Back to resultsOpen-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Primary Purpose
Alzheimer's Disease, Behavioral Variant Frontotemporal Dementia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LMTM
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dementia, Alzheimer Disease, bvFTD, Frontotemporal Dementia, Neurodegenerative Diseases, Brain Diseases, Cognitive Disorders
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
Sites / Locations
- Xenoscience, Inc / 21st Century Neurology
- Southern California Research, LLC
- Feldman, Robert MD
- Collaborative Neuroscience Network
- The Shankle Clinic
- Neuro-Therapeutics, Inc.
- Pacific Research Network
- San Francisco Clinical Research Center
- Memory and Aging Centre
- Schuster Medical Research Institute
- Mile High Research Center
- Institute for Neurodegenerative Disorders
- Yale University School of Medicine
- Coastal Connecticut Research, LLC
- JEM Research
- Bradenton Research Center
- Meridien Research
- Brain Matters Research
- MD Clinical
- Mayo Clinic
- CNS Healthcare, Inc
- Miami Research Associates
- Compass Research, LLC
- The Roskamp Institute, Inc.
- Axiom Clinical Research of Florida
- University of South Florida
- Compass Research, LLC - North Clinic
- iResearch Atlanta
- Neurostudies.net
- Alexian Brothers Neurosciences Institute
- Ruan Neurology Clinic and Research Center
- ActivMed Practices & Research
- Mayo Clinic, Alzheimer's Disease Research Center
- Neurological Research Center - Hattiesburg Clinic
- Millennium Psychiatric Associates
- Memory Enhancement Center of America, Inc
- The Atlantic Neuroscience Institute
- Advanced Memory Research Institute of NJ PC
- Neurological Associates of Albany, P. C.
- SPRI
- Columbia University Taub Institute
- Research Foundation for Mental Hygiene, Inc.
- UNC Department of Neurology, Physicians Office Building
- Clinical Trials of America, Inc
- Neurobehavioral Clinical Research
- University Hospitals Case Medical Center, Neurology Clinical Trials Unit
- Rivus Wellness and Research Institute
- The Clinical Trial Center, LLC
- Hospital of the University of Pennsylvania, Department of Neurology
- RI Hospital
- Neurology Clinic, P.C.
- Clinical Neuroscience Solutions CNS Healthcare
- FutureSearch Trials of Neurology
- Senior Adults Specialty Research, Inc.
- FutureSearch Trials of Dallas, LP
- University of Virginia Adult Neurology, Primary Care Center
- Independent Psychiatric Consultants
- Frontotemporal Research Group
- Division of Rehabilitation and Aged Care
- Southern Neurology Pty Limited
- Discipline of Psychiatry, University of Queensland
- Royal Adelaide Hospital Memory Trials Centre
- Box Hill Hospital
- Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
- McCusker Alzheimer's Research Foundation Inc
- Neurodegenerative Disorders Research Pty Ltd
- University Hospital Ghent Department of Neurology
- Jessa Hospital
- GZA Sint-Augustinus
- Heritage Medical Research Clinic
- Okanagan Clinical Trials
- University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
- Vancouver Island Health Authority
- True North Clinical Research Halifax Inc
- True North Clinical Research Kentville Inc
- Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
- Toronto Memory Program
- Jewish General Hospital
- McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
- University Hospital Centre Zagreb, Department of Neurology
- University Psychiatric Hospital Vrapče
- University of Eastern Finland, Brain Research Unit Mediteknia
- Clinical Research Services Turku (CRST)
- Hôpitaux Civils de Colmar
- Centre de Recherche Clinique
- Hôpital de Charpennes
- Charité, University Medicine Berlin, CBF, Neurology
- Arzeneimittelforschung Leipzig GmbH
- Dong-A University Hospital
- Gachon University Gil Medical Center
- Samsung Medical Center
- Seoul National University Boramae Medical Center
- Seoul National University Hospital
- University Kuala Lumpur Royal College of Medicine
- Hospital Sultan Ismail
- University Malaya Medical Centre
- Erasmus University Medical Center
- Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
- State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
- Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
- Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
- Mental Health Research Center of the Russian Academy of Medical Sciences
- City Clinical Hospital #34, City Scientific Practical Neurological Center
- City Geriatric Medical and Social Center
- Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
- National University Hospital (NUH)
- National Neuroscience Institute (NNI)
- Fundació ACE
- Hospital Clinico San Carlos
- Hospital Universitario La Paz
- Hospital Viamed Montecanal
- Chang Gung Memorial Hospital, Kaohsiung
- China Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital, Linkou
- Grampian NHS, Royal Cornhill Hospital
- RICE - The Research Institute for the Care of Older People
- Belfast Health and Social Care Trust (BHSCT)
- The Barberry Centre
- MAC Clinical Research Ltd
- MAC Clinical Research Ltd
- Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
- St Margaret's Hospital Mental Health Unit
- Cognition Health Ltd
- MAC Clinical Research Ltd
- Cognition Health Ltd.
- Imperial College Healthcare NHS Trust - Charing Cross Hospital
- Leonard Wolfson Experimental Neurology Centre
- MAC Clinical Research Ltd
- Nuffield Department of Clinical Neurosciences
- Redwoods Centre
- Wessex Neurological Centre, Southampton General Hospital
- Memory Assessment and Research Centre (MARC)
- Kingshill Research Centre, Victoria Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LMTM
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02245568
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
This study has been terminated for administrative reasons only.
Study Start Date
August 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TauRx Therapeutics Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Behavioral Variant Frontotemporal Dementia
Keywords
Dementia, Alzheimer Disease, bvFTD, Frontotemporal Dementia, Neurodegenerative Diseases, Brain Diseases, Cognitive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
913 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LMTM
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LMTM
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants With Serious or Non-serious Adverse Events
Description
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.
Time Frame
Up to 34 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Xenoscience, Inc / 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Southern California Research, LLC
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Feldman, Robert MD
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
The Shankle Clinic
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Neuro-Therapeutics, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Memory and Aging Centre
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
JEM Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CNS Healthcare, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Roskamp Institute, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Compass Research, LLC - North Clinic
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Neurostudies.net
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Ruan Neurology Clinic and Research Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Mayo Clinic, Alzheimer's Disease Research Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Neurological Research Center - Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Millennium Psychiatric Associates
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Memory Enhancement Center of America, Inc
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
The Atlantic Neuroscience Institute
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07801
Country
United States
Facility Name
Advanced Memory Research Institute of NJ PC
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08757
Country
United States
Facility Name
Neurological Associates of Albany, P. C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
SPRI
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Columbia University Taub Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
UNC Department of Neurology, Physicians Office Building
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Clinical Trials of America, Inc
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Neurobehavioral Clinical Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Rivus Wellness and Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Hospital of the University of Pennsylvania, Department of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
RI Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Clinical Neuroscience Solutions CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Senior Adults Specialty Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Virginia Adult Neurology, Primary Care Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Independent Psychiatric Consultants
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Frontotemporal Research Group
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Division of Rehabilitation and Aged Care
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Southern Neurology Pty Limited
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Discipline of Psychiatry, University of Queensland
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Royal Adelaide Hospital Memory Trials Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
McCusker Alzheimer's Research Foundation Inc
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Neurodegenerative Disorders Research Pty Ltd
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
University Hospital Ghent Department of Neurology
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
GZA Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Vancouver Island Health Authority
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
True North Clinical Research Halifax Inc
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
True North Clinical Research Kentville Inc
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
University Hospital Centre Zagreb, Department of Neurology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Psychiatric Hospital Vrapče
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
University of Eastern Finland, Brain Research Unit Mediteknia
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Clinical Research Services Turku (CRST)
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
State/Province
Cedex
ZIP/Postal Code
68024
Country
France
Facility Name
Centre de Recherche Clinique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital de Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Charité, University Medicine Berlin, CBF, Neurology
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Arzeneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
University Kuala Lumpur Royal College of Medicine
City
Ipoh
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
Facility Name
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
City
Moscow
ZIP/Postal Code
109388
Country
Russian Federation
Facility Name
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Mental Health Research Center of the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
City Clinical Hospital #34, City Scientific Practical Neurological Center
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
City Geriatric Medical and Social Center
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
National University Hospital (NUH)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Neuroscience Institute (NNI)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Fundació ACE
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
ZIP/Postal Code
50006
Country
Spain
Facility Name
Chang Gung Memorial Hospital, Kaohsiung
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan
Facility Name
Grampian NHS, Royal Cornhill Hospital
City
Aberdeen
ZIP/Postal Code
AB25 2ZH
Country
United Kingdom
Facility Name
RICE - The Research Institute for the Care of Older People
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust (BHSCT)
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
The Barberry Centre
City
Birmingham
ZIP/Postal Code
B15 2SG
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Cannock
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
City
Crowborough
ZIP/Postal Code
TN6 1HB
Country
United Kingdom
Facility Name
St Margaret's Hospital Mental Health Unit
City
Epping
ZIP/Postal Code
CM16 6TN
Country
United Kingdom
Facility Name
Cognition Health Ltd
City
Guildford
ZIP/Postal Code
GU27YD
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Leeds
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Facility Name
Cognition Health Ltd.
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust - Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Leonard Wolfson Experimental Neurology Centre
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Nuffield Department of Clinical Neurosciences
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Redwoods Centre
City
Shrewsbury
ZIP/Postal Code
SY3 8DS
Country
United Kingdom
Facility Name
Wessex Neurological Centre, Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Memory Assessment and Research Centre (MARC)
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Facility Name
Kingshill Research Centre, Victoria Hospital
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
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