<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/NCT02260674</url>
  </required_header>
  <id_info>
    <org_study_id>CR105240</org_study_id>
    <secondary_id>54861911ALZ2002</secondary_id>
    <secondary_id>2014-002159-24</secondary_id>
    <nct_id>NCT02260674</nct_id>
  </id_info>
  <brief_title>A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease</brief_title>
  <official_title>A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects With Early Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term safety and tolerability of&#xD;
      JNJ-54861911 during 6 months of treatment in participants with early (predementia)&#xD;
      alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious&#xD;
      onset of dementia, impairment of memory, judgment, attention span, and problem solving skills&#xD;
      are followed by severe apraxias and a global loss of cognitive abilities]).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind (neither the researchers nor the participants know what treatment the&#xD;
      participant is receiving), placebo-controlled (an inactive substance; a pretend treatment&#xD;
      [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has&#xD;
      a real effect), randomized (study drug assigned by chance), multi-center (when more than one&#xD;
      hospital or medical school team work on a medical research study), parallel-group study. The&#xD;
      study consists of 3 Parts; Screening Phase of 90 days, double-blind Treatment Phase of 6&#xD;
      months and Follow-up Phase of 7 to 28 days following the last dose in Month 6. Eligible&#xD;
      participants in the early (predementia) AD spectrum will be randomized to either Treatment&#xD;
      group 1, 2 or placebo and participants who previously participated in study 54861911ALZ1005&#xD;
      will be enrolled in this study and will receive the same treatment as in study&#xD;
      54861911ALZ1005. The study duration for each participant will be approximately 10 months.&#xD;
      Blood and cerebrospinal fluid (CSF) samples will be collected to evaluate the plasma&#xD;
      pharmacokinetics of JNJ-54861911, as well as amyloid beta fragments. Participants' safety&#xD;
      will be monitored throughout the study, including magnetic resonance imaging (MRI) and&#xD;
      cognitive measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>up to 10 months</time_frame>
    <description>An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship Between Dose and Exposure of JNJ-54861911 With Safety</measure>
    <time_frame>Month 1 up to Month 6</time_frame>
    <description>Plasma and, if possible, CSF measurements will be taken to measure the concentration of JNJ-54861911. Population pharmacokinetic modeling (statistical modeling) will be used to derive individual pharmacokinetic parameters (e.g. Cmax, AUCtau, Tmax) in plasma and, if possible, in CSF. Incidence of adverse events and their timing of onset will be examined with regard to these concentrations to assess potential relationships between safety and exposure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels and Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The CSF samples will be obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length are produced by cleavage of the APP by beta-secretase (BACE) and the gamma-secretase complex in the brain and excreted into CSF. For participants, who participated previously in study 54861911ALZ1005, the baseline CSF sample taken during that study may be used as baseline in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels</measure>
    <time_frame>Baseline and Month 6 (Day 168)</time_frame>
    <description>Plasma samples will be obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length are produced by cleavage of the APP by beta-secretase (BACE) and the gamma-secretase complex in the different peripheral tissues, including white blood cells and can be measured in Plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety</measure>
    <time_frame>Month 1 up to Month 6</time_frame>
    <description>ABeta species and sAPP fragments in plasma and CSF will be measured. Incidence of adverse events and their timing of onset will be examined with regard to these concentrations to assess potential relationships between safety and changes in the ABeta species and sAPP fragments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of JNJ-54861911</measure>
    <time_frame>Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168</time_frame>
    <description>The Cmax is the maximum observed plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach the Maximum Plasma or CSF concentration (Tmax)</measure>
    <time_frame>Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168</time_frame>
    <description>The Tmax is the time to reach the maximum plasma or CSF concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau)</measure>
    <time_frame>Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168</time_frame>
    <description>AUCtau is the area under the plasma/CSF concentration-time curve from time 0 to tau hours post dosing. Time tau is the dosing interval.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Treatment Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will self-administer JNJ-54861911, two tablets of 5 milligram (mg) each for a total of 10 mg, orally, once daily, from Day 1 until Month 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-54861911, 10 milligram (mg)</intervention_name>
    <description>Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1.</description>
    <arm_group_label>Treatment Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-54861911, 50 mg</intervention_name>
    <description>Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2.</description>
    <arm_group_label>Treatment Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants in the early alzheimer's disease (AD) spectrum must have a global&#xD;
             Clinical Dementia Rating Scale( CDR) score of 0 (asymptomatic at risk for AD) to 0.5&#xD;
             prodromal AD (pAD) inclusive&#xD;
&#xD;
          -  Participants must have evidence of amyloid pathology by means of either: a) low&#xD;
             Cerebrospinal Fluid (CSF) ABeta 1-42 levels at screening; b) a positive amyloid&#xD;
             positron emission tomography (PET) scan at screening (depending on the site's PET&#xD;
             capability) by visual read&#xD;
&#xD;
          -  Participants must have a body mass index between 18 and 35 kilogram per square meter&#xD;
             (kg/m^2), inclusive, at screening&#xD;
&#xD;
          -  Participants must be otherwise healthy for their age group or medically stable with or&#xD;
             without medication on the basis of physical examination, medical history, vital signs,&#xD;
             and 12-lead ECG performed at screening or at baseline. If there are abnormalities,&#xD;
             they must be consistent with the underlying illness in the study population and not a&#xD;
             potential cause of cognitive impairment, with written concurrence with the sponsor's&#xD;
             medical monitor&#xD;
&#xD;
          -  Before randomization, a woman must be not of childbearing potential: postmenopausal&#xD;
             (greater than or equal to [&gt;=] 50 years of age with amenorrhea for at least 12 months;&#xD;
             permanently sterilized [e.g., tubal occlusion, hysterectomy, bilateral&#xD;
             salpingectomy]); or otherwise be incapable of pregnancy. In case of questionable&#xD;
             status qualified personal of the sponsor should be consulted to decide on the&#xD;
             potential for inclusion of the participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has evidence of any brain disease, other than potential very early signs&#xD;
             of AD (e.g. mild hippocampal atrophy) or typical age-related changes (e.g. mild white&#xD;
             matter hyperintensity on magnetic resonance imaging [MRI]) or any other abnormality&#xD;
             (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive&#xD;
             deficit (including, but not limited to vascular encephalopathy or strokes including&#xD;
             lacuna's (as imaged by cerebral MRI) and Major Depression (as defined by most current&#xD;
             Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria)&#xD;
&#xD;
          -  Participant has evidence of familial autosomal dominant AD. (Inclusion can be made&#xD;
             upon written confirmation by sponsor, when the mutation is known and deemed not to be&#xD;
             modulating Beta-secretase [BACE] cleavage)&#xD;
&#xD;
          -  Participant with history or presence of significant depression as defined by the most&#xD;
             current DSM criteria&#xD;
&#xD;
          -  Participant has a clinically significant abnormal physical- or neurological&#xD;
             examination, vital signs at screening or baseline (Day 1 predose)&#xD;
&#xD;
          -  Participant has a history of or current liver or renal insufficiency; clinically&#xD;
             significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic,&#xD;
             rheumatologic, psychiatric, or metabolic disturbances (e.g. unstable situation needing&#xD;
             monitoring or regular dose adaptations)&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hoboken</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montpellier Cedex 5</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg N/A</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Luebeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Terrasa Barcelona N/A</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mölndal</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <disposition_first_submitted>March 1, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>March 1, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 3, 2017</disposition_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>JNJ-54861911</keyword>
  <keyword>Placebo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02260674
org study id: CR105240
secondary id: 54861911ALZ2002
secondary id: 2014-002159-24
nct id: NCT02260674
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the long-term safety and tolerability of
      JNJ-54861911 during 6 months of treatment in participants with early (predementia)
      alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious
      onset of dementia, impairment of memory, judgment, attention span, and problem solving skills
      are followed by severe apraxias and a global loss of cognitive abilities]).
This is a double-blind (neither the researchers nor the participants know what treatment the
      participant is receiving), placebo-controlled (an inactive substance; a pretend treatment
      [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has
      a real effect), randomized (study drug assigned by chance), multi-center (when more than one
      hospital or medical school team work on a medical research study), parallel-group study. The
      study consists of 3 Parts; Screening Phase of 90 days, double-blind Treatment Phase of 6
      months and Follow-up Phase of 7 to 28 days following the last dose in Month 6. Eligible
      participants in the early (predementia) AD spectrum will be randomized to either Treatment
      group 1, 2 or placebo and participants who previously participated in study 54861911ALZ1005
      will be enrolled in this study and will receive the same treatment as in study
      54861911ALZ1005. The study duration for each participant will be approximately 10 months.
      Blood and cerebrospinal fluid (CSF) samples will be collected to evaluate the plasma
      pharmacokinetics of JNJ-54861911, as well as amyloid beta fragments. Participants' safety
      will be monitored throughout the study, including magnetic resonance imaging (MRI) and
      cognitive measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: up to 10 months
description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
measure: Relationship Between Dose and Exposure of JNJ-54861911 With Safety
time frame: Month 1 up to Month 6
description: Plasma and, if possible, CSF measurements will be taken to measure the concentration of JNJ-54861911. Population pharmacokinetic modeling (statistical modeling) will be used to derive individual pharmacokinetic parameters (e.g. Cmax, AUCtau, Tmax) in plasma and, if possible, in CSF. Incidence of adverse events and their timing of onset will be examined with regard to these concentrations to assess potential relationships between safety and exposure.
measure: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels and Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels
time frame: Baseline and Month 6
description: The CSF samples will be obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length are produced by cleavage of the APP by beta-secretase (BACE) and the gamma-secretase complex in the brain and excreted into CSF. For participants, who participated previously in study 54861911ALZ1005, the baseline CSF sample taken during that study may be used as baseline in this study.
measure: Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels
time frame: Baseline and Month 6 (Day 168)
description: Plasma samples will be obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length are produced by cleavage of the APP by beta-secretase (BACE) and the gamma-secretase complex in the different peripheral tissues, including white blood cells and can be measured in Plasma.
measure: Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety
time frame: Month 1 up to Month 6
description: ABeta species and sAPP fragments in plasma and CSF will be measured. Incidence of adverse events and their timing of onset will be examined with regard to these concentrations to assess potential relationships between safety and changes in the ABeta species and sAPP fragments.
measure: Maximum Plasma Concentration (Cmax) of JNJ-54861911
time frame: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168
description: The Cmax is the maximum observed plasma concentration.
measure: Time to Reach the Maximum Plasma or CSF concentration (Tmax)
time frame: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168
description: The Tmax is the time to reach the maximum plasma or CSF concentration.
measure: Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau)
time frame: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168
description: AUCtau is the area under the plasma/CSF concentration-time curve from time 0 to tau hours post dosing. Time tau is the dosing interval.
arm group label: Treatment Group 1
arm group type: Experimental
description: Participants will self-administer JNJ-54861911, two tablets of 5 milligram (mg) each for a total of 10 mg, orally, once daily, from Day 1 until Month 6.
arm group label: Treatment Group 2
arm group type: Experimental
description: Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6.
intervention type: Drug
intervention name: JNJ-54861911, 10 milligram (mg)
description: Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1.
arm group label: Treatment Group 1
intervention type: Drug
intervention name: JNJ-54861911, 50 mg
description: Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2.
arm group label: Treatment Group 2
intervention type: Drug
intervention name: Placebo
description: Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group.
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
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country: Belgium
country: France
country: Germany
country: Netherlands
country: Spain
country: Sweden
responsible party type: Sponsor
mesh term: Alzheimer Disease