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Open Label Study of TRx0014 in Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT00684944
First received: May 22, 2008
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Alzheimer's Disease
 Drug: TRx0014
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TauRx Therapeutics Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb). [ Time Frame: 0, 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS) [ Time Frame: 0, 26 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: July 2007
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
30mg tid TRx0014
 Drug: TRx0014
Gelatin capsule, tid
Active Comparator: 2
60mg tid TRx0014
 Drug: TRx0014
Gelatin capsule, tid

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684944

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

No publications provided

Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT00684944     History of Changes
Other Study ID Numbers: TRx-014-009
Study First Received: May 22, 2008
Last Updated: February 1, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013