<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/NCT03290040</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2014-032</org_study_id>
    <nct_id>NCT03290040</nct_id>
  </id_info>
  <brief_title>Identification of Predictors for Early Cognitive Decline in Men</brief_title>
  <official_title>Identification of Predictors for Early Cognitive Decline: a Longitudinal Cohort Study in Men Born in 1953</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Healthy Aging, University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <brief_summary>
    <textblock>
      The research program explores how aging influences brain function in test-persons from a&#xD;
      Danish birth cohort of men born in 1953.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research program explores how aging influences brain function in test-persons from a&#xD;
      Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen.&#xD;
&#xD;
      Test-persons are divided among three groups based on performance in cognitive tests at late&#xD;
      midlife compared to young adulthood; 1) Positive expected performance, 2) expected&#xD;
      performance and 3) negative expected performance and sampled from a birth cohort of 11.532&#xD;
      men.&#xD;
&#xD;
      Researchers aim to identify factors earlier in life that affect or predict changes in&#xD;
      cognitive function, specifically of cognitive decline in order to predict healthy vs&#xD;
      unhealthy cognitive aging, including progression to possible dementia. The objective is to be&#xD;
      able to predict cognitive decline in aging.&#xD;
&#xD;
      During the four years of data collection approximately 300-400 participants will be included&#xD;
      and examined.&#xD;
&#xD;
      The examinations include cognitive test including Cambridge Neuropsychological test automated&#xD;
      Battery (CANTAB); sleep, life events and depression questionnaire; blood sample analysis&#xD;
      including functional analyses of mitochondria and gen analyses such as genome scanning, SNP&#xD;
      analysis, ApoE ε-type; structural and functional changes in the brain measured with magnetic&#xD;
      resonance (fMRI) and electroencephalography (EEG) recordings of electrical activity and&#xD;
      visual attention.&#xD;
&#xD;
      The results from these studies will hopefully point to new avenues for intervention in order&#xD;
      to change the course of brain aging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">February 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Gamma band EEG power during evoked potentials correlates to cognitive decline</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Visual and auditory evoked potentials are elicited in the brain using flickering visual stimuli and amplitude-modulated tones, respectively. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alpha band EEG-power during evoked potentials correlates to cognitive decline</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Examination of how visual attention effects cognitive deterioration.</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>The accuracy of reporting shown isoluminant letters of the patient is compared to speed of processing (ms), IQ and short term memory function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clarification of how processing speed (ms), short term memory and visual perceptive threshold effect cognitive capacity.</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Relating brain states to attentional functions by linking visual event-related potentials measured with EEG to specific attentional functions derived from behavioural testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in mitochondrial respiration as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microstructural parameters, derived from diffusion tensor imaging as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between basal ganglia volumes and structure and cognitive functions</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Basal ganglia volumes are based on automatic segmentation procedures. Basal ganglia microstructure and iron content will be estimated using quantitative susceptibility imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between patterns of brain perfusion and patterns of cognitive function</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Brain perfusion will be measured with arterial spin labeling, and the analysis performed using multivariate techniques</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between Subjective sleep quality and patterns of cognitive function</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive functions are based on CANTAB as well as paper and pencil tests. Sleep quality is measured using the self-report questionnaire Pittsburgh Sleep quality Index (PSQI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective sleep measures: Sleep stages as determined by standard international scoring and quantitated measures using - spectral analysis from sleep EEG in relation to cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of demographic, social and health predictors on change in cognitive function from young adulthood to late midlife</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite score (based on CANTAB, paper- and pencil tests)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between daytime sleepiness and patterns of cognitive function</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive functions are based on CANTAB as well as paper and pencil tests. Daytime sleepiness is measured using the Epworh Sleepiness Scale (ESS) questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gamma band EEG power distribution across the scalp during simultaneous auditory and visual stimulation correlates to cognitive decline</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Visual and auditory evoked potentials are elicited in the brain using a paradigm that presents a visual stimulus and an auditory stimulus simultaneously. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of source location of gamma band EEG power of visual evoked potentials correlates to cognitive decline</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The investigators would like to describe how visual attention correlates with the background EEG recorded before the examination.</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Linking functional effects of prestimulus alpha power measured by EEG to perception accuracy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in levels of reactive oxygen species in PBMCs quantified by flow cytometry after application of dedicated fluorophores as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in levels of mitochondrial bioenergetics in PBMCs using the Seahorse XF24 extracellular flux analyser as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of levels of whole cell dNTP levels in PBMCs using polymerase extension assay and by quantification of tritiated nucleotides by scintillation counting as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of mutation frequency of mitochondrial DNA using deep sequencing as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of mtDNA copy number by qPCR as predictor of cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between regional cortical thickness and cognitive parameters</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Cortical thickness will be analysed using FreeSurfer or similar software, and the analysis performed using multivariate techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between regional cortical surface and cognitive parameters</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Cortical surface will be analysed using FreeSurfer or similar software, and the analysis performed using multivariate techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between macrostructural parameters and candidate genes</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Macrostructural parameters will be derived from segmentation of T1-weighted images. The statistical analysis will consider macrostructural parameters as a possible mediator of common genetic variants upon cognition. Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between microstructural parameters and candidate genes</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Microstructural parameters will be derived from diffusion tensor imaging. The statistical analysis will consider microstructural parameters as a possible mediator of common genetic variants upon cognition. Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between macrostructural parameters and cognition</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Macrostructural parameters will be derived from segmentation of T1-weighted images. Cognitive composite scores are based on CANTAB as well as paper and pencil test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between microstructural parameters and cognition</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Microstructural parameters will be derived from diffusion tensor imaging. Cognitive composite scores are based on CANTAB as well as paper and pencil test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between cognition and candidate genes</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite scores are based on CANTAB as well as paper and pencil test.Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between sleep stages and microstructural parameters.</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Sleep stages will be determined by standard international scoring and quantitated measures using spectral analysis from sleep EEG. Microstructures will be measured with MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between sleep stages and regional volumes.</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Sleep stages will be determined by standard international scoring and quantitated measures using spectral analysis from sleep EEG. Regional volumes will be measured with MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic activity as measured by electrocardiography determined from the polysomnography during wakefulness and sleep in relation to cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of REM Sleep muscle activity (REM sleep without atonia (RSWA), REM Behavior disorder(RBD)) in relation to cognitive impairment</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive correlates of cognitive change</measure>
    <time_frame>Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years</time_frame>
    <description>Cognitive composite score (based on CANTAB, paper- and pencil tests)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Healthy Test Persons</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples with DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Danish birth cohort of 11.532 men born in 1953 in the Metropolitan area of Copenhagen.&#xD;
&#xD;
        Only men who have participated in the Copenhagen Aging and Midlife Biobank project are&#xD;
        considered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have participated in the Metropolit study and in the Copenhagen Aging&#xD;
             and Midlife Biobank project&#xD;
&#xD;
          -  Participants who have been informed about the project and who have signed the informed&#xD;
             consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons who have been asked to participate in the past and have rejected&#xD;
&#xD;
          -  Reduced ability to understand project information&#xD;
&#xD;
          -  Reduced ability to complete the examinations&#xD;
&#xD;
          -  Abuse of alcohol, psychedelic drugs or habit-forming drugs&#xD;
&#xD;
          -  Certain neurological disorders&#xD;
&#xD;
          -  Certain neurological, mental or psychiatric diagnoses&#xD;
&#xD;
          -  Certain depressive diseases&#xD;
&#xD;
          -  Former traumatic brain injury&#xD;
&#xD;
          -  Contraindication for MR scanning&#xD;
&#xD;
          -  Pathological MR result&#xD;
&#xD;
          -  Persons that do not like to be informed about a possible pathological result&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin J Lauritzen, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin J Lauritzen, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup, Neuronal Signalling Lab, Center for Neuroscience, University of Copenhagen and Center for Healthy aging, University of Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lene Rask, PhD</last_name>
    <phone>+45 38634009</phone>
    <email>lene.rask.01@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin J Lauritzen, Prof</last_name>
    <phone>+45 38 63 39 33</phone>
    <email>martin.johannes.lauritzen@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept. of Clinical Neurophysiology, Department of Clinical Biochemistry and Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet - Glostrup</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lene Rask, PhD</last_name>
      <phone>+45 38634009</phone>
      <email>lene.rask.01@regionh.dk</email>
    </contact>
    <contact_backup>
      <last_name>Martin J Lauritzen, Prof</last_name>
      <phone>+45 38 63 39 33</phone>
      <email>martin.johannes.lauritzen@regionh.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 18, 2015</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>March 7, 2019</last_update_submitted>
  <last_update_submitted_qc>March 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Martin Lauritzen</investigator_full_name>
    <investigator_title>Professor, Consulting</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03290040
org study id: H-1-2014-032
nct id: NCT03290040
lead sponsor: 
collaborator: 
collaborator: 
The research program explores how aging influences brain function in test-persons from a
      Danish birth cohort of men born in 1953.
The research program explores how aging influences brain function in test-persons from a
      Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen.

      Test-persons are divided among three groups based on performance in cognitive tests at late
      midlife compared to young adulthood; 1) Positive expected performance, 2) expected
      performance and 3) negative expected performance and sampled from a birth cohort of 11.532
      men.

      Researchers aim to identify factors earlier in life that affect or predict changes in
      cognitive function, specifically of cognitive decline in order to predict healthy vs
      unhealthy cognitive aging, including progression to possible dementia. The objective is to be
      able to predict cognitive decline in aging.

      During the four years of data collection approximately 300-400 participants will be included
      and examined.

      The examinations include cognitive test including Cambridge Neuropsychological test automated
      Battery (CANTAB); sleep, life events and depression questionnaire; blood sample analysis
      including functional analyses of mitochondria and gen analyses such as genome scanning, SNP
      analysis, ApoE ε-type; structural and functional changes in the brain measured with magnetic
      resonance (fMRI) and electroencephalography (EEG) recordings of electrical activity and
      visual attention.

      The results from these studies will hopefully point to new avenues for intervention in order
      to change the course of brain aging.
observational model: Cohort
time perspective: Prospective
measure: Gamma band EEG power during evoked potentials correlates to cognitive decline
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Visual and auditory evoked potentials are elicited in the brain using flickering visual stimuli and amplitude-modulated tones, respectively. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
measure: Alpha band EEG-power during evoked potentials correlates to cognitive decline
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
measure: Examination of how visual attention effects cognitive deterioration.
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: The accuracy of reporting shown isoluminant letters of the patient is compared to speed of processing (ms), IQ and short term memory function.
measure: Clarification of how processing speed (ms), short term memory and visual perceptive threshold effect cognitive capacity.
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Relating brain states to attentional functions by linking visual event-related potentials measured with EEG to specific attentional functions derived from behavioural testing
measure: Changes in mitochondrial respiration as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Microstructural parameters, derived from diffusion tensor imaging as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Correlation between basal ganglia volumes and structure and cognitive functions
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Basal ganglia volumes are based on automatic segmentation procedures. Basal ganglia microstructure and iron content will be estimated using quantitative susceptibility imaging
measure: Correlation between patterns of brain perfusion and patterns of cognitive function
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Brain perfusion will be measured with arterial spin labeling, and the analysis performed using multivariate techniques
measure: Correlation between Subjective sleep quality and patterns of cognitive function
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive functions are based on CANTAB as well as paper and pencil tests. Sleep quality is measured using the self-report questionnaire Pittsburgh Sleep quality Index (PSQI).
measure: Objective sleep measures: Sleep stages as determined by standard international scoring and quantitated measures using - spectral analysis from sleep EEG in relation to cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Effects of demographic, social and health predictors on change in cognitive function from young adulthood to late midlife
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite score (based on CANTAB, paper- and pencil tests)
measure: Correlation between daytime sleepiness and patterns of cognitive function
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive functions are based on CANTAB as well as paper and pencil tests. Daytime sleepiness is measured using the Epworh Sleepiness Scale (ESS) questionnaire.
measure: Gamma band EEG power distribution across the scalp during simultaneous auditory and visual stimulation correlates to cognitive decline
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Visual and auditory evoked potentials are elicited in the brain using a paradigm that presents a visual stimulus and an auditory stimulus simultaneously. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject
measure: Change of source location of gamma band EEG power of visual evoked potentials correlates to cognitive decline
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
measure: The investigators would like to describe how visual attention correlates with the background EEG recorded before the examination.
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Linking functional effects of prestimulus alpha power measured by EEG to perception accuracy
measure: Change in levels of reactive oxygen species in PBMCs quantified by flow cytometry after application of dedicated fluorophores as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Change in levels of mitochondrial bioenergetics in PBMCs using the Seahorse XF24 extracellular flux analyser as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Change of levels of whole cell dNTP levels in PBMCs using polymerase extension assay and by quantification of tritiated nucleotides by scintillation counting as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Change of mutation frequency of mitochondrial DNA using deep sequencing as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Change of mtDNA copy number by qPCR as predictor of cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Correlation between regional cortical thickness and cognitive parameters
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Cortical thickness will be analysed using FreeSurfer or similar software, and the analysis performed using multivariate techniques
measure: Correlation between regional cortical surface and cognitive parameters
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Cortical surface will be analysed using FreeSurfer or similar software, and the analysis performed using multivariate techniques
measure: Correlation between macrostructural parameters and candidate genes
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Macrostructural parameters will be derived from segmentation of T1-weighted images. The statistical analysis will consider macrostructural parameters as a possible mediator of common genetic variants upon cognition. Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.
measure: Correlation between microstructural parameters and candidate genes
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Microstructural parameters will be derived from diffusion tensor imaging. The statistical analysis will consider microstructural parameters as a possible mediator of common genetic variants upon cognition. Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.
measure: Correlation between macrostructural parameters and cognition
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Macrostructural parameters will be derived from segmentation of T1-weighted images. Cognitive composite scores are based on CANTAB as well as paper and pencil test.
measure: Correlation between microstructural parameters and cognition
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Microstructural parameters will be derived from diffusion tensor imaging. Cognitive composite scores are based on CANTAB as well as paper and pencil test.
measure: Correlation between cognition and candidate genes
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite scores are based on CANTAB as well as paper and pencil test.Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.
measure: Correlation between sleep stages and microstructural parameters.
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Sleep stages will be determined by standard international scoring and quantitated measures using spectral analysis from sleep EEG. Microstructures will be measured with MRI.
measure: Correlation between sleep stages and regional volumes.
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Sleep stages will be determined by standard international scoring and quantitated measures using spectral analysis from sleep EEG. Regional volumes will be measured with MRI.
measure: Autonomic activity as measured by electrocardiography determined from the polysomnography during wakefulness and sleep in relation to cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Presence of REM Sleep muscle activity (REM sleep without atonia (RSWA), REM Behavior disorder(RBD)) in relation to cognitive impairment
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
measure: Cognitive correlates of cognitive change
time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
description: Cognitive composite score (based on CANTAB, paper- and pencil tests)
Blood samples with DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Martin J Lauritzen, Prof
role: Principal Investigator
affiliation: Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup
last name: Martin J Lauritzen, Prof
role: Principal Investigator
affiliation: Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup, Neuronal Signalling Lab, Center for Neuroscience, University of Copenhagen and Center for Healthy aging, University of Copenhagen
last name: Lene Rask, PhD
phone: +45 38634009
email: lene.rask.01@regionh.dk
last name: Martin J Lauritzen, Prof
phone: +45 38 63 39 33
email: martin.johannes.lauritzen@regionh.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Martin Lauritzen
investigator title: Professor, Consulting
mesh term: Cognitive Dysfunction