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Open-Label Study of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02245568
Recruitment Status : Terminated
First Posted : September 19, 2014
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Brief Summary:
The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term safety of TRx0237.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral Variant Frontotemporal Dementia Drug: TRx0237 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 913 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Extension Study of the Effects of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Study Start Date : August 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


Arm Intervention/treatment
Experimental: TRx0237 Drug: TRx0237
All subjects will initially be given 200 mg/day of TRx0237 (one 100-mg tablet in the morning and one 100-mg tablet in the evening). Thereafter, dosing is flexible (100 mg/day to 300 mg/day).




Primary Outcome Measures :
  1. Number of participants with serious and non-serious adverse events [ Time Frame: Up to 34 months ]
  2. Change from Baseline in laboratory test values [ Time Frame: Up to 34 months ]
    Standard hematology and serum chemistry parameters to be measured

  3. Change from Baseline in vital signs [ Time Frame: Up to 34 months ]
    Vital signs to be measured include blood pressure and pulse, temperature, respiratory rate and weight

  4. Change from Baseline in electrocardiograms [ Time Frame: Up to 34 months ]

Other Outcome Measures:
  1. Score of Euro Quality of Life - 5-level version (EQ-5D-5L) [ Time Frame: Up to 34 months ]
  2. Score of Resource Utilization in Dementia Questionnaire-Lite (RUD-Lite) [ Time Frame: Up to 34 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245568


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Locations
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United States, Arizona
Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, United States, 85004
United States, California
Southern California Research, LLC
Fountain Valley, California, United States, 92708
Feldman, Robert MD
Laguna Hills, California, United States, 92653
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
The Shankle Clinic
Newport Beach, California, United States, 92663
Neuro-Therapeutics, Inc.
Pasadena, California, United States, 91105
Pacific Research Network
San Diego, California, United States, 92103
San Francisco Clinical Research Center
San Francisco, California, United States, 94118
Memory and Aging Centre
San Francisco, California, United States, 94158
Neurological Research Institute
Santa Monica, California, United States, 90404
Schuster Medical Research Institute
Sherman Oaks, California, United States, 91403
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Coastal Connecticut Research, LLC
New London, Connecticut, United States, 06320
United States, Florida
JEM Research
Atlantis, Florida, United States, 33462
Bradenton Research Center
Bradenton, Florida, United States, 34205
Meridien Research
Brooksville, Florida, United States, 34601
Brain Matters Research
Delray Beach, Florida, United States, 33445
MD Clinical
Hallandale Beach, Florida, United States, 33009
Mayo Clinic
Jacksonville, Florida, United States, 32224
CNS Healthcare, Inc
Jacksonville, Florida, United States, 32256
Miami Research Associates
Miami, Florida, United States, 33143
Compass Research, LLC
Orlando, Florida, United States, 32806
The Roskamp Institute, Inc.
Sarasota, Florida, United States, 34243
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
University of South Florida
Tampa, Florida, United States, 33613
Compass Research, LLC - North Clinic
The Villages, Florida, United States, 32162
United States, Georgia
iResearch Atlanta
Decatur, Georgia, United States, 30030
Neurostudies.net
Decatur, Georgia, United States, 30033
United States, Illinois
Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States, 60007
United States, Iowa
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States, 50314
United States, Massachusetts
ActivMed Practices & Research
Methuen, Massachusetts, United States, 01844
United States, Minnesota
Mayo Clinic, Alzheimer's Disease Research Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Memory Enhancement Center of America, Inc
Eatontown, New Jersey, United States, 07724
The Atlantic Neuroscience Institute
Springfield, New Jersey, United States, 07801
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, United States, 08757
United States, New York
Neurological Associates of Albany, P. C.
Albany, New York, United States, 12208
SPRI
Brooklyn, New York, United States, 11235
Columbia University Taub Institute
New York, New York, United States, 10032
Research Foundation for Mental Hygiene, Inc.
Orangeburg, New York, United States, 10962
United States, North Carolina
UNC Department of Neurology, Physicians Office Building
Chapel Hill, North Carolina, United States, 27599
Clinical Trials of America, Inc
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Neurobehavioral Clinical Research
Canton, Ohio, United States, 44718
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Rivers Wellness and Research Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Hospital of the University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
RI Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Neurology Clinic, P.C.
Cordova, Tennessee, United States, 38018
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, United States, 38119
United States, Texas
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Senior Adults Specialty Research, Inc.
Austin, Texas, United States, 78757
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
United States, Wisconsin
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States, 53188
Australia, New South Wales
Division of Rehabilitation and Aged Care
Hornsby, New South Wales, Australia, 2077
Southern Neurology Pty Limited
Kogarah, New South Wales, Australia, 2217
Neuroscience Research Australia
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Discipline of Psychiatry, University of Queensland
Herston, Queensland, Australia, 4006
Australia, South Australia
Royal Adelaide Hospital Memory Trials Centre
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
McCusker Alzheimer's Research Foundation Inc
Nedlands, Western Australia, Australia, 6009
Neurodegenerative Disorders Research Pty Ltd
Subiaco, Western Australia, Australia, 6008
Belgium
Hospital Brussels Department of Neurology
Bruxelles, Belgium, 1090
University Hospital Ghent Department of Neurology
Ghent, Belgium, 9000
Jessa Hospital
Hasselt, Belgium, 3500
GZA Sint-Augustinus
Wilrijk, Belgium, 2610
Canada, Alberta
Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y 1Z9
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, Canada, V6T 2B5
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
True North Clinical Research
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville Inc
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
London, Ontario, Canada, N6C 0A7
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
Verdun, Quebec, Canada, H4H 1R3
Croatia
University Hospital Centre Zagreb, Department of Neurology
Zagreb, Croatia, 10000
University Psychiatric Hospital Vrapče
Zagreb, Croatia, 10090
Finland
University of Eastern Finland, Brain Research Unit Mediteknia
Kuopio, Finland, 70210
Clinical Research Services Turku (CRST)
Turku, Finland, 20520
France
Hôpitaux Civils de Colmar
Colmar Cedex, France, 68024
Hôpital La Grave
Toulouse, France, 31059
Hôpital de Charpennes
Villeurbanne, France, 69100
Germany
Charité, University Medicine Berlin, CBF, Neurology
Berlin, Germany, 12200
Arzeneimittelforschung Leipzig GmbH
Leipzig, Germany, 04107
Korea, Republic of
Dong-A Medical Center
Busan, Korea, Republic of, 602-715
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Seoul National University Hospital
Seoul, Korea, Republic of
Malaysia
University Kuala Lumpur Royal College of Medicine
Ipoh, Malaysia, 30450
Hospital Sultan Ismail
Johor Bahru, Malaysia, 81100
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
Netherlands
Alzheimer Research Center Amsterdam
Amsterdam, Netherlands, 1081
Erasmus University Medical Center
Rotterdam, Netherlands, 3015
Russian Federation
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
Ekaterinburg, Russian Federation, 620030
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
Moscow, Russian Federation, 109388
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
Moscow, Russian Federation, 115522
City Clinical Hospital #34, City Scientific Practical Neurological Center
Novosibirsk, Russian Federation, 630054
City Geriatric Medical and Social Center
Saint Petersburg, Russian Federation, 190103
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
Saint Petersburg, Russian Federation, 192019
Singapore
National University Hospital (NUH)
Singapore, Singapore, 119228
National Neuroscience Institute (NNI)
Singapore, Singapore, 308433
Spain
Fundació ACE
Barcelona, Spain, 08028
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Viamed Montecanal
Zaragoza, Spain, 50006
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, Taiwan
United Kingdom
NHS Grampian, OAP Directorate
Aberdeen, United Kingdom, AB25 2ZH
RICE - The Research Institute for the Care of Older People
Bath, United Kingdom, BA1 3NG
Belfast Health and Social Care Trust (BHSCT)
Belfast, United Kingdom, BT12 6BA
The Barberry Centre
Birmingham, United Kingdom, B15 2SG
MAC Clinical Research Ltd
Blackpool, United Kingdom, FY2 0JH
MAC Clinical Research Ltd
Cannock, United Kingdom, WS11 0BN
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
Crowborough, United Kingdom, TN6 1HB
St Margaret's Hospital Mental Health Unit
Epping, United Kingdom, CM16 6TN
Cognition Health Ltd
Guildford, United Kingdom, GU27YD
MAC Clinical Research Ltd
Leeds, United Kingdom, LS10 1DU
Cognition Health Ltd.
London, United Kingdom, W1G 9JF
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, United Kingdom, W6 8RF
Leonard Watson Experimental Neurology Centre
London, United Kingdom, WC1N 3BG
MAC Clinical Research Ltd
Manchester, United Kingdom, M13 9NQ
Nuffield Department of Clinical Neurosciences
Oxford, United Kingdom, OX3 9DU
Redwoods Centre
Shrewsbury, United Kingdom, SY3 5DS
Wessex Neurological Centre, Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Memory Assessment and Research Centre (MARC)
Southampton, United Kingdom, SO30 3JB
Kingshill Research Centre, Victoria Hospital
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
TauRx Therapeutics Ltd

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Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT02245568     History of Changes
Other Study ID Numbers: TRx-237-020
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by TauRx Therapeutics Ltd:
Dementia
Alzheimer Disease
bvFTD
Frontotemporal Dementia
Neurodegenerative Diseases
Brain Diseases
Cognitive Disorders

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action