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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Description
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- Diagnosis of all cause dementia and probable Alzheimer's disease
- Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score of 14-26 (inclusive)
- Age < 90 years
- Modified Hachinski ischemic score of ≤ 4
- Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
- Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
- Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
- If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, 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
- Significant central nervous system (CNS) disorder other than Alzheimer's disease
- Significant focal or vascular intracranial pathology seen on brain MRI scan
- Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
- Epilepsy
- Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or 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 Alzheimer's disease
- 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 3 months before Baseline with any of the following medications:
- Tacrine
- Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
- Carbamazepine, primidone
- Drugs associated with methemoglobinemia
- Current or prior participation in a clinical trial as follows:
- Clinical trial of a product for cognition within 3 months (unless confirmed to have been randomized to placebo)
- A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline
Sites
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California
- University of Southern California, Los Angeles, California, 90033
- Hoag Memorial Hospital Presbyterian, Newport Beach, California, 92658
- Feldman, Robert MD, Laguna Hills, California, 92653
- Pacific Research Network, San Diego, California, 92103
- San Francisco Clinical Research Center, San Francisco, California, 94118
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Arizona
- Xenoscience, Inc/ 21st Century Neurology, Phoenix, Arizona, 85004
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Texas
- FutureSearch Trials of Neurology, Austin, Texas, 78731
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Mississippi
- Olive Branch Family Medical, Olive Branch, Mississippi, 38654
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Illinois
- Alexian Brothers Neurosciences Institute, Elk Grove, Illinois, 60007
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Georgia
- iResearch Atlanta, Decatur, Georgia, 30030
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Spain
- Hospital Universitario de Ceuta, Ceuta, 51003
- Hospital Viamed Montecanal, Zaragoza, 50006
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Malaysia
- University Malaya Medical Centre, Kuala Lumpur, 50603
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