Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

May 22, 2023 updated by: TauRx Therapeutics Ltd

An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

913

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2000
        • Frontotemporal Research Group
      • Hornsby, New South Wales, Australia, 2077
        • Division of Rehabilitation and Aged Care
      • Kogarah, New South Wales, Australia, 2217
        • Southern Neurology Pty Limited
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Discipline of Psychiatry, University of Queensland
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital Memory Trials Centre
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Heidelberg West, Victoria, Australia, 3081
        • Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • McCusker Alzheimer's Research Foundation Inc
      • Subiaco, Western Australia, Australia, 6008
        • Neurodegenerative Disorders Research Pty Ltd
  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent Department of Neurology
      • Hasselt, Belgium, 3500
        • Jessa Hospital
      • Wilrijk, Belgium, 2610
        • GZA Sint-Augustinus
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Heritage Medical Research Clinic
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
      • Victoria, British Columbia, Canada, V8R 1J8
        • Vancouver Island Health Authority
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • True North Clinical Research Halifax Inc
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • True North Clinical Research Kentville Inc
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Verdun, Quebec, Canada, H4H 1R3
        • McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb, Department of Neurology
      • Zagreb, Croatia, 10090
        • University Psychiatric Hospital Vrapce
  • Finland
      • Kuopio, Finland, 70210
        • University of Eastern Finland, Brain Research Unit Mediteknia
      • Turku, Finland, 20520
        • Clinical Research Services Turku (CRST)
  • France
      • Toulouse, France, 31059
        • Centre de Recherche Clinique
      • Villeurbanne, France, 69100
        • Hôpital de Charpennes
    • Cedex
      • Colmar, Cedex, France, 68024
        • Hôpitaux Civils de Colmar
  • Germany
      • Berlin, Germany, 12200
        • Charité, University Medicine Berlin, CBF, Neurology
      • Leipzig, Germany, 04107
        • Arzeneimittelforschung Leipzig GmbH
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 156-707
        • Seoul National University Boramae Medical Center
  • Malaysia
      • Ipoh, Malaysia, 30450
        • University Kuala Lumpur Royal College of Medicine
      • Johor Bahru, Malaysia, 81100
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malaysia, 50603
        • University Malaya Medical Centre
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus University Medical Center
  • Romania
      • Sibiu, Romania, 550082
        • Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620030
        • State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
      • Moscow, Russian Federation, 109388
        • Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
      • Moscow, Russian Federation, 115522
        • Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
      • Moscow, Russian Federation, 115522
        • Mental Health Research Center of the Russian Academy of Medical Sciences
      • Novosibirsk, Russian Federation, 630054
        • City Clinical Hospital #34, City Scientific Practical Neurological Center
      • Saint Petersburg, Russian Federation, 190103
        • City Geriatric Medical and Social Center
      • Saint Petersburg, Russian Federation, 192019
        • Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital (NUH)
      • Singapore, Singapore, 308433
        • National Neuroscience Institute (NNI)
  • Spain
      • Barcelona, Spain, 08028
        • Fundacio ACE
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Zaragoza, Spain, 50006
        • Hospital Viamed Montecanal
  • Taiwan
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital, Kaohsiung
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital, Linkou
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZH
        • Grampian NHS, Royal Cornhill Hospital
      • Bath, United Kingdom, BA1 3NG
        • RICE - The Research Institute for the Care of Older People
      • Belfast, United Kingdom, BT12 6BA
        • Belfast Health and Social Care Trust (BHSCT)
      • Birmingham, United Kingdom, B15 2SG
        • The Barberry Centre
      • Blackpool, United Kingdom, FY2 0JH
        • MAC Clinical Research Ltd
      • Cannock, United Kingdom, WS11 0BN
        • MAC Clinical Research Ltd
      • Crowborough, United Kingdom, TN6 1HB
        • Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
      • Epping, United Kingdom, CM16 6TN
        • St Margaret's Hospital Mental Health Unit
      • Guildford, United Kingdom, GU27YD
        • Cognition Health Ltd
      • Leeds, United Kingdom, LS10 1DU
        • MAC Clinical Research Ltd
      • London, United Kingdom, WC1N 3BG
        • Leonard Wolfson Experimental Neurology Centre
      • London, United Kingdom, W1G 9JF
        • Cognition Health Ltd.
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust - Charing Cross Hospital
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research Ltd
      • Oxford, United Kingdom, OX3 9DU
        • Nuffield Department of Clinical Neurosciences
      • Shrewsbury, United Kingdom, SY3 8DS
        • Redwoods Centre
      • Southampton, United Kingdom, SO16 6YD
        • Wessex Neurological Centre, Southampton General Hospital
      • Southampton, United Kingdom, SO30 3JB
        • Memory Assessment and Research Centre (MARC)
      • Swindon, United Kingdom, SN3 6BW
        • Kingshill Research Centre, Victoria Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Xenoscience, Inc / 21st Century Neurology
    • California
      • Fountain Valley, California, United States, 92708
        • Southern California Research, LLC
      • Laguna Hills, California, United States, 92653
        • Feldman, Robert MD
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network
      • Newport Beach, California, United States, 92663
        • The Shankle Clinic
      • Pasadena, California, United States, 91105
        • Neuro-Therapeutics, Inc.
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Francisco, California, United States, 94118
        • San Francisco Clinical Research Center
      • San Francisco, California, United States, 94158
        • Memory and Aging Centre
      • Sherman Oaks, California, United States, 91403
        • Schuster Medical Research Institute
    • Colorado
      • Denver, Colorado, United States, 80218
        • Mile High Research Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research, LLC
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32256
        • CNS Healthcare, Inc
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Sarasota, Florida, United States, 34243
        • The Roskamp Institute, Inc.
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, United States, 33613
        • University of South Florida
      • The Villages, Florida, United States, 32162
        • Compass Research, LLC - North Clinic
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta
      • Decatur, Georgia, United States, 30033
        • Neurostudies.net
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neurosciences Institute
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Ruan Neurology Clinic and Research Center
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Alzheimer's Disease Research Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Neurological Research Center - Hattiesburg Clinic
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Millennium Psychiatric Associates
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center of America, Inc
      • Springfield, New Jersey, United States, 07801
        • The Atlantic Neuroscience Institute
      • Toms River, New Jersey, United States, 08757
        • Advanced Memory Research Institute of NJ PC
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany, P. C.
      • Brooklyn, New York, United States, 11235
        • SPRI
      • New York, New York, United States, 10032
        • Columbia University Taub Institute
      • Orangeburg, New York, United States, 10962
        • Research Foundation for Mental Hygiene, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Department of Neurology, Physicians Office Building
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Trials of America, Inc
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neurobehavioral Clinical Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center, Neurology Clinical Trials Unit
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Rivus Wellness and Research Institute
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania, Department of Neurology
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • RI Hospital
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic, P.C.
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions CNS Healthcare
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research, Inc.
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Adult Neurology, Primary Care Center
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Independent Psychiatric Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LMTM
Drug: LMTM
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious or Non-serious Adverse Events
Time Frame: 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.
Up to 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TauRx Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRx-237-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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