Open Label Study of TRx0014 in Alzheimer's Disease - Full Text View

Sponsored by:	TauRx Therapeutics Ltd
Information provided by:	TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:	NCT00684944

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 30mg tid TRx0014	Drug: TRx0014 Gelatin capsule, tid
2: Active Comparator 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 ( Professor Claude M. Wischik )
Study ID Numbers:	TRx-014-009
Study First Received:	May 22, 2008
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00684944 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009