<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/NCT01695889</url>
  </required_header>
  <id_info>
    <org_study_id>DEMA-1</org_study_id>
    <nct_id>NCT01695889</nct_id>
  </id_info>
  <brief_title>Is There a Relationship Between Previous Exposure to General Anesthesia and the Development of Alzheimer´s Disease?</brief_title>
  <acronym>DEMA</acronym>
  <official_title>A Case-control Study of Exposure to General Anesthesia and a Diagnosis of Alzheimer´s Disease Later in Life.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare exposure to general anesthesia between cases with a&#xD;
      diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical&#xD;
      records. The investigators wish to explore if there is a relationship between exposure to&#xD;
      general anesthesia and the development of Alzheimer´s disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Exposure to general anesthesia</measure>
    <time_frame>Up to 20 years in retrospect</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exposure to inhaled anesthetics</measure>
    <time_frame>Up to 20 years in retrospect</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">877</enrollment>
  <condition>Alzheimer´s Disease</condition>
  <condition>General Anesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cases from a regional Alzheimer´s disease record. Matched controls from the national&#xD;
        population register.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Alzheimer´s disease&#xD;
&#xD;
          -  Previous exposure to anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to retrieve medical records&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Eintrei, professor</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Linkoping</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Linkoping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>March 24, 2016</last_update_submitted>
  <last_update_submitted_qc>March 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Anna-Karin Strand, MD</investigator_full_name>
    <investigator_title>Specialist in Anaesthesiology and Intensive Care</investigator_title>
  </responsible_party>
  <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 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/NCT01695889
org study id: DEMA-1
nct id: NCT01695889
lead sponsor: 
has dmc: No
The purpose of this study is to compare exposure to general anesthesia between cases with a
      diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical
      records. The investigators wish to explore if there is a relationship between exposure to
      general anesthesia and the development of Alzheimer´s disease.
observational model: Case-Control
time perspective: Retrospective
measure: Exposure to general anesthesia
time frame: Up to 20 years in retrospect
measure: Exposure to inhaled anesthetics
time frame: Up to 20 years in retrospect
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christina Eintrei, professor
role: Study Chair
affiliation: University Hospital Linkoping
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Anna-Karin Strand, MD
investigator title: Specialist in Anaesthesiology and Intensive Care
mesh term: Alzheimer Disease