0014
Drug: TRx0014
Gelatin capsule, tid
Active Comparator: 2
60mg tid TRx0014
Drug: TRx0014
Gelatin capsule, tid

Primary Outcome Measures :
  1. Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE). [ Time Frame: 0, 26 and 52 weeks ]

Secondary Outcome Measures :
  1. Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb). [ Time Frame: 0, 26 and 52 weeks ]
  2. Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS) [ Time Frame: 0, 26 and 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study.
  • Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
  • The patient must have been ongoing in TRx-014-001 at time of study termination.

Exclusion Criteria:

  • There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684944

Sponsors and Collaborators
TauRx Therapeutics Ltd
Principal Investigator: Peter Bentham, MRCPsych Queen Elizabeth Psychiatric Hospital, United Kingdom

Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT00684944     History of Changes
Other Study ID Numbers: TRx-014-009
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders