Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
- Conditions
- Behavioral Variant Frontotemporal DementiaAlzheimer's Disease
- Interventions
- Registration Number
- NCT02245568
- Lead Sponsor
- TauRx Therapeutics Ltd
- Brief Summary
The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 913
- Subjects with all cause dementia and probable Alzheimer's disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.
- Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
- Females, if of child-bearing potential, must practice true abstinence or continue 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 and ethics approval is/are able to read, understand, and provide written informed consent
- Has an 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 ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
- Able to comply with the study procedures
- History of swallowing difficulties
- Pregnant or breastfeeding
- Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit
- Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food
- In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LMTM LMTM -
- Primary Outcome Measures
Name Time Method Number of Participants With Serious or Non-serious Adverse Events Up to 34 months Study-emergent adverse events (including the onset of new adverse events or worsening of pre-existing adverse events) were recorded from the time of first dose in this study to the end of study participation. All laboratory test, vital sign, or electrocardiogram parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (132)
Feldman, Robert MD
🇺🇸Laguna Hills, California, United States
The Shankle Clinic
🇺🇸Newport Beach, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Hôpital de Charpennes
🇫🇷Villeurbanne, France
University Kuala Lumpur Royal College of Medicine
🇲🇾Ipoh, Malaysia
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
🇷🇴Sibiu, Romania
True North Clinical Research Halifax Inc
🇨🇦Halifax, Nova Scotia, Canada
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Clinical Research Services Turku (CRST)
🇫🇮Turku, Finland
National Neuroscience Institute (NNI)
🇸🇬Singapore, Singapore
Chang Gung Memorial Hospital, Kaohsiung
🇨🇳Kaohsiung, Taiwan
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada
GZA Sint-Augustinus
🇧🇪Wilrijk, Belgium
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Neurological Research Center - Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Clinical Neuroscience Solutions CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Heritage Medical Research Clinic
🇨🇦Calgary, Alberta, Canada
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Memory Enhancement Center of America, Inc
🇺🇸Eatontown, New Jersey, United States
The Atlantic Neuroscience Institute
🇺🇸Springfield, New Jersey, United States
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
🇦🇺Heidelberg West, Victoria, Australia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Advanced Memory Research Institute of NJ PC
🇺🇸Toms River, New Jersey, United States
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
🇨🇦Verdun, Quebec, Canada
University Psychiatric Hospital Vrapče
🇭🇷Zagreb, Croatia
University of Eastern Finland, Brain Research Unit Mediteknia
🇫🇮Kuopio, Finland
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
🇨🇦Vancouver, British Columbia, Canada
Xenoscience, Inc / 21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
Fundació ACE
🇪🇸Barcelona, Spain
The Roskamp Institute, Inc.
🇺🇸Sarasota, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Neurostudies.net
🇺🇸Decatur, Georgia, United States
Royal Adelaide Hospital Memory Trials Centre
🇦🇺Adelaide, South Australia, Australia
Columbia University Taub Institute
🇺🇸New York, New York, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
JEM Research
🇺🇸Atlantis, Florida, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Millennium Psychiatric Associates
🇺🇸Creve Coeur, Missouri, United States
Research Foundation for Mental Hygiene, Inc.
🇺🇸Orangeburg, New York, United States
Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, United States
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
🇺🇸Cleveland, Ohio, United States
RI Hospital
🇺🇸Providence, Rhode Island, United States
University of Virginia Adult Neurology, Primary Care Center
🇺🇸Charlottesville, Virginia, United States
Division of Rehabilitation and Aged Care
🇦🇺Hornsby, New South Wales, Australia
Independent Psychiatric Consultants
🇺🇸Waukesha, Wisconsin, United States
Frontotemporal Research Group
🇦🇺Camperdown, New South Wales, Australia
McCusker Alzheimer's Research Foundation Inc
🇦🇺Nedlands, Western Australia, Australia
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Neurodegenerative Disorders Research Pty Ltd
🇦🇺Subiaco, Western Australia, Australia
Jessa Hospital
🇧🇪Hasselt, Belgium
Hospital Sultan Ismail
🇲🇾Johor Bahru, Malaysia
University Hospital Ghent Department of Neurology
🇧🇪Ghent, Belgium
University Hospital Centre Zagreb, Department of Neurology
🇭🇷Zagreb, Croatia
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
🇷🇺Ekaterinburg, Russian Federation
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Arzeneimittelforschung Leipzig GmbH
🇩🇪Leipzig, Germany
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
🇷🇺Moscow, Russian Federation
Mental Health Research Center of the Russian Academy of Medical Sciences
🇷🇺Moscow, Russian Federation
City Clinical Hospital #34, City Scientific Practical Neurological Center
🇷🇺Novosibirsk, Russian Federation
City Geriatric Medical and Social Center
🇷🇺Saint Petersburg, Russian Federation
National University Hospital (NUH)
🇸🇬Singapore, Singapore
China Medical University Hospital
🇨🇳Taichung, Taiwan
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
🇬🇧Crowborough, United Kingdom
St Margaret's Hospital Mental Health Unit
🇬🇧Epping, United Kingdom
Cognition Health Ltd.
🇬🇧London, United Kingdom
RICE - The Research Institute for the Care of Older People
🇬🇧Bath, United Kingdom
Kingshill Research Centre, Victoria Hospital
🇬🇧Swindon, United Kingdom
Mayo Clinic, Alzheimer's Disease Research Center
🇺🇸Rochester, Minnesota, United States
Hôpitaux Civils de Colmar
🇫🇷Colmar, Cedex, France
Rivus Wellness and Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Memory and Aging Centre
🇺🇸San Francisco, California, United States
Hospital of the University of Pennsylvania, Department of Neurology
🇺🇸Philadelphia, Pennsylvania, United States
Alexian Brothers Neurosciences Institute
🇺🇸Elk Grove Village, Illinois, United States
Southern Neurology Pty Limited
🇦🇺Kogarah, New South Wales, Australia
SPRI
🇺🇸Brooklyn, New York, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
CNS Healthcare, Inc
🇺🇸Jacksonville, Florida, United States
Neurological Associates of Albany, P. C.
🇺🇸Albany, New York, United States
Southern California Research, LLC
🇺🇸Fountain Valley, California, United States
Neuro-Therapeutics, Inc.
🇺🇸Pasadena, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Compass Research, LLC - North Clinic
🇺🇸The Villages, Florida, United States
ActivMed Practices & Research
🇺🇸Methuen, Massachusetts, United States
Ruan Neurology Clinic and Research Center
🇺🇸Des Moines, Iowa, United States
Neurobehavioral Clinical Research
🇺🇸Canton, Ohio, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Discipline of Psychiatry, University of Queensland
🇦🇺Herston, Queensland, Australia
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
🇨🇦London, Ontario, Canada
Centre de Recherche Clinique
🇫🇷Toulouse, France
Charité, University Medicine Berlin, CBF, Neurology
🇩🇪Berlin, Germany
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
🇷🇺Moscow, Russian Federation
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
🇷🇺Saint Petersburg, Russian Federation
Hospital Viamed Montecanal
🇪🇸Zaragoza, Spain
Grampian NHS, Royal Cornhill Hospital
🇬🇧Aberdeen, United Kingdom
Belfast Health and Social Care Trust (BHSCT)
🇬🇧Belfast, United Kingdom
The Barberry Centre
🇬🇧Birmingham, United Kingdom
MAC Clinical Research Ltd
🇬🇧Manchester, United Kingdom
Nuffield Department of Clinical Neurosciences
🇬🇧Oxford, United Kingdom
Cognition Health Ltd
🇬🇧Guildford, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
🇬🇧London, United Kingdom
Leonard Wolfson Experimental Neurology Centre
🇬🇧London, United Kingdom
Redwoods Centre
🇬🇧Shrewsbury, United Kingdom
Wessex Neurological Centre, Southampton General Hospital
🇬🇧Southampton, United Kingdom
Memory Assessment and Research Centre (MARC)
🇬🇧Southampton, United Kingdom
Collaborative Neuroscience Network
🇺🇸Long Beach, California, United States
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
University of South Florida
🇺🇸Tampa, Florida, United States
Senior Adults Specialty Research, Inc.
🇺🇸Austin, Texas, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
UNC Department of Neurology, Physicians Office Building
🇺🇸Chapel Hill, North Carolina, United States
Clinical Trials of America, Inc
🇺🇸Winston-Salem, North Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
True North Clinical Research Kentville Inc
🇨🇦Kentville, Nova Scotia, Canada