TRx0014 in Patients With Mild or Moderate Alzheimer's Disease

Exclusion Criteria

• •Patient has a known sensitivity to TRx0014, similar agents or any of the excipients used.
• •Screening blood sample shows that the patient has glucose-6-phosphate dehydrogenase deficiency.
• •Patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.
• •Patient has significant impairment of renal, hepatic or haematological function for the age of the patient.
• •Patient is currently taking other anti-dementia drugs (e.g. memantine, cholinesterase inhibitors) or has taken these within the previous six weeks.
• •It is anticipated that there will be a definite indication for the commencement of other licensed anti-dementia drug treatment within the 24 week treatment period of the trial.
• •Patient has started taking other medication known to have an effect on mood or cognition (e.g. anticholinergics, hypnotics, sedatives, anxiolytics, neuroleptics, antidepressants, antiepileptics) within the previous six weeks; or has changed their dose of these medications within the previous six weeks.
• •Patient has started taking 'alternative therapy' for AD e.g. vitamin E, folic acid, hormone replacement therapy (HRT), ginkgo biloba within the previous six weeks; or has changed their dose of these treatments within the previous six weeks.
• •Patient is receiving warfarin or digitalis or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were elevated or fell due to interaction with TRx0014.
• •Patients who are unlikely to comply with trial visit schedule or with trial medication.
• •Significant intercurrent illness which may compromise safety of the patient/validity of the data.
• •Females with the potential of childbearing and are not using adequate contraception or females who are breastfeeding.
• •Patients with a history of alcohol and/or drug abuse, defined as meeting DSM-IV criteria for substance dependence. This applies to alcohol and/or any illicit drug, including cannabis within the last six months.
• •Patient has participated in a clinical investigation of a medication or device within the previous three months.