Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Exclusion Criteria

• •Significant central nervous system (CNS) disorder other than bvFTD
• •Significant intracranial pathology seen on brain MRI scan
• •Biomarker evidence of underlying Alzheimer's disease pathology
• •Expressive language deficits
• •Meets research criteria for Amyotrophic Lateral Sclerosis or motor neuron disease
• •Meets diagnostic criteria for probable bvFTD but has a proven mutation producing non-tau, non-TDP-43 pathology
• •Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
• •Epilepsy
• •Rapid eye movement sleep behavior disorder
• •Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
• •Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
• •Resides in hospital or moderate to high dependency continuous care facility
• •History of swallowing difficulties
• •Pregnant or breastfeeding
• •Glucose-6-phosphate dehydrogenase deficiency
• •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
• •Preexisting or current signs or symptoms of respiratory failure
• •Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than bvFTD
• •Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
• •Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
• •Treatment currently or within 90 days before Baseline with any of the following medications (unless otherwise noted):
• •* Tacrine
• •* Amphetamine or dexamphetamine
• •* Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
• •* Carbamazepine, primidone
• •* Drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses
• •Current or prior participation in a clinical trial as follows:
• •* Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)
• •* A clinical trial of a drug, biologic, device, or medical food in which the last dose/administration was received within 28 days prior to Baseline