<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/NCT04464564</url>
  </required_header>
  <id_info>
    <org_study_id>20-AVP-786-307</org_study_id>
    <secondary_id>2020-000799-39</secondary_id>
    <nct_id>NCT04464564</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786&#xD;
      (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the&#xD;
      treatment of agitation in participants with dementia of the Alzheimer's type.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants for this study must have a diagnosis of probable Alzheimer's disease&#xD;
      (AD) and must have clinically significant, moderate/severe agitation secondary to AD.&#xD;
&#xD;
      This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12&#xD;
      weeks of treatment.&#xD;
&#xD;
      Approximately 750 participants will be enrolled at approximately 110 centers worldwide.&#xD;
&#xD;
      Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening&#xD;
      will occur within approximately 4 weeks prior to randomization. Following screening&#xD;
      procedures for assessment of inclusion and exclusion criteria, eligible participants will be&#xD;
      randomized into the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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 to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score</measure>
    <time_frame>Baseline; Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation</measure>
    <time_frame>Baseline; Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Agitation in Patients With Dementia of the Alzheimer's Type</condition>
  <arm_group>
    <arm_group_label>AVP-786</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AVP-786</intervention_name>
    <description>oral capsules</description>
    <arm_group_label>AVP-786</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with a diagnosis of probable Alzheimer's disease according to the 2011&#xD;
             Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria&#xD;
&#xD;
          -  Participants with clinically significant, moderate-to-severe agitation for at least 2&#xD;
             weeks prior to Screening that interferes with daily routine per the Investigator's&#xD;
             judgment&#xD;
&#xD;
          -  Participants who require pharmacotherapy for the treatment of agitation per the&#xD;
             Investigator's judgment after an evaluation of reversible factors and a course of&#xD;
             nonpharmacological interventions&#xD;
&#xD;
          -  Diagnosis of agitation must meet the International Psychogeriatric Association (IPA)&#xD;
             provisional definition of agitation.&#xD;
&#xD;
          -  Participants meeting an additional predetermined blinded eligibility criterion, which&#xD;
             will remain blinded to the clinical study site Investigators and staff&#xD;
&#xD;
          -  Participants with a reliable caregiver who is able and willing to comply with all&#xD;
             study procedures, including adherence to administering study drug and not&#xD;
             administering any prohibited medications during the course of the study, and who&#xD;
             spends a minimum of 2 hours per day for 4 days per week with the participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular&#xD;
             dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)&#xD;
&#xD;
          -  Participants with symptoms of agitation that are not secondary to Alzheimer's dementia&#xD;
             (e.g., secondary to pain, other psychiatric disorder, or delirium)&#xD;
&#xD;
          -  Participants with co-existent clinically significant or unstable systemic diseases&#xD;
             that could confound the interpretation of the safety results of the study (e.g.,&#xD;
             malignancy [except skin basal-cell carcinoma], poorly controlled diabetes, poorly&#xD;
             controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable&#xD;
             ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)&#xD;
&#xD;
          -  Participants with myasthenia gravis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Otsuka Call Center</last_name>
    <phone>844-687-8522</phone>
    <email>OtsukaRMReconciliation@rmpdc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-047</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-059</name>
      <address>
        <city>Lafayette</city>
        <state>California</state>
        <zip>94549</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-048</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-046</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-025</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-070</name>
      <address>
        <city>Apopka</city>
        <state>Florida</state>
        <zip>32703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-055</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-066</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Lady Lake</city>
        <state>Florida</state>
        <zip>32159</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-041</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-049</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site# 840-061</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83646</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-030</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-073</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02459</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-014</name>
      <address>
        <city>Bloomfield Township</city>
        <state>Michigan</state>
        <zip>48302</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-022</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-024</name>
      <address>
        <city>O'Fallon</city>
        <state>Missouri</state>
        <zip>63368</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-063</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-043</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-035</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-053</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-072</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77077</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22311</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #056-004</name>
      <address>
        <city>Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #056-003</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 056-002</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site# 124-007</name>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T 4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1M 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G3K 2P8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #124-002</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1L 0H8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #152-002</name>
      <address>
        <city>Antofagasta</city>
        <zip>1270244</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 152-005</name>
      <address>
        <city>Independencia</city>
        <zip>8380456</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #152-001</name>
      <address>
        <city>Santiago de Chile</city>
        <zip>7500710</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #152-006</name>
      <address>
        <city>Santiago de Chile</city>
        <zip>9120000</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #152-003</name>
      <address>
        <city>Santiago</city>
        <zip>7560356</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bogota</city>
        <state>Columbia</state>
        <zip>111166</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Pereira</city>
        <state>Columbia</state>
        <zip>1111</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Florida Blanca</city>
        <state>Santander</state>
        <zip>111511</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bello</city>
        <zip>051050</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bogota</city>
        <zip>110231</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bogotá</city>
        <zip>110231</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site# 191-006</name>
      <address>
        <city>Rijeka</city>
        <zip>51000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site# 191-001</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #191-003</name>
      <address>
        <city>Zagreb</city>
        <zip>1000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #191-005</name>
      <address>
        <city>Zagreb</city>
        <zip>HR 10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #191-002</name>
      <address>
        <city>Zagreb</city>
        <zip>HR-10090</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #191-004</name>
      <address>
        <city>Zagreb</city>
        <zip>HRV-10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Gyöngyös</city>
        <state>Heves</state>
        <zip>3200</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #1</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #2</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #348-004</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #484-008</name>
      <address>
        <city>Merida</city>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 484-004</name>
      <address>
        <city>Mexico City</city>
        <zip>7000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #484-006</name>
      <address>
        <city>Monterrey</city>
        <zip>64310</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #484-005</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 484-003</name>
      <address>
        <city>Monterrey</city>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #484-010</name>
      <address>
        <city>Saltillo</city>
        <zip>25020</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 484-002</name>
      <address>
        <city>Sinaloa</city>
        <zip>80020</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #484-009</name>
      <address>
        <city>Tlalnepantla</city>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site #528-001</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081GN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #703-009</name>
      <address>
        <city>Dubnica Nad Váhom</city>
        <state>Bratislavský Kraj</state>
        <zip>01851</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Rimavska Sobota</city>
        <state>Sobota</state>
        <zip>97901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #703-006</name>
      <address>
        <city>Banská Bystrica</city>
        <zip>97404</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bardejov</city>
        <zip>08501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #703-005</name>
      <address>
        <city>Košice</city>
        <zip>04001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Trencin</city>
        <zip>91108</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Vranov Nad Topľou</city>
        <zip>09301</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Begunje na Gorenjskem</city>
        <zip>4275</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Ljubljana</city>
        <zip>1260</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #705-005</name>
      <address>
        <city>Maribor</city>
        <zip>2000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #705-001</name>
      <address>
        <city>Nova Gorica</city>
        <zip>52905000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #724-010</name>
      <address>
        <city>Burgos</city>
        <zip>09006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 724-007</name>
      <address>
        <city>Coslada</city>
        <zip>28882</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28049</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Sant Cugat del Vallès</city>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Terrassa</city>
        <zip>08222</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Hungary</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Agitation</keyword>
  <keyword>Dementia of the Alzheimer's type</keyword>
  <keyword>Alzheimer's disease</keyword>
  <keyword>AVP-786</keyword>
  <keyword>Deudextromethorphan hydrobromide</keyword>
  <keyword>Quinidine sulfate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Psychomotor Agitation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.</ipd_time_frame>
    <ipd_access_criteria>Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/</ipd_access_criteria>
    <ipd_url>https://clinical-trials.otsuka.com</ipd_url>
  </patient_data>
  <!-- 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/NCT04464564
org study id: 20-AVP-786-307
secondary id: 2020-000799-39
nct id: NCT04464564
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786
      (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the
      treatment of agitation in participants with dementia of the Alzheimer's type.
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease
      (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

      This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12
      weeks of treatment.

      Approximately 750 participants will be enrolled at approximately 110 centers worldwide.

      Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening
      will occur within approximately 4 weeks prior to randomization. Following screening
      procedures for assessment of inclusion and exclusion criteria, eligible participants will be
      randomized into the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
time frame: Baseline; Week 12
measure: Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation
time frame: Baseline; Week 12
arm group label: AVP-786
arm group type: Experimental
description: Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
intervention type: Drug
intervention name: AVP-786
description: oral capsules
arm group label: AVP-786
intervention type: Drug
intervention name: Placebo
description: oral capsules
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Otsuka Call Center
phone: 844-687-8522
email: OtsukaRMReconciliation@rmpdc.org
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Belgium
country: Canada
country: Chile
country: Colombia
country: Croatia
country: Hungary
country: Mexico
country: Netherlands
country: Slovakia
country: Slovenia
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Dementia
mesh term: Alzheimer Disease
mesh term: Psychomotor Agitation
sharing ipd: Yes
ipd description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
ipd access criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
ipd url: https://clinical-trials.otsuka.com