<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/NCT03307993</url>
  </required_header>
  <id_info>
    <org_study_id>17475A</org_study_id>
    <nct_id>NCT03307993</nct_id>
  </id_info>
  <brief_title>Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease</brief_title>
  <official_title>Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With 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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's&#xD;
      disease (AD)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated for strategic reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">February 19, 2018</completion_date>
  <primary_completion_date type="Actual">February 19, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5-HT6 Receptor Occupancy (RO)</measure>
    <time_frame>Treatment day 10 (24 hours post dose)</time_frame>
    <description>RO in the region of interest will be calculated as 100 × (1 - BPND(treatment) / BPND(baseline)) where BPND is the binding potential</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Idalopirdine plasma concentration (CPET)</measure>
    <time_frame>Prior to and after PET scan on treatment day 10</time_frame>
    <description>CPET is the concentration at the time of PET scan, defined as (CprePET + CpostPET) / 2 (average of the pre- and post-PET scanning measurements).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Idalopirdine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Idalopirdine 60 mg once daily for 10 day (up to 14 days possible), adjunct to donezepil (patients individualized maintenance dose)&#xD;
If high receptor occupancy cannot be verified, the receptor occupancy following a higher dose (up to 60 mg twice daily for 10-14 days) will be assessed in Cohort 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idalopirdine</intervention_name>
    <description>Idalopirdine 60-120 mg daily dose</description>
    <arm_group_label>Idalopirdine</arm_group_label>
    <other_name>Lu AE58054</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has probable AD diagnosed according to National Institute of Neurological&#xD;
             and Communicative Disorders and Stroke and the Alzheimer's disease and Related&#xD;
             Disorders Association (NINCDS-ADRDA) criteria.&#xD;
&#xD;
          -  The patient has had a positive amyloid PET scan, which in the opinion of the principal&#xD;
             investigator is consistent with a diagnosis of AD.&#xD;
&#xD;
          -  The patient has a Mini Mental State Examination (MMSE) score at screening of at least&#xD;
             15 and no greater than 22.&#xD;
&#xD;
          -  The patient has a knowledgeable and reliable caregiver who will accompany the patient&#xD;
             to all clinic visits during the study and answer questions about the patient.&#xD;
&#xD;
          -  The patient is a man or woman of at least 50 years of age and has a body mass index&#xD;
             (BMI) ≥ 18.5 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has evidence of any clinically significant neurodegenerative disease, or&#xD;
             other serious neurological disorders other than AD including but not limited to Lewy&#xD;
             body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease,&#xD;
             major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or&#xD;
             systemic medical diseases that are, in the investigator's opinion, likely to affect&#xD;
             central nervous system functioning and may influence the outcome or analysis of the&#xD;
             scan results.&#xD;
&#xD;
          -  The patient is, in the investigator's opinion, unlikely to comply with the protocol or&#xD;
             is unsuitable for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</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>H. Lundbeck A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lu AE58054</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307993
org study id: 17475A
nct id: NCT03307993
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's
      disease (AD)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 5-HT6 Receptor Occupancy (RO)
time frame: Treatment day 10 (24 hours post dose)
description: RO in the region of interest will be calculated as 100 × (1 - BPND(treatment) / BPND(baseline)) where BPND is the binding potential
measure: Idalopirdine plasma concentration (CPET)
time frame: Prior to and after PET scan on treatment day 10
description: CPET is the concentration at the time of PET scan, defined as (CprePET + CpostPET) / 2 (average of the pre- and post-PET scanning measurements).
arm group label: Idalopirdine
arm group type: Experimental
description: Idalopirdine 60 mg once daily for 10 day (up to 14 days possible), adjunct to donezepil (patients individualized maintenance dose)
If high receptor occupancy cannot be verified, the receptor occupancy following a higher dose (up to 60 mg twice daily for 10-14 days) will be assessed in Cohort 2.
intervention type: Drug
intervention name: Idalopirdine
description: Idalopirdine 60-120 mg daily dose
arm group label: Idalopirdine
other name: Lu AE58054
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: H. Lundbeck A/S
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine