<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/NCT04436341</url>
  </required_header>
  <id_info>
    <org_study_id>H-17035751</org_study_id>
    <nct_id>NCT04436341</nct_id>
  </id_info>
  <brief_title>Epileptic Activity in Patients With Alzheimer's Disease and Lewy Body Dementia</brief_title>
  <acronym>AD-LBD-EPI</acronym>
  <official_title>Epileptic Activity in Patients With Alzheimer's Disease and Lewy Body Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Dementia Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>T&amp;W Engineering A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Danish Dementia Research Centre</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current study, the investigators will examine the extent of subclinical epileptic&#xD;
      activity in patients with Alzheimer's disease and patients with Lewy body dementia as&#xD;
      compared to healthy elderly controls. The participants will wear a new device called&#xD;
      &quot;ear-EEG&quot;, which makes it possible to record EEG for longer periods of time while at home.&#xD;
      Furthermore, the investigators want to investigate whether there is an association between&#xD;
      subclinical epileptic activity and the cerebral blood flow as measured with functional MRI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 20, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility study: Investigate whether patients with Alzheimer's disease are able wear ear-EEG for longer than 24 hours during a 48 hours period</measure>
    <time_frame>8 months</time_frame>
    <description>If it is possible for patients with Alzheimer's disease to wear ear-EEG for at least 24 hours including 5 hours of sleep during a 48 hours period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Epileptic activity in patients with Alzheimer's disease and Lewy body dementia as compared to healthy elderly controls</measure>
    <time_frame>2 years</time_frame>
    <description>Compare the prevalence and type of paroxysmal activity as measured with the ear-EEG in patients with Alzheimer's disease and Lewy body dementia as compared to healthy elderly controls</description>
  </primary_outcome>
  <other_outcome>
    <measure>The correlation between cerebral blood flow and paroxysmal acitivity</measure>
    <time_frame>2 years</time_frame>
    <description>Compare the amount of paroxysmal activity as measured with ear-EEG and the cerebral blood flow (rCBF) as measured with arterial spin labeling fMRI in patients with Alzheimer's disease and Lewy body dementia</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Lewy Body Disease</condition>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Patients with Alzheimer's disease</arm_group_label>
    <description>No treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Lewy body dementia</arm_group_label>
    <description>No treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>No treatment interventions. Investigations: physical examination, ear-EEG cranial MR, cognitive tests, blood samples</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A total of 13 mL of blood will be collected from each participant. Afterwards, the blood will&#xD;
      be centrifuged and the serum, plasma and the white blood cells will be extracted. These&#xD;
      samples will be stored in the Danish Dementia Biobank.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In the first part of the study (feasibility), the investigators will include 10 patients&#xD;
        with Alzheimer's disease from the memory clinics at Rigshospitalet and Zealand University&#xD;
        Hospital - Roskilde. In the main study, the investigators will include an additional 40&#xD;
        patients with Alzheimer's disease, 20 patients with Lewy body dementia, and 50 healthy&#xD;
        controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (Alzheimer's disease):&#xD;
&#xD;
          -  Meet the criteria for probable Alzheimer's disease with amnestic presentation as&#xD;
             described in the NIA-AA criteria (McKhann 2011)&#xD;
&#xD;
          -  The diagnosis has been made by either a neurologist, psychiatrist or a geriatrician at&#xD;
             the memory clinic at Rigshospitalet or Zealand University Hospital&#xD;
&#xD;
          -  The participant is between 50 and 90 years old&#xD;
&#xD;
          -  The MMSE score is between 16-28&#xD;
&#xD;
          -  The participant does not wear a hearing aid&#xD;
&#xD;
          -  The participant is a native Danish speaker&#xD;
&#xD;
          -  The participant has at least attended school for 7 years&#xD;
&#xD;
          -  The participants' hearing and vision is sufficient to participate in&#xD;
             neuropsychological tests&#xD;
&#xD;
          -  The participants' general condition of health allows that the participant can&#xD;
             cooperate with the trial&#xD;
&#xD;
          -  The participant does not suffer from psychiatric diseases (except mild depressive&#xD;
             symptoms or mild depression) or neurological diseases that affect the brain other than&#xD;
             Alzheimer's disease&#xD;
&#xD;
          -  The treatment with anti-dementia medication or SSRI drugs have been given in stable&#xD;
             dose for at least 3 months up to the inclusion and the doctor including the&#xD;
             participant estimates that treatment will not change within the next 6 months&#xD;
&#xD;
          -  No overuse of alcohol or intake of illegal drugs within the last 2 years&#xD;
&#xD;
          -  The participant has previously undergone a CT or MRI scan, which is compatible with&#xD;
             Alzheimer's disease&#xD;
&#xD;
          -  The participant does not have any contraindications for MRI or MRI contrast&#xD;
&#xD;
          -  The participant is living with another person, who is willing to take part in the&#xD;
             trial, and who is together with the person long enough to observe the behavior (if any&#xD;
             epileptic activity should arise)&#xD;
&#xD;
        Exclusion Criteria (Alzheimer's disease):&#xD;
&#xD;
          -  Diagnosis of epilepsy prior to the diagnosis of Alzheimer's disease was made&#xD;
&#xD;
          -  Other focal pathology in the hippocampus for example hippocampal sclerosis&#xD;
&#xD;
          -  The person living with the participant is not able to participate (e.g. due to a&#xD;
             serious disease or disability) in the clinical visits or able to register behavior&#xD;
             suspected of epilepsy&#xD;
&#xD;
          -  The participant is living in a nursing home&#xD;
&#xD;
          -  The participant is treated with antiepileptic medication, tricyclic antidepressants or&#xD;
             antipsychotics&#xD;
&#xD;
          -  Daily or nearly daily intake of medication known to have an anticholinergic or an&#xD;
             adrenergic effect, which is suspected to affect the cognitive abilities or the EEG&#xD;
&#xD;
          -  Large brain infarctions or more than 4 lacunar infarcts&#xD;
&#xD;
          -  The participants is suffering from uncontrollable movements of the face as for example&#xD;
             oral dyskinesia&#xD;
&#xD;
        Inclusion Criteria (Lewy body dementia):&#xD;
&#xD;
          -  Meet the criteria for Lewy body dementia as described in dementia with Lewy body&#xD;
             consortium (McKeith 2017)&#xD;
&#xD;
          -  The diagnose has been made by either a neurologist, psychiatrist or a geriatrician at&#xD;
             the memory clinic at Rigshospitalet or Zealand University Hospital&#xD;
&#xD;
          -  The participant is between 50 and 90 years old&#xD;
&#xD;
          -  The MMSE score is between 16-28&#xD;
&#xD;
          -  The participant does not wear a hearing aid&#xD;
&#xD;
          -  The participant is a native Danish speaker&#xD;
&#xD;
          -  The participant has at least attended school for 7 years&#xD;
&#xD;
          -  The participants' hearing and vision is sufficient to participate in&#xD;
             neuropsychological tests&#xD;
&#xD;
          -  The participants' general condition of health allows that the participant can&#xD;
             cooperate with the trial&#xD;
&#xD;
          -  The participant does not suffer from psychiatric diseases (except mild depressive&#xD;
             symptoms or mild depression) or neurological diseases that affect the brain other than&#xD;
             Lewy body dementia&#xD;
&#xD;
          -  The treatment with anti-dementia medication or SSRI drugs have been given in stable&#xD;
             dose for at least 3 months up to the inclusion and the doctor including the&#xD;
             participant estimates that treatment will not change within the next 6 months&#xD;
&#xD;
          -  No overuse of alcohol or intake of illegal drugs within the last 2 years&#xD;
&#xD;
          -  The participant does not have any contraindications for MRI or MRI contrast&#xD;
&#xD;
          -  The participant is living with another person, who is willing to take part in the&#xD;
             trial, and who is together with the person long enough to observe the behavior (if any&#xD;
             epileptic activity should arise)&#xD;
&#xD;
        Exclusion Criteria (Lewy body dementia):&#xD;
&#xD;
          -  Diagnosis of epilepsy prior to the diagnosis of Lewy body dementia was made&#xD;
&#xD;
          -  Other focal pathology in the hippocampus for example hippocampal sclerosis&#xD;
&#xD;
          -  The person living with the participant is not able to participate (e.g. due to a&#xD;
             serious disease or disability) in the clinical visits or able to register behavior&#xD;
             suspected of epilepsy&#xD;
&#xD;
          -  The participant is living in a nursing home&#xD;
&#xD;
          -  The participant is treated with antiepileptic medication, tricyclic antidepressants or&#xD;
             antipsychotics&#xD;
&#xD;
          -  Daily or nearly daily intake of medication known to have an anticholinergic or an&#xD;
             adrenergic effect, which is suspected to affect the cognitive abilities or the EEG&#xD;
&#xD;
          -  Large brain infarctions or more than 4 lacunar infarcts&#xD;
&#xD;
          -  The participants is suffering from uncontrollable movements of the face as for example&#xD;
             oral dyskinesia&#xD;
&#xD;
        Inclusion Criteria (Healthy controls):&#xD;
&#xD;
          -  Normal cognition as evaluated at the clinical examination&#xD;
&#xD;
          -  The participant is a native Danish speaker&#xD;
&#xD;
          -  The participant has at least attended school for 7 years&#xD;
&#xD;
          -  The participants' hearing and vision is sufficient to participate in&#xD;
             neuropsychological tests&#xD;
&#xD;
          -  The participants' general condition of health allows that the participant can&#xD;
             cooperate with the trial&#xD;
&#xD;
          -  The participant does not suffer from psychiatric diseases (except mild depressive&#xD;
             symptoms or mild depression) or neurological diseases that affect the brain&#xD;
&#xD;
          -  The participant does not have any contraindications for MRI or MRI contrast&#xD;
&#xD;
        Exclusion Criteria (Healthy controls):&#xD;
&#xD;
          -  The participants is suffering from uncontrollable movements of the face as for example&#xD;
             oral dyskinesia&#xD;
&#xD;
          -  The participant is suffering from epilepsy or receives anti-epileptic medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunhild Waldemar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Dementia Research Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian S Musaeus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Dementia Research Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Troels W Kjær, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zealand University Hospital - Roskilde</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristian S Frederiksen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Dementia Research Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gunhild Waldemar, MD</last_name>
    <phone>+4535452580</phone>
    <email>gunhild.waldemar.01@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christian S Musaeus, MD</last_name>
    <phone>+4535456911</phone>
    <email>christian.sandoee.musaeus@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gunhild Waldemar</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen OE</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian S Musaeus</last_name>
      <phone>+45 35456911</phone>
      <email>christian.sandoee.musaeus@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Troels Wesenberg Kjær</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian S Musaeus</last_name>
      <phone>+45 35456911</phone>
      <email>christian.sandoee.musaeus@regionh.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 28, 2019</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 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>Dementia</mesh_term>
    <mesh_term>Lewy Body Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT04436341/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04436341
org study id: H-17035751
nct id: NCT04436341
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the current study, the investigators will examine the extent of subclinical epileptic
      activity in patients with Alzheimer's disease and patients with Lewy body dementia as
      compared to healthy elderly controls. The participants will wear a new device called
      "ear-EEG", which makes it possible to record EEG for longer periods of time while at home.
      Furthermore, the investigators want to investigate whether there is an association between
      subclinical epileptic activity and the cerebral blood flow as measured with functional MRI.
observational model: Cohort
time perspective: Prospective
measure: Feasibility study: Investigate whether patients with Alzheimer's disease are able wear ear-EEG for longer than 24 hours during a 48 hours period
time frame: 8 months
description: If it is possible for patients with Alzheimer's disease to wear ear-EEG for at least 24 hours including 5 hours of sleep during a 48 hours period
measure: Epileptic activity in patients with Alzheimer's disease and Lewy body dementia as compared to healthy elderly controls
time frame: 2 years
description: Compare the prevalence and type of paroxysmal activity as measured with the ear-EEG in patients with Alzheimer's disease and Lewy body dementia as compared to healthy elderly controls
measure: The correlation between cerebral blood flow and paroxysmal acitivity
time frame: 2 years
description: Compare the amount of paroxysmal activity as measured with ear-EEG and the cerebral blood flow (rCBF) as measured with arterial spin labeling fMRI in patients with Alzheimer's disease and Lewy body dementia
arm group label: Patients with Alzheimer's disease
description: No treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples
arm group label: Patients with Lewy body dementia
description: No treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples
arm group label: Healthy controls
description: No treatment interventions. Investigations: physical examination, ear-EEG cranial MR, cognitive tests, blood samples
A total of 13 mL of blood will be collected from each participant. Afterwards, the blood will
      be centrifuged and the serum, plasma and the white blood cells will be extracted. These
      samples will be stored in the Danish Dementia Biobank.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gunhild Waldemar, MD
role: Principal Investigator
affiliation: Danish Dementia Research Centre
last name: Christian S Musaeus, MD
role: Principal Investigator
affiliation: Danish Dementia Research Centre
last name: Troels W Kjær, MD
role: Principal Investigator
affiliation: Zealand University Hospital - Roskilde
last name: Kristian S Frederiksen, MD
role: Principal Investigator
affiliation: Danish Dementia Research Centre
last name: Gunhild Waldemar, MD
phone: +4535452580
email: gunhild.waldemar.01@regionh.dk
last name: Christian S Musaeus, MD
phone: +4535456911
email: christian.sandoee.musaeus@regionh.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Lewy Body Disease
sharing ipd: Undecided
provided document: 