<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/NCT04408755</url>
  </required_header>
  <id_info>
    <org_study_id>20-AVP-786-306</org_study_id>
    <secondary_id>2020-000798-26</secondary_id>
    <nct_id>NCT04408755</nct_id>
  </id_info>
  <brief_title>Assessment of 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">July 8, 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>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-081</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-013</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-064</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-056</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</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>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34744</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-069</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</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>33126</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>33175</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>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-041</name>
      <address>
        <city>Palm Beach Gardens</city>
        <state>Florida</state>
        <zip>33410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33064</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-079</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-046</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 840-001</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 #840-049</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-033</name>
      <address>
        <city>Mount Arlington</city>
        <state>New Jersey</state>
        <zip>07856</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>West Long Branch</city>
        <state>New Jersey</state>
        <zip>07764</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-072</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-030</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-028</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-061</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73012</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-018</name>
      <address>
        <city>Moosic</city>
        <state>Pennsylvania</state>
        <zip>18507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77381</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #840-025</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1408</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Varna</city>
        <zip>9020</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site # 208-001</name>
      <address>
        <city>Aalborg</city>
        <state>Region Nordjylland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #1</name>
      <address>
        <city>Tallinn</city>
        <zip>11315</zip>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #2</name>
      <address>
        <city>Tallinn</city>
        <zip>11315</zip>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bad Homburg Vor Der Höhe</city>
        <state>Hessen</state>
        <zip>61348</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #276-012</name>
      <address>
        <city>Gera</city>
        <state>Thüringen</state>
        <zip>935</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Mittweida</city>
        <zip>09648</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Munich</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Westerstede</city>
        <zip>26655</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #300-001</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site# 300-005</name>
      <address>
        <city>Athens</city>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #300-002</name>
      <address>
        <city>Maroúsi</city>
        <zip>15123</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #300-003</name>
      <address>
        <city>Thessaloníki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-Pomorskie</state>
        <zip>85-023</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-093</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-163</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Kielce</city>
        <zip>25-411</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-064</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #616-010</name>
      <address>
        <city>Lublin</city>
        <zip>20-080</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-369</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Poznan</city>
        <zip>61-853</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Pruszcz Gdanski</city>
        <zip>83-000</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Siemianowice Śląskie</city>
        <zip>41-100</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-737</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Santa Maria Da Feira</city>
        <state>Aveiro</state>
        <zip>4520-211</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Matosinhos</city>
        <zip>4520-211</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Torres Vedras</city>
        <zip>2560-280</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Bayamon</city>
        <zip>00961</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site #630-003</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Kiev</city>
        <zip>8631</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04080</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Lviv</city>
        <zip>79021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Aylesbury</city>
        <zip>HP18 0LX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Blandford Forum</city>
        <zip>DT11 7DD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Crowborough</city>
        <zip>TN61NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Fulwood</city>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site# 826-006</name>
      <address>
        <city>Manchester</city>
        <zip>M25 3BL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site</name>
      <address>
        <city>Motherwell</city>
        <zip>ML1 4UF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 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/NCT04408755
org study id: 20-AVP-786-306
secondary id: 2020-000798-26
nct id: NCT04408755
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: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
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: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not 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: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
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: Active, not recruiting
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: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Bulgaria
country: Denmark
country: Estonia
country: Germany
country: Greece
country: Poland
country: Portugal
country: Puerto Rico
country: Ukraine
country: United Kingdom
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