<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/NCT03819699</url>
  </required_header>
  <id_info>
    <org_study_id>18086A</org_study_id>
    <nct_id>NCT03819699</nct_id>
  </id_info>
  <brief_title>Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD</brief_title>
  <official_title>Interventional, Open-label, Multiple-immunisation Study of the Immunogenicity, Pharmacodynamics and Safety of Lu AF20513 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment Due to Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to study the effect of monthly dosing with a single dose of Lu&#xD;
      AF20513, with and without booster vaccine, on antibody response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen&#xD;
      1.&#xD;
&#xD;
      Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly&#xD;
      assigned to two arms:&#xD;
&#xD;
        -  dose regimen 2: 10 patients who will receive one administration of booster vaccine 4&#xD;
           weeks prior to the first IMP administration&#xD;
&#xD;
        -  dose regimen 3: 10 patients who will not receive a booster vaccine&#xD;
&#xD;
      After the PA1, the study consists of the following periods:&#xD;
&#xD;
        -  Screening Period - up to 12 weeks&#xD;
&#xD;
        -  Priming period: 28 weeks, monthly dosing with Lu AF20513&#xD;
&#xD;
        -  Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513&#xD;
&#xD;
        -  Follow-up Period - 4 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    New data: The study was terminated based on new efficacy data from another study&#xD;
  </why_stopped>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">June 27, 2019</completion_date>
  <primary_completion_date type="Actual">June 27, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>From Week 0 to Week 28</time_frame>
    <description>Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>From Week 0 to Week 28</time_frame>
    <description>maximum antibody titre (Cmax) induced upon treatment with Lu AF20513</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Titre response</measure>
    <time_frame>From Week 0 to Week 28</time_frame>
    <description>Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amyloid load</measure>
    <time_frame>From baseline to week 84</time_frame>
    <description>Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Cohort 1 - dose regimen 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1: encompasses patients enrolled prior to the PA1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - dose regimen 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - dose regimen 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2: 10 patients who will not receive a booster vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AF20513</intervention_name>
    <description>Lu AF20513 suspension for injection</description>
    <arm_group_label>Cohort 1 - dose regimen 1</arm_group_label>
    <arm_group_label>Cohort 2 - dose regimen 2</arm_group_label>
    <arm_group_label>Cohort 2 - dose regimen 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>booster vaccine</intervention_name>
    <description>booster vaccine (Cohort 2) - to be administered as per national recommendations</description>
    <arm_group_label>Cohort 2 - dose regimen 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has a diagnosis of AD or Mild Cognitive Impairment (MCI) due to AD.&#xD;
&#xD;
          -  The patient has evidence of an abnormal amyloid and tau status, consistent with AD, by&#xD;
             means of a positive CSF test at screening&#xD;
&#xD;
          -  The patient is aged ≥50 and ≤85 years. If a woman, the patient must be&#xD;
             post-menopausal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has participated in a clinical study where he/she has received passive or&#xD;
             active anti-Aβ immunotherapy or other active immunisation for the treatment of AD.&#xD;
&#xD;
          -  The patient has, in the investigator's opinion, evidence and/or history (clinically or&#xD;
             on MRI) of any clinically significant neurodegenerative disease, serious neurological&#xD;
             disorder, other intracranial or systemic diseases or conditions resulting in a&#xD;
             definite or probable diagnosis of Major or Mild Neuro-Cognitive disorder other than&#xD;
             AD, per DSM-5® criteria.&#xD;
&#xD;
        Other in- and exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@Lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Eastern Finland, Brain Research Unit (FI002)</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Services Turku Oy (FI001)</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital, Huddinge (SE001)</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 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>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03819699
org study id: 18086A
nct id: NCT03819699
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to study the effect of monthly dosing with a single dose of Lu
      AF20513, with and without booster vaccine, on antibody response.
Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen
      1.

      Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly
      assigned to two arms:

        -  dose regimen 2: 10 patients who will receive one administration of booster vaccine 4
           weeks prior to the first IMP administration

        -  dose regimen 3: 10 patients who will not receive a booster vaccine

      After the PA1, the study consists of the following periods:

        -  Screening Period - up to 12 weeks

        -  Priming period: 28 weeks, monthly dosing with Lu AF20513

        -  Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513

        -  Follow-up Period - 4 weeks
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC
time frame: From Week 0 to Week 28
description: Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
measure: Cmax
time frame: From Week 0 to Week 28
description: maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
measure: Titre response
time frame: From Week 0 to Week 28
description: Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment
measure: Amyloid load
time frame: From baseline to week 84
description: Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)
arm group label: Cohort 1 - dose regimen 1
arm group type: Experimental
description: Cohort 1: encompasses patients enrolled prior to the PA1
arm group label: Cohort 2 - dose regimen 2
arm group type: Experimental
description: Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration
arm group label: Cohort 2 - dose regimen 3
arm group type: Experimental
description: Cohort 2: 10 patients who will not receive a booster vaccine
intervention type: Drug
intervention name: Lu AF20513
description: Lu AF20513 suspension for injection
arm group label: Cohort 1 - dose regimen 1
arm group label: Cohort 2 - dose regimen 2
arm group label: Cohort 2 - dose regimen 3
intervention type: Biological
intervention name: booster vaccine
description: booster vaccine (Cohort 2) - to be administered as per national recommendations
arm group label: Cohort 2 - dose regimen 2
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
facility: 
facility: 
facility: 
country: Finland
country: Sweden
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction