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Open Label Study of TRx0014 in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00684944
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : April 27, 2018
Sponsor:
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
Actual Study Start Date : September 13, 2007
Actual Primary Completion Date : December 2, 2010
Actual Study Completion Date : December 2, 2010

Resource links provided by the National Library of Medicine


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, Older Adult
Sexes Eligible for Study:   All
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.

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
Investigators
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: April 27, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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