Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease
NCT ID: NCT01689233
Last Updated: 2018-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2012-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRx0237 200 mg/day
TRx0237 200 mg/day
TRx0237 100 mg tablets will be administered twice daily.
Placebo
Placebo
Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
Interventions
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TRx0237 200 mg/day
TRx0237 100 mg tablets will be administered twice daily.
Placebo
Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
Eligibility Criteria
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Inclusion Criteria
* Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild) and MMSE score of 20-26 (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
Exclusion Criteria
* 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, 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 (unless otherwise noted):
* Tacrine
* Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
* Carbamazepine, primidone
* Drugs with a warning or precaution in the labeling of methemoglobinemia at approved doses
* Current or prior participation in a clinical trial as follows:
* Clinical trial of a product for cognition in which the last dose was received within 90 days prior to 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
89 Years
ALL
No
Sponsors
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TauRx Therapeutics Ltd
INDUSTRY
Responsible Party
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Locations
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Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, United States
NoesisPharma Clinical Trials
Phoenix, Arizona, United States
CITrials
Bellflower, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Southern California Research, LLC
Fountain Valley, California, United States
Feldman, Robert MD
Laguna Hills, California, United States
Synergy East
Lemon Grove, California, United States
Collaborative Neuroscience Network
Long Beach, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
Anderson Clinical Research
Redlands, California, United States
Pacific Research Network
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Neurological Research Institute
Santa Monica, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Mile High Research Center
Denver, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Research Center for Clinical Studies, Inc
Norwalk, Connecticut, United States
JEM Research
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
The Roskamp Institute, Inc.
Sarasota, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Compass Research, LLC - North Clinic
The Villages, Florida, United States
Premiere Research Institute (Palm Beach Neurology)
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Neurostudies.net
Decatur, Georgia, United States
Alexian Brothers Neurosciences Institute
Elk Grove, Illinois, United States
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States
CBH Health, LLC
Rockville, Maryland, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Olive Branch Family Medical
Olive Branch, Mississippi, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States
Memory Enhancement Centers of America, Inc
Eatontown, New Jersey, United States
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
Neurological Associates of Albany, P. C.
Albany, New York, United States
MedicalPsych Care, PLLC
Elmsford, New York, United States
Columbia University Taub Institute
New York, New York, United States
Research Foundation for Mental Hygiene, Inc.
Orangeburg, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Clinical Trials of America, Inc
Winston-Salem, North Carolina, United States
Neurobehavorial Clinical Research
Canton, Ohio, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
RI Hospital
Providence, Rhode Island, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, United States
Senior Adults Specialty Research, Inc.
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
PRA Health Sciences
Salt Lake City, Utah, United States
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States
Discipline of Psychiatry, University of Queensland
Herston, Queensland, Australia
University Hospital Brussels Department of Neurology
Brussels, , Belgium
University Hospital Gent Department of Neurology
Ghent, , Belgium
Jessa Hospital
Hasselt, , Belgium
Regional Hospital Sint-Trudo
Sint-Truiden, , Belgium
GasthuisZusters Antwerpen Sint-Augustinus
Wilrijk, , Belgium
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, Canada
Parkwood Institute
London, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
University Hospital Centre Zagreb, Department of Neurology
Zagreb, , Croatia
University Psychiatric Hospital Vrapče
Zagreb, , Croatia
University of Eastern Finland, Brain Research Unit Mediteknia
Kuopio, , Finland
Clinical Research Services Turku (CRST)
Turku, , Finland
Hôpitaux Civils de Colmar
Colmar, , France
Hôpital La Grave
Toulouse, , France
Hôpital de Charpennes
Villeurbanne, , France
Neurozentrum Achim Dr. med. Andreas Mahler
Achim, , Germany
University Medicine Berlin - Charité, CBF, Neurology
Berlin, , Germany
Memory Clinic, ECRC
Berlin, , Germany
Arzeneimittelforschung Leipzig GmbH
Leipzig, , Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock
Rostock, , Germany
A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, , Italy
IRCCS San Giovanni di Dio - Fatebenefratelli
Brescia, , Italy
Fondazione Universita 'G. D'Annunzio di Chieti
Chieti Scalo, , Italy
Clinical Neurology Department of Neuroscience (DINOGMI) - University of Genoa
Genova, , Italy
Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia
Roma, , Italy
Alzheimer Center Southwest Netherlands, Erasmus MC
Rotterdam, , Netherlands
Fundacio ACE
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari Mútua de Terrassa
Terrassa, , Spain
Grampian NHS, Royal Cornhill Hospital
Aberdeen, , United Kingdom
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
Crowborough, , United Kingdom
Re:Cogniton Health
London, , United Kingdom
Memory Assessment and Research Centre (MARC)
Southampton, , United Kingdom
Kingshill Research Centre, Victoria Hospital
Swindon, , United Kingdom
Countries
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Related Links
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Alzheimer's Survey
Other Identifiers
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TRx-237-005
Identifier Type: -
Identifier Source: org_study_id
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