Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by TauRx Therapeutics Ltd
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01689246
First received: September 14, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild to moderate Alzheimer's Disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: TRx0237 150 mg/day
Drug: TRx0237 250 mg/day
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by TauRx Therapeutics Ltd:

Primary Outcome Measures:
  • Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]
  • Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes [ Time Frame: 65 weeks ] [ Designated as safety issue: Yes ]
    Safety parameters include adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, potential for suicide and self-harm, brain magnetic resonance imaging (MRI), and potential for serotonin toxicity


Secondary Outcome Measures:
  • Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline on Mini-Mental Status Examination (MMSE) [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging [ Time Frame: 39 weeks and 65 weeks ] [ Designated as safety issue: No ]
  • Change in expected decline of whole brain volume as measured by brain MRI [ Time Frame: 39 weeks and 65 weeks ] [ Designated as safety issue: No ]
  • Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline on cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]
  • Compare the influence of Apolipoprotein E genotype on the primary and selected secondary outcomes in subjects by or for whom legally acceptable consent is separately provided [ Time Frame: 65 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 833
Study Start Date: February 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRx0237 250 mg/day Drug: TRx0237 250 mg/day
TRx0237 125 mg tablets will be administered twice daily.
Placebo Comparator: Placebo Drug: Placebo
Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
Experimental: TRx0237 150 mg/day Drug: TRx0237 150 mg/day
TRx0237 75 mg tablets will be administered twice daily.

  Eligibility

Ages Eligible for Study:   up to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of all cause dementia and probable Alzheimer's disease
  • Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score of 14-26 (inclusive)
  • Age < 90 years
  • Modified Hachinski ischemic score of ≤ 4
  • Females, if of child-bearing potential, must practice true abstinence or be competent 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 is/are able to read, understand, and provide written informed consent
  • Has one (or more) 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 ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
  • If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
  • Able to comply with the study procedures

Exclusion Criteria:

  • Significant central nervous system (CNS) disorder other than Alzheimer's disease
  • Significant focal or vascular intracranial pathology seen on brain MRI scan
  • Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
  • Epilepsy
  • Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders
  • Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
  • Resides in hospital or moderate to high dependency continuous care facility
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase deficiency
  • History of significant hematological abnormality or current acute or chronic clinically significant abnormality
  • Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
  • Clinically significant cardiovascular disease or abnormal assessments
  • Preexisting or current signs or symptoms of respiratory failure
  • Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
  • Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
  • Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
  • Treatment currently or within 3 months before Baseline with any of the following medications:

    • Tacrine
    • Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
    • Carbamazepine, primidone
    • Drugs associated with methemoglobinemia
  • Current or prior participation in a clinical trial as follows:

    • Clinical trial of a product for cognition within 3 months (unless confirmed to have been randomized to placebo)
    • A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689246

Contacts
Contact: Karen Pozzie 1-800-910-5609 info@alzheimersstudies.net

  Hide Study Locations
Locations
United States, Arizona
Xenoscience, Inc/ 21st Century Neurology Recruiting
Phoenix, Arizona, United States, 85004
Contact: Stephen Flitman, MD    602-274-9500    sflitman@xenoscience.com   
United States, California
Feldman, Robert MD Recruiting
Laguna Hills, California, United States, 92653
Contact: Robert Feldman, MD    949-588-0909    rgfeldman@cox.net   
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Lon Schneider, MD    323-442-7600    lschneid@usc.edu   
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92658
Contact: William Shankle, MD    949-478-8858    rshankle@mccare.com   
Pacific Research Network Recruiting
San Diego, California, United States, 92103
Contact: Stephen Thein, PhD    619-294-4302    sthein@prnsd.com   
San Francisco Clinical Research Center Recruiting
San Francisco, California, United States, 94118
Contact: Jerome Goldstein, MD    415-673-4600    SFHACLIN@aol.com   
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Christopher VanDyck, MD    203-764-8100    christopher.vandyck@yale.edu   
United States, Florida
JEM Research Recruiting
Atlantis, Florida, United States, 33462
Contact: Mark Goldstein, MD    561-968-2933    MGoldstein@jemri.net   
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Mark Brody, MD    561-374-8461    mbrody@brainmattersresearch.com   
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: Beth Safirstein, MD    954-455-5757    bsafirstein@mdclinical.org   
CNS Healthcare, Inc Recruiting
Jacksonville, Florida, United States, 32256
Contact: John Joyce, MD    904-281-5757    mjoyce@cnshealthcare.com   
Compass Research, LLC-North Clinic Recruiting
Leesburg, Florida, United States, 34748
Contact: James McDonough, MD    352-261-0901    drmcdonough@compassresearch.com   
Miami Research Associates Recruiting
Miami, Florida, United States, 33143
Contact: Bruce Kohrman, MD    305-279-0015    bkohrman@gmail.com   
Compass Research, LLC Recruiting
Orlando, Florida, United States, 32806
Contact: Kevin Radbill, DO    407-426-9299    drradbill@compassresearch.com   
United States, Georgia
iResearch Atlanta Recruiting
Decatur, Georgia, United States, 30030
Contact: Michael Burke, MD    404-537-1281    drburke@iresearchatlanta.com   
United States, Illinois
Alexian Brothers Neurosciences Institute Recruiting
Elk Grove, Illinois, United States, 60007
Contact: Concetta Forchetti, MD    847-593-8553    concetta.forchetti@alexian.net   
United States, Massachusetts
ActivMed Practices & Research Recruiting
Methuen, Massachusetts, United States, 01844
Contact: Michael McCartney, MD    603-319-8863    mmccartney@activmedresearch.com   
Neurocare Center for Research Recruiting
Newton, Massachusetts, United States, 02459
Contact: Michael Biber, MD    617-581-6434    mchlbiber1@gmail.com   
United States, Mississippi
Olive Branch Family Medical Recruiting
Olive Branch, Mississippi, United States, 38654
Contact: Randall Huling, MD    662-893-8474    rhuling@obfmc.com   
United States, New Jersey
Memory Enhancement Centers of America, Inc Recruiting
Eatontown, New Jersey, United States, 07724
Contact: Joel Ross, MD    732-263-0101    jrossmd@memorycenternj.com   
CRI Worldwide Recruiting
Marlton, New Jersey, United States, 08053
Contact: Steven Glass, MD    856-334-6062    sglass@crilifetree.com   
The Atlantic Neuroscience Institute Recruiting
Springfield, New Jersey, United States, 07801
Contact: Michelle Papka, PhD    973-850-4622    mpapka@thecrcnj.com   
Advanced Memory Research Institute of NJ PC Recruiting
Toms River, New Jersey, United States, 08757
Contact: Sanjiv Sharma, MD    732-341-9500    ssharma@amrinj.com   
United States, New York
Neurological Associates of Albany, P. C. Recruiting
Albany, New York, United States, 12208
Contact: Richard Holub, MD    518-449-2662    rholub@naaresearch.com   
SPRI Recruiting
Brooklyn, New York, United States, 11235
Contact: Nick Vatakis, MD    718-616-2400    nvatakis@spristudy.com   
United States, Ohio
Neurobehavioral Clinical Research Recruiting
Canton, Ohio, United States, 44718
Contact: Shishuka Malhotra, MD    330-493-1118    smalhotra@nb-cr.com   
United States, Pennsylvania
The Clinical Trial Center, LLC Recruiting
Jenkintown, Pennsylvania, United States, 19046
Contact: Marvin Kalafer, MD    215-884-1700    drkalafer@theclinicaltrialcenter.com   
United States, Texas
FutureSearch Trials of Neurology Recruiting
Austin, Texas, United States, 78731
Contact: John Hudson, MD    512-380-9595    jdh@sleepdoc.net   
Australia, New South Wales
Division of Rehabilitation and Aged Care Recruiting
Hornsby, New South Wales, Australia, 2077
Contact: Sussan Kurrle, MD    61 2 9477 9283    SKurrle@nsccahs.health.nsw.gov.au   
Southern Neurology Pty Limited Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Raymond Schwartz, MD    61 1300 114 438    rschwartz@southern-neurology.com.au   
Academic Department for Old Age Psychiatry, Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Henry Brodaty, MD    61 8 9389 6433    h.brodaty@unsw.edu.au   
Australia, Queensland
Discipline of Psychiatry, University of Qld Recruiting
Herston, Queensland, Australia, 4006
Contact: Gerard Byrne, MD    61 7 3365 5147    gerard.byrne@uq.edu.au   
Australia, South Australia
Royal Adelaide Hospital Memory Trials Centre Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Jane Hecker, MD    61 8 222 2798    janehecker@bigpond.com   
Memory Unit, Neurology, The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Contact: Karen Boundy, MD    61 8 8222 7865    Karyn.boundy@health.sa.gov.au   
Australia, Victoria
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital Recruiting
Heidelberg West, Victoria, Australia, 3081
Contact: Michael Woodward, MD    61 3 9496 2181    michael.woodward@austin.org.au   
Australia, Western Australia
McCusker Alzheimer's Research Foundation Inc Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Roger Clarnette, MD    61 2 9382 3733    mccuskerctd@alzheimers.com.au   
Neurodegenerative Disorders Research Pty Ltd Recruiting
Perth, Western Australia, Australia, 6005
Contact: Peter K Panegyres, MD    61 8 6380 2255      
Bulgaria
UMHAT "Alexandrovska" Clinic of Psychiatry First Department of Psychiatry Recruiting
Sofia, Bulgaria, 1431
Contact: Georgi Onchev, MD, PhD    359 2 9230680    georgeonchev@hotmail.com   
UMHAT "Alexandrovska" Clinic of Neurology Diseases Department of Neurodegenerative and Immune and Infectious Diseases of Central Nervous System with Sector for Treatment of Neuroinfections Recruiting
Sofia, Bulgaria, 1431
Contact: Latchezar Traykov, MD, PhD    359 2 9230544    traykov_l@yahoo.fr   
Canada, British Columbia
Okanagan Clinical Trials Recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Contact: Paul Latimer, MD, PhD    1 250 862 8141    dr@oktrials.ca   
Canada, Nova Scotia
True North Clinical Research Kentville Inc Recruiting
Kentville, Nova Scotia, Canada, B4N 4K9
Contact: Mark Johnston, MD    1 902 679 0536    mark.johnston@truenorthcr.com   
Canada, Ontario
Toronto Memory Program Recruiting
North York, Ontario, Canada, M3B 2S7
Contact: Sharon Cohen, MD    1 416 386 9761    cohen@memorydisorders.ca   
Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montreal, Quebec, Canada, H4H 1R3
Contact: René Desautéls, MD    1 514 761 6131    rene.desautels@douglas.mcgill.ca   
Croatia
University Hospital Centre Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Natasa Klepac, MD    385 98541889    natasaklepac@gmail.com   
University Psychiatric Hospital Vrapce Recruiting
Zagreb, Croatia, 10090
Contact: Ninoslav Mimica, MD    385 1 3780 678    ninoslav.mimica@bolnica-vrapce.hr   
Germany
Neurozentrum Achim Dr. med. Andreas Mahler Recruiting
Achim, Germany, 28832
Contact: Andreas Mahler, MD    49-4202-764900    research@neuro-achim.de   
Department of Psychiatry, Charité Recruiting
Berlin, Germany, 14050
Contact: Oliver Peters, PhD    49-30-84458215    oliver.peters@charite.de   
Charité, University Medicine Berlin, CBF, Neurology Recruiting
Berlin, Germany, 12200
Contact: Andreas Lüschow, MD    49-30-451550606    andreas.lueschow@charite.de   
Italy
Istituto Neurologico Carlo Besta Recruiting
Milano, Italy, 20133
Contact: Fabrizio Tagliavini, PhD    39 223942260    neuropatologia@istituto-besta.it   
Neurologia Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Contact: Elio Scarpini, MD    39 02 55033842    elio.scarpini@unimi.it   
IRCCS Istituto neurologico Casimiro Mondino Recruiting
Pavia, Italy, 27100
Contact: Elena Sinforiani, MD    39 382380290    elena.sinforiani@mondino.it   
Clinica Neurologica, Università di Perugia-Ospedale S. Maria della Misericordia Recruiting
Perugia, Italy, 06156
Contact: Lucilla Parnetti, MD    39 075 578 35 45    lucilla.parnetti@unipg.it   
Universita' Cattolica del Sacro Cuore Recruiting
Roma, Italy, 00168
Contact: Roberto Bernabei, MD    39 06 30154859    roberto.bernabei@rm.unicatt.it   
Azienda Ospedaliera Universitaria Sant'Andrea di Roma- Unita' di Neurologia Recruiting
Roma, Italy, 00189
Contact: Franco Giubilei, MD    39 0633775435    franco.giubilei@uniroma1.it   
Dipartimento di Neuroscienze Universita' di Torino Recruiting
Torino, Italy, 10126
Contact: Innocenzo Rainero, MD    39 011 6334763    innocenzo.rainero@unito.it   
Azienda Ospedaliera S.maria Della Misericordia Recruiting
Udine, Italy, 33100
Contact: Pierluigi Dolso, MD    39 0432 989336    dolso.pierluigi@aoud.sanita.fvg.it   
U.O. Di Neurologia Ospedale di Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Contact: Marco Mauri, MD    39 0332278427    marco.mauri@uninsubria.it   
Korea, Republic of
Dong-A Medical Center Recruiting
Busan, Korea, Republic of
Contact: Kyung Won Park, MD    82 51-240-2966    neuropark@dau.ac.kr   
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Kee Hyung Park, MD    82 32-460-8683    khpark0813@gmail.com   
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Seong Hye Choi, MD    82 32-890-3659    seonghye@inha.ac.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of
Contact: Sang Yun Kim, MD    82 31-787-7462    neurosky@snu.ac.kr   
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Won Yang    82 10-3354-7368    neuroman@catholic.ac.kr   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Doh Kwan Kim, MD    82 2-3410-3582    paulkim@skku.edu   
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jun-Young Lee, MD    82 2-870-2462    benji@snu.ac.kr   
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Woo Lee, MD    82 10-2669-3577    dwlee@paik.ac.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Young Lee, MD    82 2-2072-2205    selfpsy@snu.ac.kr   
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Ho Ryu, MD    82 10-3786-7626    shryu@kuh.ac.kr   
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jae-Hong Lee, MD    82 2-3010-3446    jhlee@amc.seoul.kr   
Malaysia
University Kuala Lumpur Royal College of Medicine Recruiting
Ipoh, Malaysia, 30450
Contact: Esther Ebenzer, MD    60 5 2432635    esthergunamy@yahoo.com   
Hospital Sultan Ismail Recruiting
Johor Bahru, Malaysia, 81100
Contact: Suraya Yusoff, MD    60 7 3565121    krysu59@gmail.com   
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Chin Ai-Vyrn, PhD    60 1 66398293    a-vchin@hotmail.com   
Hospital Seberang Jaya Recruiting
Pulau Pinang, Malaysia, 13700
Contact: Irene Looi, MBBS    60 16 4815721    irenelooi@yahoo.com   
Taiping Hospital Recruiting
Taiping, Malaysia, 34000
Contact: Cheah Wee Kooi, MBBS    60 5 8083333    wkcheah@hotmail.com   
Poland
Podlaskie Centrum Psychogeriatrii Recruiting
Białystok, Poland, 15-732
Contact: Jacek Dobryniewski, MD, PhD    48 661 02 98    jacekdobryniewski@gmail.com   
Pallmed sp zoo prowadząca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszłego Recruiting
Bydgoszcz, Poland, 85-796
Contact: Robert Kucharski, MD    48 52 348 56 42    r.kucharski@domsueryder.org.pl   
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS Recruiting
Katowice, Poland, 40-123
Contact: Lech Szczechowski, MD, PhD    48 322010838    lszczechowski@gmail.com   
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska Recruiting
Mosina, Poland, 62-050
Contact: Danuta Pruchnik-Wolińska, MD, PhD    48 618132440    pruchnik@pro.onet.pl   
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy Recruiting
Poznań, Poland, 61-853
Contact: Jan Ilkowski, MD    48 61 870 73 43    jan.ilkowski@neurokard.pl   
Euromedis Sp. z o.o. Recruiting
Szczecin, Poland, 70-215
Contact: Andrzej Potemkowski, Prof,MD,PhD    48 91 813 63 22    andrzej.potemkowski@wp.pl   
Usługi Lekarskie Sp.c Palasik, Żabierek Recruiting
Warszawa, Poland, 00-669
Contact: Witold Palasik, MD, PhD    48 601205861    witpal@wp.pl   
MTZ Clinical Research Sp. z o.o. Recruiting
Warszawa, Poland, 02-106
Contact: Anna Pfeffer-Baczuk, MD, PhD    48 22 572 5959    anna.pfeffer@mtz-clinical.pl   
mMED Recruiting
Warszawa, Poland, 01-697
Contact: Maciej Czarnecki, MD, PhD    48 501 762 789    maciej.czarnecki@mmed.pl   
Romania
County Emergency Clinical Hospital Arad, Psychiatry Department Recruiting
Arad, Romania, 310022
Contact: Delia Marina Podea, MD    40 722583757    deliapodea@yahoo.com   
CMDTA "Neomed" Recruiting
Brasov, Romania, 500283
Contact: Adina Maria Radu Simian, MD    40 745096597    adira@doctor.com   
University Emergency Central Military Hospital "Dr.Carol Davila", Psychiatry Department Recruiting
Bucharest, Romania, 010816
Contact: Daniel Vasile, PhD    40 722609430    danielvpsy@yahoo.com   
Clinical Hospital of Psychiatry "Prof. Dr. Alexandru Obregia", Psychiatry Department XIII Recruiting
Bucharest, Romania, 041915
Contact: Elena Gherman, MD    40 727818190    dr.elena_gherman@yahoo.com   
Psychomedical Consult Recruiting
Bucharest, Romania, 024072
Contact: Catalina Tudose, PhD    40 744586103    catalina.tudose52@gmail.com   
Clinical Municipal Hospital "Dr. Gavril Curteanu", Psychiatry Department Recruiting
Oradea, Romania, 410154
Contact: Alin Ovidiu Petris, MD    40 740851482    alinpetris@yahoo.com   
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III Recruiting
Sibiu, Romania, 550082
Contact: Cosmina Muntean, MD    40 724032128    cosmina97@yahoo.com   
Psychiatry Hospital "Dr. Gheorghe Preda", Center of Mental Health Recruiting
Sibiu, Romania, 550082
Contact: Ana Ioana Secelean, MD    40 744789100    amrpr2sibiu@yahoo.com   
Emergency Clinical County Hospital Sibiu, Neurology Department Recruiting
Sibiu, Romania, 550166
Contact: Marcel Pereanu, MD    40 745 658550    marcelpereanu@yahoo.com   
Russian Federation
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital" Recruiting
Ekaterinburg, Russian Federation, 620030
Contact: Alena Sidenkova, PhD    7 9126770895    sidenkovs@mail.ru   
Mental Health Research Center of the Russian Academy of Medical Sciences Recruiting
Moscow, Russian Federation, 115522
Contact: Svetlana Gavrilova, PhD    7 4993249615    sigavrilova@yandex.ru   
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways" Recruiting
Moscow, Russian Federation, 109388
Contact: Svetlana Malichenko, PhD    7 4953543916    s.malichenko@mail.ru   
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department Recruiting
Moscow, Russian Federation, 115522
Contact: Yaroslav Kalyn, PhD    7 4996145275    ybkalyn@yandex.ru   
CityClinical Hospital #34, City Scientific Practical Neurological Center Recruiting
Novosibirsk, Russian Federation, 630054
Contact: Elena Vostrikova, PhD    7 383 355 47 74    eveta@sibmail.ru   
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev Recruiting
Saint Petersburg, Russian Federation, 192019
Contact: Vladimir Mikhailov, PhD    7 812 412 71 28    vladmikh@yandex.ru   
Saint Nicholas Psychiatric Hospital Recruiting
Saint Petersburg, Russian Federation, 190121
Contact: Vasily Nekrasov, MD    7 812 714 76 35    vasilin81@rambler.ru   
City Geriatric Medical and Social Center Recruiting
Saint Petersburg, Russian Federation, 190103
Contact: Sofia Sluchevskaya, PhD    7 812 251 64 42    taurx237@gmail.com   
Singapore
National neuroscience Institute (NNI) Recruiting
Singapore, Singapore, 308433
Contact: Nagaendran Kandiah, MD    65 63577635    nagaendran_kandiah@nni.com.sg   
National University Hospital (NUH) Recruiting
Singapore, Singapore, 119223
Contact: Christopher Chen, MD    (65) 8515 9419    cplhchen@yahoo.com.sg   
Tan Tock Seng Hospital (TTSH) Recruiting
Singapore, Singapore, 308433
Contact: Mark Chan, MD    65 92472403    peng_chew_chan@ttsh.com.sg   
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Pui Sim Ong, MMed    65 6850 3258    pui_sim_ong@cgh.com.sg   
Spain
Hospital Universitario de Ceuta Recruiting
Ceuta, Spain, 51003
Contact: Rafael Merino de Torres, MD    34 956 907 000    nvazquefuentes0@yahoo.es   
Hospital Reina Sofía Recruiting
Córdoba, Spain, 14011
Contact: Eduardo Agüera Morales, MD    34 957012547    doctoredu@gmail.com   
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Teresa Moreno Ramos, MD    34 913303511    neurol.hcsc@salud.madrid.org   
Hospital Viamed Montecanal Recruiting
Zaragoza, Spain, 50006
Contact: Antonio Oliveros Cid, MD    34 976 218 131    aoliverosc@gmail.com   
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Contact: Wen Fu Wang, MD    886 4 7238595 ext 1940    125678@cch.org.tw   
Chang Gung Memorial Hospital, Kaohsiung Recruiting
Kaohsiung, Taiwan
Contact: Chiung-Chih Chang, MD    886 7 732 7123    neur099@adm.cgmh.org.tw   
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Yu-Wan Yang, MD    886 4-2205-2121 ext 5039    yahneuroyoung@yahoo.com.tw   
En Chu Kong Hospital Recruiting
Taipei, Taiwan
Contact: Sun Yu, MD    886 2-2672-3456 ext 6653    sunyu.jj.lu@gmail.com   
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Ming-Jang Chiu, PhD    886 23123456 ext 65339    mjchiu@ntu.edu.tw   
National Yang-Ming University School of Medicine Recruiting
Taipei, Taiwan
Contact: Wang PN, MD    886 2-2871-2121 ext 3171    pnwang@vghtpe.gov.tw   
Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan, Taiwan
Contact: Chin-Chang Huang, MD    886 3 328 1200 ext 8413    cch0537@adm.cgmh.org.tw   
United Kingdom
NHS Grampian, Department of Old Age Psychiatry Royal Cornhill Hospital Recruiting
Aberdeen, United Kingdom, AB25 2ZH
Contact: Alasdair Lawrie, MD    44 (0) 1224 557479    alasdair.lawrie@nhs.net   
RICE - The Research Institute for the Care of Older People Recruiting
Bath, United Kingdom, BA1 3NG
Contact: Roy Jones, MD, PhD    44 1225 476420    r.w.jones@bath.ac.uk   
Belfast Health and Social Care Trust (BHSCT) Recruiting
Belfast, United Kingdom, BT12 6BA
Contact: Peter Passmore, Prof    44 7711613739    p.passmore@qub.ac.uk   
The Barberry Centre Recruiting
Birmingham, United Kingdom, B15 2SG
Contact: Peter Bentham, MD    44 121 301 2067    Peter.Bentham@bsmhft.nhs.uk   
MAC Clinical Research Ltd Recruiting
Blackpool, United Kingdom, FY2 0JH
Contact: Christopher McWilliam, PhD    44 1253 444451    chrismcwilliam@macplc.com   
MAC Clinical Research Ltd Recruiting
Bradford, United Kingdom, BD3 0DQ
Contact: Mark Dale, MD    44 1274 414330    markdale@macplc.com   
MAC Clinical Research Ltd Recruiting
Cannock, United Kingdom, WS11 0BN
Contact: Aliya Asher, MD    44 1543 504670    Aliyaasher@macplc.com   
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Richard Perry, MD    44 (0)2033111194    Richard.Perry@imperial.nhs.uk   
Dementia Research Centre Recruiting
London, United Kingdom, WC1N 3BG
Contact: Cath Mummery, MD    44 (0) 20344 84773    cath.mummery@uclh.nhs.uk   
Re: Cognition Health Ltd. Recruiting
London, United Kingdom, W1G 9JF
Contact: Emer MacSweeney, MD    44 (0) 203355 3536    EMacsweeney@re-cognitionhealth.com   
MAC Clinical Research Ltd Recruiting
Manchester, United Kingdom, M32 0UT
Contact: Aliya Asher, MD    44 0161 864 1670    Aliyaasher@macplc.com   
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Christopher Kipps, MD    44 (0) 2380 796781    christopher.kipps@uhs.nhs.uk   
Sponsors and Collaborators
TauRx Therapeutics Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01689246     History of Changes
Other Study ID Numbers: TRx-237-015
Study First Received: September 14, 2012
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Croatia: Agency for Medicinal Product and Medical Devices
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by TauRx Therapeutics Ltd:
Alzheimer's Disease
Alzheimer Disease
TRx0237
AD
Neurodegenerative Diseases
Dementia
Brain Diseases

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014