Study Stopped
This study has been terminated for administrative reasons only.
Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
1 other identifier
interventional
913
17 countries
135
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2014
Typical duration for phase_3
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 27, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
June 2, 2020
CompletedMay 24, 2023
May 1, 2023
2.8 years
August 27, 2014
May 15, 2020
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Serious or Non-serious Adverse Events
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.
Up to 34 months
Study Arms (1)
LMTM
EXPERIMENTALInterventions
The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (135)
Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, 85004, United States
Southern California Research, LLC
Fountain Valley, California, 92708, United States
Feldman, Robert MD
Laguna Hills, California, 92653, United States
Collaborative Neuroscience Network
Long Beach, California, 90806, United States
The Shankle Clinic
Newport Beach, California, 92663, United States
Neuro-Therapeutics, Inc.
Pasadena, California, 91105, United States
Pacific Research Network
San Diego, California, 92103, United States
San Francisco Clinical Research Center
San Francisco, California, 94118, United States
Memory and Aging Centre
San Francisco, California, 94158, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
JEM Research
Atlantis, Florida, 33462, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Meridien Research
Brooksville, Florida, 34601, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
MD Clinical
Hallandale, Florida, 33009, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
CNS Healthcare, Inc
Jacksonville, Florida, 32256, United States
Miami Research Associates
Miami, Florida, 33143, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
The Roskamp Institute, Inc.
Sarasota, Florida, 34243, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33613, United States
Compass Research, LLC - North Clinic
The Villages, Florida, 32162, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Neurostudies.net
Decatur, Georgia, 30033, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007, United States
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, 50314, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Mayo Clinic, Alzheimer's Disease Research Center
Rochester, Minnesota, 55905, United States
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141, United States
Memory Enhancement Center of America, Inc
Eatontown, New Jersey, 07724, United States
The Atlantic Neuroscience Institute
Springfield, New Jersey, 07801, United States
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, 08757, United States
Neurological Associates of Albany, P. C.
Albany, New York, 12208, United States
SPRI
Brooklyn, New York, 11235, United States
Columbia University Taub Institute
New York, New York, 10032, United States
Research Foundation for Mental Hygiene, Inc.
Orangeburg, New York, 10962, United States
UNC Department of Neurology, Physicians Office Building
Chapel Hill, North Carolina, 27599, United States
Clinical Trials of America, Inc
Winston-Salem, North Carolina, 27103, United States
Neurobehavioral Clinical Research
Canton, Ohio, 44718, United States
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
Cleveland, Ohio, 44106, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Hospital of the University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, 19104, United States
RI Hospital
Providence, Rhode Island, 02903, United States
Neurology Clinic, P.C.
Cordova, Tennessee, 38018, United States
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Senior Adults Specialty Research, Inc.
Austin, Texas, 78757, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
University of Virginia Adult Neurology, Primary Care Center
Charlottesville, Virginia, 22903, United States
Independent Psychiatric Consultants
Waukesha, Wisconsin, 53188, United States
Frontotemporal Research Group
Camperdown, New South Wales, 2000, Australia
Division of Rehabilitation and Aged Care
Hornsby, New South Wales, 2077, Australia
Southern Neurology Pty Limited
Kogarah, New South Wales, 2217, Australia
Discipline of Psychiatry, University of Queensland
Herston, Queensland, 4006, Australia
Royal Adelaide Hospital Memory Trials Centre
Adelaide, South Australia, 5000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
McCusker Alzheimer's Research Foundation Inc
Nedlands, Western Australia, 6009, Australia
Neurodegenerative Disorders Research Pty Ltd
Subiaco, Western Australia, 6008, Australia
University Hospital Ghent Department of Neurology
Ghent, 9000, Belgium
Jessa Hospital
Hasselt, 3500, Belgium
GZA Sint-Augustinus
Wilrijk, 2610, Belgium
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, V6T 1Z3, Canada
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8, Canada
True North Clinical Research Halifax Inc
Halifax, Nova Scotia, B3S 1M7, Canada
True North Clinical Research Kentville Inc
Kentville, Nova Scotia, B4N 4K9, Canada
Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
London, Ontario, N6C 0A7, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
Verdun, Quebec, H4H 1R3, Canada
University Hospital Centre Zagreb, Department of Neurology
Zagreb, 10000, Croatia
University Psychiatric Hospital Vrapče
Zagreb, 10090, Croatia
University of Eastern Finland, Brain Research Unit Mediteknia
Kuopio, 70210, Finland
Clinical Research Services Turku (CRST)
Turku, 20520, Finland
Hôpitaux Civils de Colmar
Colmar, Cedex, 68024, France
Centre de Recherche Clinique
Toulouse, 31059, France
Hôpital de Charpennes
Villeurbanne, 69100, France
Charité, University Medicine Berlin, CBF, Neurology
Berlin, 12200, Germany
Arzeneimittelforschung Leipzig GmbH
Leipzig, 04107, Germany
University Kuala Lumpur Royal College of Medicine
Ipoh, 30450, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
Erasmus University Medical Center
Rotterdam, 3015, Netherlands
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
Sibiu, 550082, Romania
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
Moscow, 109388, Russia
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
Moscow, 115522, Russia
Mental Health Research Center of the Russian Academy of Medical Sciences
Moscow, 115522, Russia
City Clinical Hospital #34, City Scientific Practical Neurological Center
Novosibirsk, 630054, Russia
City Geriatric Medical and Social Center
Saint Petersburg, 190103, Russia
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
Saint Petersburg, 192019, Russia
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
Yekaterinburg, 620030, Russia
National University Hospital (NUH)
Singapore, 119228, Singapore
National Neuroscience Institute (NNI)
Singapore, 308433, Singapore
Dong-A University Hospital
Busan, 602-715, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Seoul National University Boramae Medical Center
Seoul, 156-707, South Korea
Seoul National University Hospital
Seoul, South Korea
Fundació ACE
Barcelona, 08028, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Viamed Montecanal
Zaragoza, 50006, Spain
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
Grampian NHS, Royal Cornhill Hospital
Aberdeen, AB25 2ZH, United Kingdom
RICE - The Research Institute for the Care of Older People
Bath, BA1 3NG, United Kingdom
Belfast Health and Social Care Trust (BHSCT)
Belfast, BT12 6BA, United Kingdom
The Barberry Centre
Birmingham, B15 2SG, United Kingdom
MAC Clinical Research Ltd
Blackpool, FY2 0JH, United Kingdom
MAC Clinical Research Ltd
Cannock, WS11 0BN, United Kingdom
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
Crowborough, TN6 1HB, United Kingdom
St Margaret's Hospital Mental Health Unit
Epping, CM16 6TN, United Kingdom
Cognition Health Ltd
Guildford, GU27YD, United Kingdom
MAC Clinical Research Ltd
Leeds, LS10 1DU, United Kingdom
Cognition Health Ltd.
London, W1G 9JF, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF, United Kingdom
Leonard Wolfson Experimental Neurology Centre
London, WC1N 3BG, United Kingdom
MAC Clinical Research Ltd
Manchester, M13 9NQ, United Kingdom
Nuffield Department of Clinical Neurosciences
Oxford, OX3 9DU, United Kingdom
Redwoods Centre
Shrewsbury, SY3 8DS, United Kingdom
Wessex Neurological Centre, Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Memory Assessment and Research Centre (MARC)
Southampton, SO30 3JB, United Kingdom
Kingshill Research Centre, Victoria Hospital
Swindon, SN3 6BW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Diane Downie
- Organization
- TauRx Therapeutics Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 27, 2014
First Posted
September 19, 2014
Study Start
August 1, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 24, 2023
Results First Posted
June 2, 2020
Record last verified: 2023-05