safety study of trx0237 in patients already taking medications for mild and moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary purpose of this study is to assess the safety and tolerability of trx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria * clinical diagnosis of all cause dementia and probable alzheimer's disease (ad) * mini-mental state examination (mmse) score of 14-26 (inclusive) * cognitive impairment present for at least 6 months * age ≤90 years * modified hachinski ischaemic score of ≤4 * females, if of childbearing potential, must use adequate contraception and maintain this use throughout participation in the study * patient is able to read, understand, and provide written informed consent * has one or more identified caregivers who are able to verify daily compliance with study drug and provide information on safety and tolerability; the caregiver(s) must also give consent to participate * currently taking an taking an acetylcholinesterase inhibitor and/or memantine; the subject must have been taking such medication(s) for ≥3 months. the dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study. * able to comply with the study procedures exclusion criteria: * significant central nervous system disorder other than alzheimer's disease * patients in whom baseline mri is contraindicated such as metal implants in head (except dental), pacemaker, and cochlear implant * significant focal or intracranial pathology that would lead to a diagnosis other than probable alzheimer's disease * clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness * epilepsy * major depressive disorder, schizophrenia or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders * resides in a hospital or continuous care facility * history of swallowing difficulties * pregnant or breastfeeding * history of significant hematological abnormality or current acute or chronic clinically significant abnormality * abnormal serum chemistry laboratory value at screening deemed to be clinically relevant by the investigator * clinically significant cardiovascular disease or abnormal assessments * pre-existing or current signs or symptoms of respiratory failure * concurrent acute or chronic clinically significant immunologic, renal, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than alzheimer's disease * prior intolerance to methylthioninium-containing drug or any of the excipients * treatment currently or within 3 months before baseline with any of the following medications (unless otherwise noted): * tacrine * anxiolytics and/or sedatives/hypnotics (exceptions: sedation for mri or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime) * antipsychotics (clozapine, chlorpromazine, thioridazine, or ziprasidone) * carbamazepine * drugs associated with methaemoglobinaemia (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials, sulfonamides) * warfarin (and other coumadin derivates such as phenprocoumon) * current or prior participation in a clinical trial of a drug, biologic, or device in which the last dose was received within 28 days prior to baseline

Keywords: alzheimer's disease trx0237 safety study ad