xml: <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/NCT05989087</url>
    </required_header>
    <id_info>
      <org_study_id>DokuzEU EEG</org_study_id>
      <nct_id>NCT05989087</nct_id>
    </id_info>
    <brief_title>The Resting-state EEG Gamma Oscillations in Alzheimer's Disease</brief_title>
    <acronym>EEG</acronym>
    <official_title>The Underestimated Utility of Resting-state Gamma Oscillations: Both Increase and Decrease of Gamma Discriminates Early-onset Alzheimer's Disease Patients From Healthy Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Görsev Yener, MD, PhD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dokuz Eylul University</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>
        The literature suggests a strong association between amyloid accumulation and gamma&#xD;
        alterations, emerging gamma activity as a biomarker candidate for Alzheimer's pathology. The&#xD;
        present study aims to investigate resting-state gamma activity changes in Cerebrospinal fluid&#xD;
        (CSF)-proven early-onset Alzheimer's disease (EOAD) patients with a holistic approach that&#xD;
        employs structural and functional brain neuroimaging techniques, and neuropsychological&#xD;
        aspects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This cross-sectional study included 24 drug-naive CSF-proven EOAD patients and age-, sex, and&#xD;
        education-matched healthy controls. All participants underwent a detailed neuropsychological&#xD;
        evaluation, resting-state electroencephalography (EEG) recording, and Magnetic Resonance&#xD;
        Imaging (MRI). Gamma power and coherence were measured in total gamma (30-48 Hz), gamma-1&#xD;
        (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz) frequency bands. Gray matter volumes&#xD;
        were extracted for 54 regions of interest (ROIs) and compared between groups. Discriminant&#xD;
        analysis was performed to determine the classification accuracy of gamma activity for EOAD.&#xD;
        Finally, correlations between CSF, neuropsychological tests, EEG, and MRI measures were&#xD;
        explored.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 7, 2012</start_date>
    <completion_date type="Actual">April 5, 2019</completion_date>
    <primary_completion_date type="Actual">January 2, 2016</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>EEG</measure>
      <time_frame>Day 2</time_frame>
      <description>The resting state EEG recordings were acquired using Easy-Cap comprising 30 Ag/AgCl electrodes placed according to the international 10-20 system. Coherence and maximum peak power of the total gamma (30-48 Hz) and sub-gamma bands [gamma-1 (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz)] were measured for each participant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation Analysis</measure>
      <time_frame>3 months</time_frame>
      <description>Correlations between CSF, neuropsychological tests (NPT), EEG, and MRI measures were investigated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Discriminant Analysis</measure>
      <time_frame>3 months</time_frame>
      <description>The discriminative power of gamma measures (power and coherence) was investigated with discriminant analysis (DA).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MRI</measure>
      <time_frame>Day 1</time_frame>
      <description>Participants underwent structural magnetic resonance imaging on a Philips Achieva 1.5 Tesla scanner. The gray matter volumes were obtained from the 3D-T1 weighted Turbo field echo (TFE) sequence (TR: 9ms, Time to Echo (TE): 4ms, Field-of-view (FOV): 240mm, matrix: 256, slice thickness: 1mm, numbers of signal averages (NSA): 1). The images were segmented into gray matter, white matter, and CSF with the default parameters of the CAT12 segmentation function. Only the gray matter calculations were compared between groups.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">51</enrollment>
    <condition>Alzheimer Disease, Early Onset</condition>
    <arm_group>
      <arm_group_label>Early-onset Alzheimer's disease</arm_group_label>
      <description>Patients were recruited from the outpatient memory clinics of the Department of Neurology, Dokuz Eylül University Hospital. The patient group was diagnosed by an expert neurologist, according to the National Institute on Aging-Alzheimer's Association diagnostic criteria for Alzheimer's disease</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
      <description>Age-and gender-matched healthy volunteers were recruited via advertisements and word-of-mouth.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CSF</intervention_name>
      <description>Early-onset Alzheimer's disease patients underwent routine laboratory tests to obtain CSF samples. Also, all participants underwent structural MRI examinations and neuropsychological tests.</description>
      <arm_group_label>Early-onset Alzheimer's disease</arm_group_label>
      <other_name>MRI</other_name>
      <other_name>Neuropsychological tests</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The present study included a retrospective investigation of EEG and MRI data. The total&#xD;
          sample for the study consisted of 24 early-onset Alzheimer's disease patients and 24&#xD;
          healthy controls.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For all participants: Age &lt; 65&#xD;
  &#xD;
            -  For EOAD patients: Meeting National Institute on Aging-Alzheimer's Association&#xD;
               diagnostic criteria.&#xD;
  &#xD;
            -  For healthy controls: Mini-Mental State Examination (MMSE) &gt;25 Instrumental Activities&#xD;
               of Daily Living Scale (IADL) = 8&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For EOAD patients: MMSE &gt; 24 Geriatric depression scale (GDS) &gt; 14 Having treatment&#xD;
               with antipsychotics and comorbidities that may affect cognitive abilities.&#xD;
  &#xD;
            -  For healthy controls: Having neurological and/or cognitive abnormalities Having a&#xD;
               history of neurological, psychiatric, or systemic disorders, and alcohol/drug abuse.&#xD;
               GDS &gt; 14&#xD;
  &#xD;
            -  For all participants: Having neurological (other than AD) or any other serious disease&#xD;
               (cancer, systemic disease)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>İzmir University of Economics</name>
        <address>
          <city>İzmir</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
      <investigator_full_name>Görsev Yener, MD, PhD</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Alzheimer's disease</keyword>
    <keyword>Gamma activity</keyword>
    <keyword>Resting-state EEG</keyword>
    <keyword>Discriminative power</keyword>
    <keyword>MRI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The data that support the findings of this study are available from the contact person, upon reasonable request.</ipd_description>
    </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>July 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT05989087/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989087
  org study id: DokuzEU EEG
  nct id: NCT05989087
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The literature suggests a strong association between amyloid accumulation and gamma
        alterations, emerging gamma activity as a biomarker candidate for Alzheimer's pathology. The
        present study aims to investigate resting-state gamma activity changes in Cerebrospinal fluid
        (CSF)-proven early-onset Alzheimer's disease (EOAD) patients with a holistic approach that
        employs structural and functional brain neuroimaging techniques, and neuropsychological
        aspects.
  This cross-sectional study included 24 drug-naive CSF-proven EOAD patients and age-, sex, and
        education-matched healthy controls. All participants underwent a detailed neuropsychological
        evaluation, resting-state electroencephalography (EEG) recording, and Magnetic Resonance
        Imaging (MRI). Gamma power and coherence were measured in total gamma (30-48 Hz), gamma-1
        (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz) frequency bands. Gray matter volumes
        were extracted for 54 regions of interest (ROIs) and compared between groups. Discriminant
        analysis was performed to determine the classification accuracy of gamma activity for EOAD.
        Finally, correlations between CSF, neuropsychological tests, EEG, and MRI measures were
        explored.
  observational model: Other
  time perspective: Retrospective
  measure: EEG
  time frame: Day 2
  description: The resting state EEG recordings were acquired using Easy-Cap comprising 30 Ag/AgCl electrodes placed according to the international 10-20 system. Coherence and maximum peak power of the total gamma (30-48 Hz) and sub-gamma bands [gamma-1 (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz)] were measured for each participant.
  measure: Correlation Analysis
  time frame: 3 months
  description: Correlations between CSF, neuropsychological tests (NPT), EEG, and MRI measures were investigated.
  measure: Discriminant Analysis
  time frame: 3 months
  description: The discriminative power of gamma measures (power and coherence) was investigated with discriminant analysis (DA).
  measure: MRI
  time frame: Day 1
  description: Participants underwent structural magnetic resonance imaging on a Philips Achieva 1.5 Tesla scanner. The gray matter volumes were obtained from the 3D-T1 weighted Turbo field echo (TFE) sequence (TR: 9ms, Time to Echo (TE): 4ms, Field-of-view (FOV): 240mm, matrix: 256, slice thickness: 1mm, numbers of signal averages (NSA): 1). The images were segmented into gray matter, white matter, and CSF with the default parameters of the CAT12 segmentation function. Only the gray matter calculations were compared between groups.
  arm group label: Early-onset Alzheimer's disease
  description: Patients were recruited from the outpatient memory clinics of the Department of Neurology, Dokuz Eylül University Hospital. The patient group was diagnosed by an expert neurologist, according to the National Institute on Aging-Alzheimer's Association diagnostic criteria for Alzheimer's disease
  arm group label: Healthy controls
  description: Age-and gender-matched healthy volunteers were recruited via advertisements and word-of-mouth.
  intervention type: Diagnostic Test
  intervention name: CSF
  description: Early-onset Alzheimer's disease patients underwent routine laboratory tests to obtain CSF samples. Also, all participants underwent structural MRI examinations and neuropsychological tests.
  arm group label: Early-onset Alzheimer's disease
  other name: MRI
  other name: Neuropsychological tests
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Dokuz Eylul University
  investigator full name: Görsev Yener, MD, PhD
  investigator title: Clinical Professor
  mesh term: Alzheimer Disease
  sharing ipd: Undecided
  ipd description: The data that support the findings of this study are available from the contact person, upon reasonable request.
  provided document: 