Clinical trial NCT02245568: Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Official title: An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Behavioral Variant Frontotemporal Dementia
Keywords: Dementia
Alzheimer Disease
bvFTD
Frontotemporal Dementia
Neurodegenerative Diseases
Brain Diseases
Cognitive Disorders
Lead sponsor: TauRx Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 913
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Serious or Non-serious Adverse Events
timeFrame: Up to 34 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc / 21st Century Neurology
state: Arizona
city: Fountain Valley
country: United States
facility: Southern California Research, LLC
state: California
city: Laguna Hills
country: United States
facility: Feldman, Robert MD
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Newport Beach
country: United States
facility: The Shankle Clinic
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: San Francisco
country: United States
facility: Memory and Aging Centre
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare, Inc
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute, Inc.
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: The Villages
country: United States
facility: Compass Research, LLC - North Clinic
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Decatur
country: United States
facility: Neurostudies.net
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosciences Institute
state: Illinois
city: Des Moines
country: United States
facility: Ruan Neurology Clinic and Research Center
state: Iowa
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic, Alzheimer's Disease Research Center
state: Minnesota
city: Hattiesburg
country: United States
facility: Neurological Research Center - Hattiesburg Clinic
state: Mississippi
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates
state: Missouri
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc
state: New Jersey
city: Springfield
country: United States
facility: The Atlantic Neuroscience Institute
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ PC
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany, P. C.
state: New York
city: Brooklyn
country: United States
facility: SPRI
state: New York
city: New York
country: United States
facility: Columbia University Taub Institute
state: New York
city: Orangeburg
country: United States
facility: Research Foundation for Mental Hygiene, Inc.
state: New York
city: Chapel Hill
country: United States
facility: UNC Department of Neurology, Physicians Office Building
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America, Inc
state: North Carolina
city: Canton
country: United States
facility: Neurobehavioral Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center, Neurology Clinical Trials Unit
state: Ohio
city: Oklahoma City
country: United States
facility: Rivus Wellness and Research Institute
state: Oklahoma
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania, Department of Neurology
state: Pennsylvania
city: Providence
country: United States
facility: RI Hospital
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic, P.C.
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Senior Adults Specialty Research, Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Adult Neurology, Primary Care Center
state: Virginia
city: Waukesha
country: United States
facility: Independent Psychiatric Consultants
state: Wisconsin
city: Camperdown
country: Australia
facility: Frontotemporal Research Group
state: New South Wales
city: Hornsby
country: Australia
facility: Division of Rehabilitation and Aged Care
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology Pty Limited
state: New South Wales
city: Herston
country: Australia
facility: Discipline of Psychiatry, University of Queensland
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Memory Trials Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Heidelberg West
country: Australia
facility: Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
state: Victoria
city: Nedlands
country: Australia
facility: McCusker Alzheimer's Research Foundation Inc
state: Western Australia
city: Subiaco
country: Australia
facility: Neurodegenerative Disorders Research Pty Ltd
state: Western Australia
city: Ghent
country: Belgium
facility: University Hospital Ghent Department of Neurology
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Wilrijk
country: Belgium
facility: GZA Sint-Augustinus
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic
state: Alberta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Halifax Inc
state: Nova Scotia
city: Kentville
country: Canada
facility: True North Clinical Research Kentville Inc
state: Nova Scotia
city: London
country: Canada
facility: Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Verdun
country: Canada
facility: McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
state: Quebec
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb, Department of Neurology
city: Zagreb
country: Croatia
facility: University Psychiatric Hospital Vrapče
city: Kuopio
country: Finland
facility: University of Eastern Finland, Brain Research Unit Mediteknia
city: Turku
country: Finland
facility: Clinical Research Services Turku (CRST)
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
state: Cedex
city: Toulouse
country: France
facility: Centre de Recherche Clinique
city: Villeurbanne
country: France
facility: Hôpital de Charpennes
city: Berlin
country: Germany
facility: Charité, University Medicine Berlin, CBF, Neurology
city: Leipzig
country: Germany
facility: Arzeneimittelforschung Leipzig GmbH
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ipoh
country: Malaysia
facility: University Kuala Lumpur Royal College of Medicine
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Sibiu
country: Romania
facility: Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
city: Moscow
country: Russian Federation
facility: Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
city: Moscow
country: Russian Federation
facility: Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
city: Moscow
country: Russian Federation
facility: Mental Health Research Center of the Russian Academy of Medical Sciences
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #34, City Scientific Practical Neurological Center
city: Saint Petersburg
country: Russian Federation
facility: City Geriatric Medical and Social Center
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
city: Singapore
country: Singapore
facility: National University Hospital (NUH)
city: Singapore
country: Singapore
facility: National Neuroscience Institute (NNI)
city: Barcelona
country: Spain
facility: Fundació ACE
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Aberdeen
country: United Kingdom
facility: Grampian NHS, Royal Cornhill Hospital
city: Bath
country: United Kingdom
facility: RICE - The Research Institute for the Care of Older People
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust (BHSCT)
city: Birmingham
country: United Kingdom
facility: The Barberry Centre
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research Ltd
city: Cannock
country: United Kingdom
facility: MAC Clinical Research Ltd
city: Crowborough
country: United Kingdom
facility: Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
city: Epping
country: United Kingdom
facility: St Margaret's Hospital Mental Health Unit
city: Guildford
country: United Kingdom
facility: Cognition Health Ltd
city: Leeds
country: United Kingdom
facility: MAC Clinical Research Ltd
city: London
country: United Kingdom
facility: Cognition Health Ltd.
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital
city: London
country: United Kingdom
facility: Leonard Wolfson Experimental Neurology Centre
city: Manchester
country: United Kingdom
facility: MAC Clinical Research Ltd
city: Oxford
country: United Kingdom
facility: Nuffield Department of Clinical Neurosciences
city: Shrewsbury
country: United Kingdom
facility: Redwoods Centre
city: Southampton
country: United Kingdom
facility: Wessex Neurological Centre, Southampton General Hospital
city: Southampton
country: United Kingdom
facility: Memory Assessment and Research Centre (MARC)
city: Swindon
country: United Kingdom
facility: Kingshill Research Centre, Victoria Hospital
Study officials:
References: