<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/NCT01723670</url>
  </required_header>
  <id_info>
    <org_study_id>CCD-1109-PR-0072</org_study_id>
    <nct_id>NCT01723670</nct_id>
  </id_info>
  <brief_title>Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment</brief_title>
  <acronym>CT05</acronym>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CERESPIR</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CERESPIR</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to&#xD;
      2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive&#xD;
      impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the effects on change from baseline on brain atrophy</measure>
    <time_frame>pre-dose, Months 6, 12, 18, 24 and Washout</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the presence of other biomarkers of neuronal degeneration</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the presence of other biomarkers of neuronal degeneration</measure>
    <time_frame>Month 24</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in cognitive performance</measure>
    <time_frame>pre-dose, Month 6, Month 12, Month18, Month 24</time_frame>
    <description>rate of cognitive decline</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in global clinical status</measure>
    <time_frame>pre-dose, Month 6, Month 12, Month 18, Month 24</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>CHF 5074 1x</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral tablet, multidose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHF 5074 2x</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral tablet, multidose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo, oral tablet, multidose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CHF 5074 1x</intervention_name>
    <description>oral tablet, 1x, once a day for 24 months</description>
    <arm_group_label>CHF 5074 1x</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CHF 5074 2x</intervention_name>
    <description>oral tablet, 2x, once a day for 24 months</description>
    <arm_group_label>CHF 5074 2x</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral tablet,once a day for 24 months</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.&#xD;
&#xD;
          -  Diagnosis of amnestic Mild Cognitive Impairment.&#xD;
&#xD;
          -  Mini-Mental State Examination score higher than 24 at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Alzheimer's disease.&#xD;
&#xD;
          -  Any medical condition that could explain the subject's cognitive deficits.&#xD;
&#xD;
          -  MRI scans having evidence of pre-specified brain abnormalities.&#xD;
&#xD;
          -  History of stroke.&#xD;
&#xD;
          -  Vitamin B12 or folate deficiency.&#xD;
&#xD;
          -  Skin cancers and any cancer that is being actively treated.&#xD;
&#xD;
          -  Diagnosis of schizophrenia or recurrent mood disorder.&#xD;
&#xD;
          -  Abnormal kidney function.&#xD;
&#xD;
          -  Concomitant use of any study prohibitive medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel S Ross, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memory Enhancement Center of America</affiliation>
  </overall_official>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>February 9, 2015</last_update_submitted>
  <last_update_submitted_qc>February 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Nerve Degeneration</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01723670
org study id: CCD-1109-PR-0072
nct id: NCT01723670
lead sponsor: 
has dmc: Yes
To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to
      2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive
      impairment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: To determine the effects on change from baseline on brain atrophy
time frame: pre-dose, Months 6, 12, 18, 24 and Washout
measure: To determine the presence of other biomarkers of neuronal degeneration
time frame: Day 1
measure: To determine the presence of other biomarkers of neuronal degeneration
time frame: Month 24
measure: Change from baseline in cognitive performance
time frame: pre-dose, Month 6, Month 12, Month18, Month 24
description: rate of cognitive decline
measure: Change from baseline in global clinical status
time frame: pre-dose, Month 6, Month 12, Month 18, Month 24
arm group label: CHF 5074 1x
arm group type: Experimental
description: oral tablet, multidose
arm group label: CHF 5074 2x
arm group type: Experimental
description: oral tablet, multidose
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo, oral tablet, multidose
intervention type: Drug
intervention name: CHF 5074 1x
description: oral tablet, 1x, once a day for 24 months
arm group label: CHF 5074 1x
intervention type: Drug
intervention name: CHF 5074 2x
description: oral tablet, 2x, once a day for 24 months
arm group label: CHF 5074 2x
intervention type: Drug
intervention name: Placebo
description: oral tablet,once a day for 24 months
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 64 Years
healthy volunteers: No
last name: Joel S Ross, MD
role: Principal Investigator
affiliation: Memory Enhancement Center of America
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Nerve Degeneration
mesh term: Cognitive Dysfunction
mesh term: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid