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: 12.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type
Conditions
Interventions
Product Name: Methylthioninium chloride capsules
Product Code: TRx0014
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLTHIONINIUM CHLORIDE
CAS Number: 61734
Current Sponsor code: TRx0014
Sponsors
TauRx Therapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of the study are to investigate the long term safety, tolerability and efficacy of oral TRx0014 at two doses (30 and 60 mg tid) in patients with AD. The long term safety and tolerability will be determined by frequent follow up, assessment of adverse events and measurement of haematological and biochemistry parameters. The long term efficacy will be determined by the continued assessment of: 1. cognitive ability measured by the Alzheimer’s Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE). 2. dementia severity assessed by the Clinical Dementia Rating – sum of the boxes (CDR-sb). 3. daily living activities assessed by the Alzheimer’s Disease functional Assessment and Change Scale (ADFACS) 4. Short CAMDEX - dementia caseness based on cut off scores on the cognitive and organicity sub-scales 5. Behavioural and psychological symptoms assessed by the Neuropsychiatric Inventory (NPI). ;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy variable in study TRx-014-001 was the change in cognitive function from Baseline as measured by the ADAS-cog. The individual patient data will be amalgamated with the data from TRx-014-001 to examine the long term potential of TRx0014 to slow the rate of decline by comparison with historical controls. | — |
Countries
United Kingdom
Outcome results
None listed