AN OPEN LABEL CONTINUATION STUDY OF THE EFFECTS OF MTC 30 MG TID AND 60 MG TID IN PATIENTS WITH ALZHEIMER’S DISEASE - Open Label Study of Methylthioninium Chloride (MTC) in Alzheimer’s Disease

• Conditions: An estimated 685,000 people in the UK suffer from dementia, with Alzheimer’s disease (AD) being the most common cause affecting over 400,000 people (Alzheimers Society 2007). It is a devastating illness which causes a progressive decline in mental ability and functional capacity and causes immense distress to patients, their carers and families and has an enormous societal impact.; MedDRA version: 12.0Level: PTClassification code 10012271Term: Dementia Alzheimer's type

• Registration Number: EUCTR2007-002470-59-GB
• Lead Sponsor: TauRx Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

To be eligible for the study all of the following criteria must be fulfilled:
1. 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.
2. 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.
3. The patient must have been ongoing in TRx-014-001 at time of study termination.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified