Trial record 3 of 9 for:    TauRx

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by TauRx Therapeutics Ltd
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01689233
First received: September 14, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: TRx0237 200 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, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by TauRx Therapeutics Ltd:

Primary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes [ Time Frame: 78 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 serotonin toxicity, brain magnetic resonance imaging (MRI), and potential for suicide or self-harm.


Secondary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mini-Mental Status Examination (MMSE) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in expected decline of whole brain volume as measured by brain MRI [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change in cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture [ Time Frame: 78 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: 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRx0237 200 mg/day Drug: TRx0237 200 mg/day
TRx0237 100 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.

  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 0.5 or 1 (mild) and MMSE score of 20-26 (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, 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 (unless otherwise noted):

    • Tacrine
    • Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
    • Carbamazepine, primidone
    • Drugs known to pose more than a very rare risk (1/10,000 cases) of methemoglobinemia at approved doses
  • Current or prior participation in a clinical trial as follows:

    • Clinical trial of a product for cognition in which the last dose was received within 90 days prior to Screening (unless confirmed to have been randomized to placebo)
    • A clinical trial of a drug, biologic, 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: NCT01689233

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

  Hide Study Locations
Locations
United States, Arizona
NoesisPharma Clinical Trials Recruiting
Phoenix, Arizona, United States, 85032
Contact: Lee Ann Kelley, MD    602-795-1834    lak@kelleymd.com   
Xenoscience, Inc / 21st Century Neurology Recruiting
Phoenix, Arizona, United States, 85004
Contact: Stephen Flitman, MD    602-274-9500    sflitman@xenoscience.com   
United States, California
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
Contact: Gustavo Alva, MD    714-277-4472    galva@theatpgroup.net   
Diligent Clinical Trials, Inc. Recruiting
Downey, California, United States, 90241
Contact: Elizabeth Zarate-Rowell, MD    562-622-0700    elizabethrowellmd@diligentclinicaltrials.com   
Synergy Escondido Recruiting
Escondido, California, United States, 92025
Contact: Charmaine Semeniuk, MD    760-871-0286    semeniukc@synergyescondido.com   
Southern California Research, LLC Recruiting
Fountain Valley, California, United States, 92708
Contact: John Murphy, MD    714-665-1277    jjmurphy@SCRstudies.com   
Feldman, Robert MD Recruiting
Laguna Hills, California, United States, 92653
Contact: Robert Feldman, MD    949-588-0909    rgfeldman@cox.net   
Collaborative Neuroscience Network Recruiting
Long Beach, California, United States, 90806
Contact: Omid Omidvar, MD    877-411-1616    omidomidvar@cnstrial.com   
Neuro-Therapeutics, Inc. Recruiting
Pasadena, California, United States, 91105
Contact: Richard Shubin, MD    626-356-0800    neuro47@sbcglobal.net   
Anderson Clinical Research Recruiting
Redlands, California, United States, 92374
Contact: Don Anderson, MD    909-792-9007    dla@andersonstudies.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   
Neurological Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: David Kudrow, MD    310-315-1456    dbkudrow@earthlink.net   
Schuster Medical Research Institute Recruiting
Sherman Oaks, California, United States, 91403
Contact: Martin Schuster, MD    818-788-0746    schuster@smrionline.com   
United States, Colorado
Mile High Research Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jack Klapper, MD    303-877-2429    jkheaddoc@gmail.com   
United States, Connecticut
Institute for Neurodegenerative Disorders Recruiting
New Haven, Connecticut, United States, 06510
Contact: Dana Jennings, MD    203-401-4300    Djennings@indd.org   
Coastal Connecticut Research, LLC Recruiting
New London, Connecticut, United States, 06320
Contact: Laurence Radin, MD    860-437-7092    DrRadin.CCR@gmail.com   
Research Center for Clinical Studies, Inc Recruiting
Norwalk, Connecticut, United States, 06851
Contact: Bart Sloan, MD    203-838-0070    bsloan@rccsmail.com   
United States, Florida
JEM Research Recruiting
Atlantis, Florida, United States, 33462
Contact: Mark Goldstein, MD    561-968-2933    MGoldstein@jemri.net   
Bradenton Research Center Recruiting
Bradenton, Florida, United States, 34205
Contact: William McElveen, MD    941-708-0005    wam_md@bradentonresearch.com   
Meridien Research Recruiting
Brooksville, Florida, United States, 34601
Contact: Kelli Maw, MD    352-597-8839    kmaw@meridienresearch.net   
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Mark Brody, MD    561-764-8461    mbrody@brainmattersresearch.com   
Clinical Physiology Associates Recruiting
Fort Myers, Florida, United States, 33916
Contact: Ronica Kluge, MD    239-936-4421    rkluge@clinphys.com   
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: Beth Safirstein, MD    954-455-5757    bsafirstein@mdclinical.org   
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Contact: Michael Neam, MD    561-209-2400    mneam@researchalz.com   
Compass Research, LLC - North Clinic Recruiting
Leesburg, Florida, United States, 34748
Contact: James McDonough, MD    352-261-0901    drmcdonough@compassresearch.org   
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Contact: Marc Agronin, MD    305-751-8626    MAgronin@mjhha.org   
Compass Research, LLC Recruiting
Orlando, Florida, United States, 32806
Contact: Craig Curtis, MD    407-426-9299    Drcurtis@compassresearch.com   
Neurostudies, Inc. Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Liliana Montoya, MD    941-743-1027    Neurostudies4@daystar.net   
The Roskamp Institute, Inc. Recruiting
Sarasota, Florida, United States, 34243
Contact: Andrew Keegan, MD    941-256-8018    akeegan@rfdn.org   
Neurology Clinical Research, Inc. Recruiting
Sunrise, Florida, United States, 33351
Contact: Richard Singer, MD    954-475-8171 ext 143    rsinger@neuroresearch.net   
Axiom Clinical Research of Florida Recruiting
Tampa, Florida, United States, 33609
Contact: Susan Steen, MD    813-353-9613    Ssteen.axiom@gmail.com   
USF Health Byrd Alzheimer's Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Balebail Raj, MD    813-874-1294    Braj@health.usf.edu   
Premiere Research Institute (Palm Beach Neurology) Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Carl Sadowsky, MD    561-845-0500 ext 124    chsadow@aol.com   
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30308
Contact: Robert Riesenberg, MD    404-881-5800    rriesenberg@acmr.org   
Neurostudies.net Recruiting
Decatur, Georgia, United States, 30033
Contact: Marshall Nash, MD    404-475-0552    mnash@neurostudies.net   
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, Iowa
Ruan Neurology Clinic and Research Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Michael Jacoby, MD    515-358-0023    iowaclinicalresearch@mercydesmoines.org   
United States, Maryland
CBH Health, LLC Recruiting
Rockville, Maryland, United States, 20850
Contact: Robert Litman, MD    301-251-4702    relitman@cbhhealth.com   
United States, Massachusetts
ActivMed Practices & Research Recruiting
Methuen, Massachusetts, United States, 01844
Contact: Michael McCartney, MD    978-655-7155    mmccartney@activmedresearch.com   
Neurocare Center for Research Recruiting
Newton, Massachusetts, United States, 02459
Contact: Michael Biber, MD    617-581-6434    mbiber@bidmc.harvard.edu   
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Aaron Ellenbogen, MD    248-957-8940    aaron@questri.com   
United States, Mississippi
Neurological Research Center - Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Ronald Schwartz, MD    601-573-5345    ronald.schwartz@hattiesburgclinic.com   
Olive Branch Family Medical Recruiting
Olive Branch, Mississippi, United States, 38654
Contact: Randall Huling, MD    662-893-8474    rhuling@obfmc.com   
United States, Missouri
Millennium Psychiatric Associates Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Franco Sicuro, MD    314-298-0001    fsicuro@millenniumpa.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   
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 Mexico
Albuquerque Neuroscience Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Glen Michael Dempsey, MD    505-848-3773    gmdempsey@albneuro.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   
MedicalPsych Care, PLLC Recruiting
Elmsford, New York, United States, 10523
Contact: James Chou, MD    914-345-9154    JimChou66@medicalpsychcare.com   
Empire Neurology, PC Recruiting
Latham, New York, United States, 12110
Contact: Keith Edwards, MD    518-785-1000    kedwards@tristateneuro.com   
Columbia University Taub Institute Recruiting
New York, New York, United States, 10032
Contact: Lawrence Honig, MD    212-305-2371    lh456@cumc.columbia.edu   
Research Foundation for Mental Hygiene, Inc. Recruiting
Orangeburg, New York, United States, 10962
Contact: Nunzio Pomara, MD    845-398-5579    pomara@nki.rfmh.org   
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact: Mark DiBuono, MD    718-317-5522 ext 2    dibuono@rbany.com   
United States, North Carolina
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Singar Jadadeesan, MD    919-781-2514    sjagadeesan@wakeresearch.com   
Clinical Trials of America, Inc Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Beverly Jones, MD    336-768-3456    bjones@ctamerica.net   
United States, Ohio
Neurobehavorial Clinical Research Recruiting
Canton, Ohio, United States, 44718
Contact: Shishuka Malhotra, MD    330-493-1118    smalhotra@nb-cr.com   
United States, Oklahoma
Oklahoma Clinical Research Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Lane Peyton, MD    405-753-4994    drpeyton@okcrc.net   
Red River Medical Research Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Amal Chakrburtty, MD    405-759-5600    drchakraburtty@redriverokc.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, Rhode Island
Rhode Island Mood and Memory Research Institute Recruiting
East Providence, Rhode Island, United States, 02914
Contact: John Stoukides, MD    401-435-8950    jstoukides@rimmri.com   
RI Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Brian Ott, MD    401-444-6440    bott@lifespan.org   
United States, Tennessee
Neurology Clinic, P.C. Recruiting
Cordova, Tennessee, United States, 38018
Contact: Lee Stein, MD    901-866-9252    research@neuroclinic.org   
Clinical Neuroscience Solutions CNS Healthcare Recruiting
Memphis, Tennessee, United States, 38119
Contact: Lora McGill, MD    901-843-1045    Lmcgill@cnshealthcare.com   
United States, Texas
Senior Adults Specialty Research, Inc. Recruiting
Austin, Texas, United States, 78757
Contact: Jaron Winston, MD    512-407-8628    jw@senioradults.net   
FutureSearch Trials of Dallas, LP Recruiting
Dallas, Texas, United States, 75231
Contact: Michael Downing, MD    214-369-2600    michaeld@fstrials.com   
United States, Utah
CRI Lifetree Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Miroslav Backonja, MD    801-269-8200    mbackonja@crilifetree.com   
United States, Vermont
The Memory Clinic Recruiting
Bennington, Vermont, United States, 05201
Contact: Lisa Catapano-Friedman, MD    802-447-1409    Psingpsych1@gmail.com   
United States, Wisconsin
Independent Psychiatric Consultants Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Cary Kohlenberg, MD    262-513-0700    caryjkohlenberg@gmail.com   
Australia, New South Wales
Academic Department for Old Age Psychiatry, Prince of Wales Hospital Not yet 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 Queensland Not yet recruiting
Herston, Queensland, Australia, 4006
Contact: Gerard Byrne, MD    61 7 3365 5147    gerard.byrne@uq.edu.au   
Australia, Victoria
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital Not yet recruiting
Heidelberg West, Victoria, Australia, 3081
Contact: Michael Woodward, MD    61 3 9496 2181    michael.woodward@austin.org.au   
Belgium
Universitair Ziekenhius Brussel Dienst neurologie Recruiting
Bruxelles, Belgium, 1090
Contact: Jan Versijpt, MD, PhD    0032 247 637 39    jan.versijpt@uzbrussel.be   
University Hospital Gent Department of Neurology Recruiting
Gent, Belgium, 9000
Contact: Anne Sieben, MD    0032 9332 6483    anne.sieben@ugent.be   
Jessa Ziekenhuis Hospital Recruiting
Hasselt, Belgium, 3500
Contact: Nina De Klippel    0032 11 309785    nina.deklippel@jessazh.be   
Regional Hospital St. Truiden Recruiting
Sint-Truiden, Belgium, 3800
Contact: Eddy Mulleners, MD    0032 11 699560    eddy.mulleners@rzst.be   
GasthuisZusters Antwerpen Sint-Augustinus Recruiting
Wilrijk, Belgium, 2610
Contact: William van Landegem, MD    0032 495 53 59 58    william.vanlandegem@telenet.be   
Canada, Alberta
Heritage Medical Research Clinic Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: David Patry, MD    403-220-8394    dgpatry@ucalgary.ca   
Canada, British Columbia
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Robin Hsiung, MD    604-822-1782    hsiung@mail.ubc.ca   
Canada, Ontario
Parkwood Hospital, St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Stephen Pasternak, MD    519-685-4292 ext 42626    spasternak@robarts.ca   
Toronto Memory Program Recruiting
Toronto, Ontario, Canada, M3B 2S7
Contact: Sharon Cohen, MD    416-386-9761    cohen@memorydisorders.ca   
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Howard Cherktow, MD    514-340-8222 ext 7501    howard.chertkow@mcgill.ca   
Croatia
Psychiatric Clinic Vrapče Recruiting
Zagreb, Croatia, 10090
Contact: Ninoslav Mimica, MD    385 1 3780 678    ninoslav.mimica@bolnica-vrapce.hr   
University Hospital Centre Zagreb, Department of Neurology Recruiting
Zagreb, Croatia, 10000
Contact: Natasa Klepac, MD    38598541889    natasa.klepac@zg.t-com.hr   
Finland
University of Eastern Finland, Brain Research Unit Mediteknia Recruiting
Kuopio, Finland, 70210
Contact: Merja Hallikainen, MD    00358 17 173 501    merja.hallikainen@uef.fi   
Clinical Research Services Turku (CRST) Recruiting
Turku, Finland, 20520
Contact: Juha Rinne, MD    00358 2 313 1866    juha.rinne@tyks.fi   
France
Hôpitaux Civils de Colmar Recruiting
Colmar Cedex, France, 68024
Contact: Francois Sellal, MD    0033 389 124150    francois.sellal@ch-colmar.fr   
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille, France, 13385
Contact: Matthieu Ceccaldi, Prof.    0033 4 91 38 59 28    Mathieu-pierre.CECCALDI@ap-hm.fr   
Hôpital Casselardit Recruiting
Toulouse, France, 31300
Contact: Pierre Jean Ousset, MD    0033 56177 6455    ousset.pj@chu-toulouse.fr   
Hôpital de Charpennes Recruiting
Villeurbanne, France, 69100
Contact: Pierre Krolak-Salmon, MD    0033 472 432050    pierre.krolak-salmon@chu-lyon.fr   
Germany
Neurozentrum Achim Dr. med. Andreas Mahler Recruiting
Achim, Germany, 28832
Contact: Andreas Mahler, MD    0049 4202 764 900    research@neuro-achim.de   
University Medicine Berlin - Charité, CBF, Neurology Recruiting
Berlin, Germany, 12200
Contact: Andreas Lüschow, MD    0049 030 451 550606    andreas.lueschow@charite.de   
Klinik für Psychiatrie und Psychotherapie - Charité Recruiting
Berlin, Germany, 14050
Contact: Oliver Peters, MD    0049 0 3084458215    oliver.peters@charite.de   
Arzeneimittelforschung Leipzig GmbH Recruiting
Leipzig, Germany, 04107
Contact: Erik Strauß, MD    0049 0341 910 4884    erik.strauss@kopfzentrum-leipzig.de   
Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock Recruiting
Rostock, Germany, 18147
Contact: Johannes Thome, Prof. Dr.    0049 0381 4949505    Johannes.thome@med.uni-rostock.de   
Italy
Universita degli Studi Politecnica della Marche Recruiting
Ancona, Italy, 60126
Contact: Leandro Provinciali, MD    0039 071 887 262    l.provinciali@univpm.it   
IRCCS San Giovanni di Dio - FBF Recruiting
Brescia, Italy, 25125
Contact: Giovanni Frisoni, MD    0030 3501261    giovanni.frisoni@gmail.com   
Clinica Neurologica Dipartimento di Neuroscienze e Imaging Università "G.D'Annunzio" Chieti-Pescara Recruiting
Chieti Scalo, Italy, 66100
Contact: Marco Onofrj, MD    0039 0871 562019    onofrj@unich.it   
Azienda ospedaliera San Martino di Genova - Neurofisiologia Clinica Recruiting
Genova, Italy, 16132
Contact: Flavio Nobili, MD    0039 010 3537568    flaviomariano.nobili@hsanmartino.it   
Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia Not yet recruiting
Roma, Italy, 00189
Contact: Franco Giubilei, MD    39 0633775435    franco.giubilei@uniroma1.it   
Netherlands
Alzheimer Research Center Recruiting
Amsterdam, Netherlands, 1081
Contact: Niels Prins, MD    31 622 378036    nd.prins@vumc.nl   
Alzheimer Center Southwest Netherlands, Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Contact: John Van Swieten, Prof.    31 10 703 32 74    j.c.vanswieten@erasmusmc.nl   
Poland
Pallmed sp zoo prowadzaca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszlego Not yet recruiting
Bydgoszcz, Poland, 85-796
Contact: Robert Kucharski, Dr    48 52 348 56 42    r.kucharski@domsueryder.org.pl   
NZOZ Wielospecjalistyczna Poradnia Lekarska "SYNAPSIS" Not yet recruiting
Katowice, Poland, 40-123
Contact: Lech Szczechowski, Dr.    48 322 010838    lszczechowski@gmail.com   
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska Not yet recruiting
Mosina, Poland, 62-050
Contact: Danuta Pruchnik-Wollinska, MD    48 618 132440    pruchnik@pro.onet.pl   
Euromedis Sp. z o.o. Not yet recruiting
Szczecin, Poland, 70-125
Contact: Andrzej Potemkowski, Prof.    48 91 813 63 22    andrzej.potemkowski@wp.pl   
MTZ Clinical Research Sp. z o.o. Not yet recruiting
Warszawa, Poland
Contact: Danuta Milewska, MD    48 22 572 5922    dmilewska@poczta.onet.pl   
Spain
Fundacio ACE Recruiting
Barcelona, Spain, 08029
Contact: Merce Boada Rovira, MD    0034 93 444 73 18    mboada@fundacioace.com   
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Francesc Pujadas, MD    0034 932 746 100 ext 6607    fpujadas@vhebron.net   
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Ana Frank Garcia, MD    0034 917 277 444    afrankg@gmail.com   
Hospital Universitari Mútua de Terrassa Recruiting
Terrassa, Spain, 08221
Contact: Pilar Quílez Ferrer, MD    0034 937365050 ext 2787    pquilez@mutuaterrassa.es   
United Kingdom
Grampian NHS, Royal Cornhill Hospital Recruiting
Aberdeen, United Kingdom, AB25 2ZH
Contact: Alasdair Lawrie, MD    44 (0) 1224 557031    alasdair.lawrie@nhst.net   
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit Recruiting
Crowborough, United Kingdom, TN6 1HB
Contact: Naji Tabet, MD    44 1892 603107    N.T.Tabet@brighton.ac.uk   
Re:Cogniton Health Recruiting
London, United Kingdom, W1G 9JF
Contact: Emer MacSweeney, MD    44 (0) 20 3355 3536    EMacsweeney@re-cognitionhealth.com   
Memory Assessment and Research Centre (MARC) Recruiting
Southampton, United Kingdom, SO30 3JB
Contact: Clive Holmes, MD    0044 0 2380 475216    c.holmes@soton.ac.uk   
Kingshill Research Centre, Victoria Hospital Recruiting
Swindon, United Kingdom, SN3 6BW
Contact: Roger Bullock, MD    0044 0 1793 327954    roger.bullock@awp.nhs.uk   
Sponsors and Collaborators
TauRx Therapeutics Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01689233     History of Changes
Other Study ID Numbers: TRx-237-005
Study First Received: September 14, 2012
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Croatia: Agency for Medicinal Product and Medical Devices
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014