Open Label Study of TRx0014 in Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: TRx0014

• Registration Number: NCT00684944
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-13
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2010-12-02
• Study Completion: 2010-12-02
• Status Verified: 2018-04
• Disposition First Submitted: 2018-04-25
• Disposition First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Disposition First Posted: 2018-04-27
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TRx0014	30mg tid TRx0014
2	TRx0014	60mg tid TRx0014

Primary Outcome Measures

Name	Time	Method
Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).	0, 26 and 52 weeks

Secondary Outcome Measures

Name	Time	Method
Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).	0, 26 and 52 weeks
Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)	0, 26 and 52 weeks