<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/NCT02185053</url>
  </required_header>
  <id_info>
    <org_study_id>CPC-001-07</org_study_id>
    <nct_id>NCT02185053</nct_id>
  </id_info>
  <brief_title>A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia</brief_title>
  <official_title>A Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients With Alzheimer's Disease Type Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chase Pharmaceuticals Corporation, an affiliate of Allergan plc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chase Pharmaceuticals Corporation, an affiliate of Allergan plc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple&#xD;
      Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with&#xD;
      Alzheimer's Disease Type Dementia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2014</start_date>
  <completion_date type="Actual">July 31, 2016</completion_date>
  <primary_completion_date type="Actual">July 31, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Donepezil Maximum Tolerated Dose (MTD)</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any TEAEs</measure>
    <time_frame>6 months</time_frame>
    <description>Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose</measure>
    <time_frame>Day 1 (baseline) to end of study</time_frame>
    <description>Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>CPC-201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPC-201</intervention_name>
    <arm_group_label>CPC-201</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 50 - 79 years inclusive.&#xD;
&#xD;
          -  Meeting the diagnosis of probable Alzheimer's Disease&#xD;
&#xD;
          -  Of moderate severity (Mini-Mental Status Exam [MMSE] score 10 - 20 inclusive).&#xD;
&#xD;
          -  Patients must be in generally good health as indicated by their medical history and&#xD;
             physical examination, vital signs, electrocardiogram (ECG), and standard laboratory&#xD;
             tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of child bearing potential.&#xD;
&#xD;
          -  History or presence of a seizure disorder.&#xD;
&#xD;
          -  History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive&#xD;
             pulmonary disease.&#xD;
&#xD;
          -  History or presence of bladder outflow obstruction, gastrointestinal obstructive&#xD;
             disorder or reduced GI motility, or narrow-angle glaucoma.&#xD;
&#xD;
          -  History or presence of gastrointestinal, hepatic, or renal disease, or other condition&#xD;
             known to interfere with the absorption, distribution, metabolism or excretion of&#xD;
             drugs.&#xD;
&#xD;
          -  History or presence of myasthenia.&#xD;
&#xD;
          -  Known hypersensitivity to donepezil, solifenacin or related drugs.&#xD;
&#xD;
          -  Any other clinically relevant acute or chronic diseases which could interfere with&#xD;
             patients' safety during the trial, or expose them to undue risk, or which could&#xD;
             interfere with study objectives.&#xD;
&#xD;
          -  Patients who have participated in another clinical trial with an investigational drug&#xD;
             within previous 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn James</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CPC1</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>May 11, 2020</results_first_submitted>
  <results_first_submitted_qc>May 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2020</results_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>Dementia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Solifenacin Dose Escalation</title>
          <description>Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day)</description>
        </group>
        <group group_id="P2">
          <title>Donepezil Dose Escalation</title>
          <description>Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.</description>
        </group>
        <group group_id="P3">
          <title>Donepezil Dose Maintenance</title>
          <description>Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Solifenacin Dose Escalation Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Cardiac symptoms</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meeting eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Donepezil Dose Escalation Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Cardiac symptoms</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meeting eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Donepezil Dose Maintenance Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Cardiac symptoms</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Safety Population</title>
          <description>All subjects who received at least one dose of any study drug.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.1" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Donepezil Maximum Tolerated Dose (MTD)</title>
        <description>Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Donepezil Dose Escalation</title>
            <description>Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.</description>
          </group>
          <group group_id="O2">
            <title>Donepezil Dose Maintenance</title>
            <description>Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Donepezil Maximum Tolerated Dose (MTD)</title>
          <description>Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 mg/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 mg/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 mg/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mg/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>35 mg/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 mg/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any TEAEs</title>
        <description>Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.</description>
        <time_frame>6 months</time_frame>
        <population>All subjects those who received at least one dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Safety Population</title>
            <description>All subjects who received at least one dose of any study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any TEAEs</title>
          <description>Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.</description>
          <population>All subjects those who received at least one dose of any study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious Adverse Events (SAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose</title>
        <description>Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.</description>
        <time_frame>Day 1 (baseline) to end of study</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Solifenain Dose Escalation</title>
            <description>Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day)</description>
          </group>
          <group group_id="O2">
            <title>Donepezil Dose Escalation</title>
            <description>Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.</description>
          </group>
          <group group_id="O3">
            <title>Donepezil Dose Maintenance</title>
            <description>Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose</title>
          <description>Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Donepezil Concentration pre-dose (ng/mL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" spread="20.27"/>
                    <measurement group_id="O2" value="184.2" spread="65.95"/>
                    <measurement group_id="O3" value="188.1" spread="64.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Donepezil Concentration 4 hour post-dose (ng/mL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.2" spread="21.58"/>
                    <measurement group_id="O2" value="257.5" spread="80.56"/>
                    <measurement group_id="O3" value="269.2" spread="80.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Safety Population</title>
          <description>All subjects who received at least one dose of any study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA, Version 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric volvulus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA, Version 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02185053
org study id: CPC-001-07
nct id: NCT02185053
lead sponsor: 
has dmc: Yes
This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple
      Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with
      Alzheimer's Disease Type Dementia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Donepezil Maximum Tolerated Dose (MTD)
time frame: 6 months
description: Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.
measure: Number of Subjects With Any TEAEs
time frame: 6 months
description: Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.
measure: Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
time frame: Day 1 (baseline) to end of study
description: Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.
arm group label: CPC-201
arm group type: Experimental
intervention type: Drug
intervention name: CPC-201
arm group label: CPC-201
criteria: 
gender: All
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: No
last name: Lynn James
role: Study Director
affiliation: Allergan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 