<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/NCT04427436</url>
  </required_header>
  <id_info>
    <org_study_id>MD070</org_study_id>
    <nct_id>NCT04427436</nct_id>
  </id_info>
  <brief_title>Novel Dementia Biomarkers</brief_title>
  <official_title>Investigating the Potential of Novel Dementia Biomarkers - an MRI, fNIRS and EEG Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Center for Neurodegenerative Diseases (DZNE)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Otto-von-Guericke University Magdeburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>German Center for Neurodegenerative Diseases (DZNE)</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 study will investigate structural and functional characteristics of the brain of dementia&#xD;
      patients compared to healthy controls in order to get a better insight into importance of&#xD;
      early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining&#xD;
      biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and&#xD;
      electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments.&#xD;
      Special parameters are being studied that have already been shown to detect changes in the&#xD;
      early stages of Alzheimer's dementia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Locus Coeruleus (LC) Intensity</measure>
    <time_frame>15 minutes</time_frame>
    <description>LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of brain regions</measure>
    <time_frame>30 minutes</time_frame>
    <description>VBM (voxel-based morphometry)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fNIRS-based change in oxyhemoglobin and deoxyhemoglobin</measure>
    <time_frame>1 hour</time_frame>
    <description>In response to each task there is a hemodynamic response, which can be measured by fNIRS. In particular, fNIRS measures changes in blood oxy- and deoxy-hemoglobin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)</measure>
    <time_frame>1 hour</time_frame>
    <description>Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability (HRV)</measure>
    <time_frame>1 hour</time_frame>
    <description>ECG-based variability measures in R-R intervals, both in rest abd during tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on CERAD-Plus</measure>
    <time_frame>30 minutes</time_frame>
    <description>Cognitive performance measure in points, with a higher score meaning better performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Error-rate on Stroop-test</measure>
    <time_frame>10 minutes</time_frame>
    <description>Test of executive functions, higher error-rate means worse performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Error-rate on N-Back-test</measure>
    <time_frame>10 minutes</time_frame>
    <description>Working memory test, higher error-rate means worse performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance on verbal fluency test</measure>
    <time_frame>10 minutes</time_frame>
    <description>Test of verbal fluency, more words spoken means a better score</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Alzheimer Disease, Early Onset</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Mild Cognitive Impairment (clinical determination)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy Elderly</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>No Intervention</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged between 50 and 80 years will be recruited from the memory clinic at the&#xD;
        Department of Neurology of the Otto von Guericke University Clinic, Magdeburg, Germany. The&#xD;
        diagnosis of MCI/AD will be established by experienced neurologists of the memory clinic&#xD;
        according to standardised criteria. Control participants will be matched by education, age&#xD;
        and gender. These will be recruited through advertisement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed MCI patients and matched healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metal in body and tatoos;&#xD;
&#xD;
          -  Other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal&#xD;
             diseases which have been proven to influence the outcome variables&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Colour blindness&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Surgery in the last 6 months&#xD;
&#xD;
          -  Uncorrected vision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>German Center for Neurodegenerative Diseases (DZNE)</investigator_affiliation>
    <investigator_full_name>Notger Müller</investigator_full_name>
    <investigator_title>Professor Dr. Notger Müller</investigator_title>
  </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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04427436
org study id: MD070
nct id: NCT04427436
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will investigate structural and functional characteristics of the brain of dementia
      patients compared to healthy controls in order to get a better insight into importance of
      early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining
      biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and
      electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments.
      Special parameters are being studied that have already been shown to detect changes in the
      early stages of Alzheimer's dementia.
observational model: Cohort
time perspective: Cross-Sectional
measure: Locus Coeruleus (LC) Intensity
time frame: 15 minutes
description: LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))
measure: Volume of brain regions
time frame: 30 minutes
description: VBM (voxel-based morphometry)
measure: fNIRS-based change in oxyhemoglobin and deoxyhemoglobin
time frame: 1 hour
description: In response to each task there is a hemodynamic response, which can be measured by fNIRS. In particular, fNIRS measures changes in blood oxy- and deoxy-hemoglobin.
measure: Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)
time frame: 1 hour
description: Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))
measure: Heart Rate Variability (HRV)
time frame: 1 hour
description: ECG-based variability measures in R-R intervals, both in rest abd during tasks
measure: Score on CERAD-Plus
time frame: 30 minutes
description: Cognitive performance measure in points, with a higher score meaning better performance
measure: Error-rate on Stroop-test
time frame: 10 minutes
description: Test of executive functions, higher error-rate means worse performance
measure: Error-rate on N-Back-test
time frame: 10 minutes
description: Working memory test, higher error-rate means worse performance
measure: Performance on verbal fluency test
time frame: 10 minutes
description: Test of verbal fluency, more words spoken means a better score
arm group label: Patients
description: Mild Cognitive Impairment (clinical determination)
arm group label: Control
description: Healthy Elderly
intervention type: Other
intervention name: No Intervention
description: No Intervention
arm group label: Control
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: German Center for Neurodegenerative Diseases (DZNE)
investigator full name: Notger Müller
investigator title: Professor Dr. Notger Müller
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: Undecided