<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689233</url>
  </required_header>
  <id_info>
    <org_study_id>TRx-237-005</org_study_id>
    <nct_id>NCT01689233</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease</brief_title>
  <official_title>Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TauRx Therapeutics Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TauRx Therapeutics Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment&#xD;
      of subjects with mild Alzheimer's Disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)</measure>
    <time_frame>78 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)</measure>
    <time_frame>78 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes</measure>
    <time_frame>78 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)</measure>
    <time_frame>78 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Mini-Mental Status Examination (MMSE)</measure>
    <time_frame>78 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Neuropsychiatric Inventory (NPI)</measure>
    <time_frame>78 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>78 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in expected decline of whole brain volume as measured by brain MRI</measure>
    <time_frame>78 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite</measure>
    <time_frame>78 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture</measure>
    <time_frame>78 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>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</measure>
    <time_frame>78 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging</measure>
    <time_frame>78 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in expected increase in ventricular volume as measured by brain MRI</measure>
    <time_frame>78 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in expected decline in hippocampal volume as measured by brain MRI</measure>
    <time_frame>78 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>TRx0237 200 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TRx0237 200 mg/day</intervention_name>
    <description>TRx0237 100 mg tablets will be administered twice daily.</description>
    <arm_group_label>TRx0237 200 mg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of all cause dementia and probable Alzheimer's disease&#xD;
&#xD;
          -  Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild) and MMSE score of 20-26&#xD;
             (inclusive)&#xD;
&#xD;
          -  Age &lt;90 years&#xD;
&#xD;
          -  Modified Hachinski ischemic score of ≤4&#xD;
&#xD;
          -  Females, if of child-bearing potential, must practice true abstinence or be competent&#xD;
             to use adequate contraception and agree to maintain this throughout the study&#xD;
&#xD;
          -  Subject, and/or, in the case of reduced decision-making capacity, legally acceptable&#xD;
             representative(s) consistent with national law is/are able to read, understand, and&#xD;
             provide written informed consent&#xD;
&#xD;
          -  Has one (or more) identified adult caregiver who is willing to provide written&#xD;
             informed consent for his/her own participation; is able to read, understand, and speak&#xD;
             the designated language at the study site; either lives with the subject or sees the&#xD;
             subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study&#xD;
             visit; and is able to verify daily compliance with study drug&#xD;
&#xD;
          -  If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of&#xD;
             Screening, the subject must have been taking such medication(s) for ≥3 months. The&#xD;
             dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain&#xD;
             stable throughout participation in the study.&#xD;
&#xD;
          -  Able to comply with the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant central nervous system (CNS) disorder other than Alzheimer's disease&#xD;
&#xD;
          -  Significant focal or vascular intracranial pathology seen on brain MRI scan&#xD;
&#xD;
          -  Clinical evidence or history of stroke, transient ischemic attack, significant head&#xD;
             injury or other unexplained or recurrent loss of consciousness ≥15 minutes&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar&#xD;
             disorder, substance (including alcohol) related disorders&#xD;
&#xD;
          -  Metal implants in the head (except dental), pacemaker, cochlear implants, or any other&#xD;
             non-removable items that are contraindications to MRI&#xD;
&#xD;
          -  Resides in hospital or moderate to high dependency continuous care facility&#xD;
&#xD;
          -  History of swallowing difficulties&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Glucose-6-phosphate dehydrogenase deficiency&#xD;
&#xD;
          -  History of significant hematological abnormality or current acute or chronic&#xD;
             clinically significant abnormality&#xD;
&#xD;
          -  Abnormal serum chemistry laboratory value at Screening deemed to be clinically&#xD;
             relevant by the investigator&#xD;
&#xD;
          -  Clinically significant cardiovascular disease or abnormal assessments&#xD;
&#xD;
          -  Preexisting or current signs or symptoms of respiratory failure&#xD;
&#xD;
          -  Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine&#xD;
             disease (not adequately treated) and/or other unstable or major disease other than&#xD;
             Alzheimer's disease&#xD;
&#xD;
          -  Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell&#xD;
             or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted&#xD;
             in complete freedom from disease for at least 2 years&#xD;
&#xD;
          -  Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar&#xD;
             organic dyes, or any of the excipients&#xD;
&#xD;
          -  Treatment currently or within 3 months before Baseline with any of the following&#xD;
             medications (unless otherwise noted):&#xD;
&#xD;
               -  Tacrine&#xD;
&#xD;
               -  Clozapine, olanzapine (and there is no intent to initiate therapy during the&#xD;
                  course of the study)&#xD;
&#xD;
               -  Carbamazepine, primidone&#xD;
&#xD;
               -  Drugs with a warning or precaution in the labeling of methemoglobinemia at&#xD;
                  approved doses&#xD;
&#xD;
          -  Current or prior participation in a clinical trial as follows:&#xD;
&#xD;
               -  Clinical trial of a product for cognition in which the last dose was received&#xD;
                  within 90 days prior to Screening (unless confirmed to have been randomized to&#xD;
                  placebo)&#xD;
&#xD;
               -  A clinical trial of a drug, biologic, device, or medical food in which the last&#xD;
                  dose/administration was received within 28 days prior to Baseline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xenoscience, Inc / 21st Century Neurology</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NoesisPharma Clinical Trials</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITrials</name>
      <address>
        <city>Bellflower</city>
        <state>California</state>
        <zip>90706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ATP Clinical Research, Inc.</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research, LLC</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Feldman, Robert MD</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy East</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Therapeutics, Inc.</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anderson Clinical Research</name>
      <address>
        <city>Redlands</city>
        <state>California</state>
        <zip>92374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Clinical Research Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Research Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schuster Medical Research Institute</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mile High Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Neurodegenerative Disorders</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Connecticut Research, LLC</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center for Clinical Studies, Inc</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06851</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JEM Research</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradenton Research Center</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research and Treatment Center</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Roskamp Institute, Inc.</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axiom Clinical Research of Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF Health Byrd Alzheimer's Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC - North Clinic</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute (Palm Beach Neurology)</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurostudies.net</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Neurosciences Institute</name>
      <address>
        <city>Elk Grove</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruan Neurology Clinic and Research Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CBH Health, LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quest Research Institute</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Research Center - Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olive Branch Family Medical</name>
      <address>
        <city>Olive Branch</city>
        <state>Mississippi</state>
        <zip>38654</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Psychiatric Associates</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Enhancement Centers of America, Inc</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Memory Research Institute of NJ PC</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Neuroscience</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Associates of Albany, P. C.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedicalPsych Care, PLLC</name>
      <address>
        <city>Elmsford</city>
        <state>New York</state>
        <zip>10523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Taub Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Foundation for Mental Hygiene, Inc.</name>
      <address>
        <city>Orangeburg</city>
        <state>New York</state>
        <zip>10962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America, Inc</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurobehavorial Clinical Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
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        <state>Oklahoma</state>
        <zip>73112</zip>
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        <zip>19046</zip>
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      <name>RI Hospital</name>
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        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
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      <name>Neurology Clinic, P.C.</name>
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        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
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      <name>Clinical Neuroscience Solutions CNS Healthcare</name>
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        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
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  </location>
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    <facility>
      <name>Senior Adults Specialty Research, Inc.</name>
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        <city>Austin</city>
        <state>Texas</state>
        <zip>78757</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Dallas, LP</name>
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        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
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  </location>
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    <facility>
      <name>PRA Health Sciences</name>
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        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Psychiatric Consultants</name>
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        <city>Waukesha</city>
        <state>Wisconsin</state>
        <zip>53188</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Discipline of Psychiatry, University of Queensland</name>
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        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Brussels Department of Neurology</name>
      <address>
        <city>Bruxelles</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Gent Department of Neurology</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Hospital</name>
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        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital Sint-Trudo</name>
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        <city>Sint-Truiden</city>
        <zip>3800</zip>
        <country>Belgium</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GasthuisZusters Antwerpen Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkwood Institute</name>
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        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 0A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Memory Program</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Zagreb, Department of Neurology</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Psychiatric Hospital Vrapče</name>
      <address>
        <city>Zagreb</city>
        <zip>10090</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Eastern Finland, Brain Research Unit Mediteknia</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Services Turku (CRST)</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Civils de Colmar</name>
      <address>
        <city>Colmar Cedex</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Grave</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Charpennes</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurozentrum Achim Dr. med. Andreas Mahler</name>
      <address>
        <city>Achim</city>
        <zip>28832</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>University Medicine Berlin - Charité, CBF, Neurology</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Clinic, ECRC</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arzeneimittelforschung Leipzig GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04107</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS San Giovanni di Dio - Fatebenefratelli</name>
      <address>
        <city>Brescia</city>
        <zip>25125</zip>
        <country>Italy</country>
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  </location>
  <location>
    <facility>
      <name>Fondazione Universita 'G. D'Annunzio di Chieti</name>
      <address>
        <city>Chieti Scalo</city>
        <zip>66100</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neurology Department of Neuroscience (DINOGMI) - University of Genoa</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia</name>
      <address>
        <city>Roma</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer Center Southwest Netherlands, Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacio ACE</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Mútua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grampian NHS, Royal Cornhill Hospital</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit</name>
      <address>
        <city>Crowborough</city>
        <zip>TN6 1HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Re:Cogniton Health</name>
      <address>
        <city>London</city>
        <zip>W1G 9JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Assessment and Research Centre (MARC)</name>
      <address>
        <city>Southampton</city>
        <zip>SO30 3JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingshill Research Centre, Victoria Hospital</name>
      <address>
        <city>Swindon</city>
        <zip>SN3 6BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Poland</country>
  </removed_countries>
  <link>
    <url>http://www.AlzheimersStudies.com</url>
    <description>Alzheimer's Survey</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <disposition_first_submitted>March 12, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 12, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 14, 2018</disposition_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Alzheimer Disease</keyword>
  <keyword>TRx0237</keyword>
  <keyword>AD</keyword>
  <keyword>Neurodegenerative Diseases</keyword>
  <keyword>Dementia</keyword>
  <keyword>Brain Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689233
org study id: TRx-237-005
nct id: NCT01689233
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment
      of subjects with mild Alzheimer's Disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
time frame: 78 weeks
measure: Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
time frame: 78 weeks
measure: Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
time frame: 78 weeks
description: 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.
measure: Change from Baseline in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
time frame: 78 weeks
measure: Change from Baseline in Mini-Mental Status Examination (MMSE)
time frame: 78 weeks
measure: Change from Baseline in Neuropsychiatric Inventory (NPI)
time frame: 78 weeks
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
time frame: 78 weeks
measure: Change in expected decline of whole brain volume as measured by brain MRI
time frame: 78 weeks
measure: Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite
time frame: 78 weeks
measure: Change in cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture
time frame: 78 weeks
measure: 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
measure: Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging
time frame: 78 weeks
measure: Change in expected increase in ventricular volume as measured by brain MRI
time frame: 78 weeks
measure: Change in expected decline in hippocampal volume as measured by brain MRI
time frame: 78 weeks
arm group label: TRx0237 200 mg/day
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: TRx0237 200 mg/day
description: TRx0237 100 mg tablets will be administered twice daily.
arm group label: TRx0237 200 mg/day
intervention type: Drug
intervention name: Placebo
description: 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.
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: 89 Years
healthy volunteers: No
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country: Australia
country: Belgium
country: Canada
country: Croatia
country: Finland
country: France
country: Germany
country: Italy
country: Netherlands
country: Spain
country: United Kingdom
country: United States
country: Poland
url: http://www.AlzheimersStudies.com
description: Alzheimer's Survey
responsible party type: Sponsor
mesh term: Alzheimer Disease