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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02245568
• Other study ID #: TRx-237-020
• Status: Terminated
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2023
• Source: TauRx Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 913
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Aphasia, Primary Progressive
• Behavioral Variant Frontotemporal Dementia
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TauRx Therapeutics Ltd

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Croatia,  Finland,  France,  Germany,  Korea, Republic of,  Malaysia,  Netherlands,  Romania,  Russian Federation,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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