Alzheimer's DiseasePhase 3NCT02245568
Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
A Phase 3 study testing LMTM in people with Alzheimer's Disease and Behavioral Variant Frontotemporal Dementia, run by TauRx Therapeutics Ltd at 135 sites in 17 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease, Behavioral Variant Frontotemporal Dementia
- What is being tested?
- LMTM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 913 participants
- Where
- 135 sitesin 17 countries
- Study dates
- Aug 2014to May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
135 sites in 17 countries.
135 sites in 17 countries
United States57 sites
Neurological Associates of Albany, P. C.
Albany, New York, 12208
JEM Research
Atlantis, Florida, 33462
FutureSearch Trials of Neurology
Austin, Texas, 78731
Senior Adults Specialty Research, Inc.
Austin, Texas, 78757
Bradenton Research Center
Bradenton, Florida, 34205
SPRI
Brooklyn, New York, 11235
Meridien Research
Brooksville, Florida, 34601
Neurobehavioral Clinical Research
Canton, Ohio, 44718
UNC Department of Neurology, Physicians Office Building
Chapel Hill, North Carolina, 27599
University of Virginia Adult Neurology, Primary Care Center
Charlottesville, Virginia, 22903
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
Cleveland, Ohio, 44106
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
iResearch Atlanta
Decatur, Georgia, 30030
Neurostudies.net
Decatur, Georgia, 30033
Brain Matters Research
Delray Beach, Florida, 33445
Mile High Research Center
Denver, Colorado, 80218
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, 50314
Memory Enhancement Center of America, Inc
Eatontown, New Jersey, 07724
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007
Southern California Research, LLC
Fountain Valley, California, 92708
MD Clinical
Hallandale, Florida, 33009
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Mayo Clinic
Jacksonville, Florida, 32224
CNS Healthcare, Inc
Jacksonville, Florida, 32256
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Feldman, Robert MD
Laguna Hills, California, 92653
Collaborative Neuroscience Network
Long Beach, California, 90806
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, 38119
ActivMed Practices & Research
Methuen, Massachusetts, 01844
Miami Research Associates
Miami, Florida, 33143
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Yale University School of Medicine
New Haven, Connecticut, 06510
Coastal Connecticut Research, LLC
New London, Connecticut, 06320
Columbia University Taub Institute
New York, New York, 10032
The Shankle Clinic
Newport Beach, California, 92663
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112
Research Foundation for Mental Hygiene, Inc.
Orangeburg, New York, 10962
Compass Research, LLC
Orlando, Florida, 32806
Neuro-Therapeutics, Inc.
Pasadena, California, 91105
Hospital of the University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, 19104
Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, 85004
RI Hospital
Providence, Rhode Island, 02903
Mayo Clinic, Alzheimer's Disease Research Center
Rochester, Minnesota, 55905
Pacific Research Network
San Diego, California, 92103
San Francisco Clinical Research Center
San Francisco, California, 94118
Memory and Aging Centre
San Francisco, California, 94158
The Roskamp Institute, Inc.
Sarasota, Florida, 34243
Schuster Medical Research Institute
Sherman Oaks, California, 91403
The Atlantic Neuroscience Institute
Springfield, New Jersey, 07801
Axiom Clinical Research of Florida
Tampa, Florida, 33609
University of South Florida
Tampa, Florida, 33613
Compass Research, LLC - North Clinic
The Villages, Florida, 32162
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, 08757
Independent Psychiatric Consultants
Waukesha, Wisconsin, 53188
Clinical Trials of America, Inc
Winston-Salem, North Carolina, 27103
United Kingdom19 sites
Grampian NHS, Royal Cornhill Hospital
Aberdeen, AB25 2ZH
RICE - The Research Institute for the Care of Older People
Bath, BA1 3NG
Belfast Health and Social Care Trust (BHSCT)
Belfast, BT12 6BA
The Barberry Centre
Birmingham, B15 2SG
MAC Clinical Research Ltd
Blackpool, FY2 0JH
MAC Clinical Research Ltd
Cannock, WS11 0BN
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
Crowborough, TN6 1HB
St Margaret's Hospital Mental Health Unit
Epping, CM16 6TN
Cognition Health Ltd
Guildford, GU27YD
MAC Clinical Research Ltd
Leeds, LS10 1DU
Cognition Health Ltd.
London, W1G 9JF
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF
Leonard Wolfson Experimental Neurology Centre
London, WC1N 3BG
MAC Clinical Research Ltd
Manchester, M13 9NQ
Nuffield Department of Clinical Neurosciences
Oxford, OX3 9DU
Redwoods Centre
Shrewsbury, SY3 8DS
Wessex Neurological Centre, Southampton General Hospital
Southampton, SO16 6YD
Memory Assessment and Research Centre (MARC)
Southampton, SO30 3JB
Kingshill Research Centre, Victoria Hospital
Swindon, SN3 6BW
Canada10 sites
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6
True North Clinical Research Halifax Inc
Halifax, Nova Scotia, B3S 1M7
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9
True North Clinical Research Kentville Inc
Kentville, Nova Scotia, B4N 4K9
Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
London, Ontario, N6C 0A7
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Toronto Memory Program
Toronto, Ontario, M3B 2S7
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, V6T 1Z3
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
Verdun, Quebec, H4H 1R3
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8
Australia9 sites
Royal Adelaide Hospital Memory Trials Centre
Adelaide, South Australia, 5000
Box Hill Hospital
Box Hill, Victoria, 3128
Frontotemporal Research Group
Camperdown, New South Wales, 2000
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
Heidelberg West, Victoria, 3081
Discipline of Psychiatry, University of Queensland
Herston, Queensland, 4006
Division of Rehabilitation and Aged Care
Hornsby, New South Wales, 2077
Southern Neurology Pty Limited
Kogarah, New South Wales, 2217
McCusker Alzheimer's Research Foundation Inc
Nedlands, Western Australia, 6009
Neurodegenerative Disorders Research Pty Ltd
Subiaco, Western Australia, 6008
Russia7 sites
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
Moscow, 109388
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
Moscow, 115522
Mental Health Research Center of the Russian Academy of Medical Sciences
Moscow, 115522
City Clinical Hospital #34, City Scientific Practical Neurological Center
Novosibirsk, 630054
City Geriatric Medical and Social Center
Saint Petersburg, 190103
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
Saint Petersburg, 192019
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
Yekaterinburg, 620030
South Korea5 sites
Dong-A University Hospital
Busan, 602-715
Gachon University Gil Medical Center
Incheon, 405-760
Samsung Medical Center
Seoul, 135-710
Seoul National University Boramae Medical Center
Seoul, 156-707
Seoul National University Hospital
Seoul
Taiwan5 sites
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan
Spain4 sites
Fundació ACE
Barcelona, 08028
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Viamed Montecanal
Zaragoza, 50006
Belgium3 sites
University Hospital Ghent Department of Neurology
Ghent, 9000
Jessa Hospital
Hasselt, 3500
GZA Sint-Augustinus
Wilrijk, 2610
France3 sites
Hôpitaux Civils de Colmar
Colmar, Cedex, 68024
Centre de Recherche Clinique
Toulouse, 31059
Hôpital de Charpennes
Villeurbanne, 69100
Malaysia3 sites
University Kuala Lumpur Royal College of Medicine
Ipoh, 30450
Hospital Sultan Ismail
Johor Bahru, 81100
University Malaya Medical Centre
Kuala Lumpur, 50603
Croatia2 sites
University Hospital Centre Zagreb, Department of Neurology
Zagreb, 10000
University Psychiatric Hospital Vrapče
Zagreb, 10090
Finland2 sites
University of Eastern Finland, Brain Research Unit Mediteknia
Kuopio, 70210
Clinical Research Services Turku (CRST)
Turku, 20520
Germany2 sites
Charité, University Medicine Berlin, CBF, Neurology
Berlin, 12200
Arzeneimittelforschung Leipzig GmbH
Leipzig, 04107
Singapore2 sites
National University Hospital (NUH)
Singapore, 119228
National Neuroscience Institute (NNI)
Singapore, 308433
Romania1 site
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
Sibiu, 550082
About this study
Official title: 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.
- Being tested
- LMTM
- Keywords
- Dementia, Alzheimer Disease, bvFTD, Frontotemporal Dementia, Neurodegenerative Diseases, Brain Diseases, Cognitive Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Frontotemporal Dementia, Neurodegenerative Diseases, Brain Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMTMDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| LMTM | Experimental | Not described Receives: Drug: LMTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: This study has been terminated for administrative reasons only.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 913 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauRx Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245568
- Sponsor's protocol ID
- TRx-237-020
- Status last verified
- May 2023
- First submitted
- 27 Aug 2014
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
- ClinicalTrials.gov ID
- NCT02245568
- Acronym / sponsor ID
- TRx-237-020
- Keywords
- Dementia, Alzheimer Disease, bvFTD, Frontotemporal Dementia, Neurodegenerative Diseases, Brain Diseases, Cognitive Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated for administrative reasons only.
- Enrolment
- 913 participants (actual)
- Lead sponsor
- TauRx Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LMTM | Experimental | Drug: LMTM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMTMThe 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). | Drug | LMTM |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
135 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LMTM in people with Alzheimer's Disease and Behavioral Variant Frontotemporal Dementia, run by TauRx Therapeutics Ltd at 135 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 135 sites in United States, United Kingdom, Canada, Australia, Russia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious or Non-serious Adverse Events (time frame: Up to 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.