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/NCT06010511</url>
    </required_header>
    <id_info>
      <org_study_id>WHIMAS</org_study_id>
      <nct_id>NCT06010511</nct_id>
    </id_info>
    <brief_title>WHIte MAtter Hyperintensity Shape and Glymphatics</brief_title>
    <acronym>WHIMAS</acronym>
    <official_title>White Matter Hyperintensity Shape and Glymphatics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leiden University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Alzheimer Nederland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Leiden University Medical Center</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 a society with increased life expectancy, the economic, social and personal burden of&#xD;
        dementia increases. Dementia is often caused by a combination of neurovascular and&#xD;
        neurodegenerative diseases. Impaired brain clearance is suggested to be closely related to&#xD;
        dementia development, as waste products (e.g. amyloid beta) accumulate in the brain, leading&#xD;
        to neurodegeneration. Cerebral small vessel disease (SVD) is the most common neurovascular&#xD;
        disease that even contributes to about 45% of dementia pathophysiology in patients with a&#xD;
        diagnosis of Alzheimer's dementia. White matter hyperintensities of presumed vascular origin&#xD;
        (WMH) are the key brain MRI manifestation of cerebral SVD. There is evidence that the&#xD;
        currently known and MRI-visible WMH are landmarks of an already progressed stage of the&#xD;
        underlying pathology. The pathophysiology of WMH has been attributed to multiple underlying&#xD;
        mechanisms, such as hypoperfusion, defective cerebrovascular reactivity and blood-brain&#xD;
        barrier dysfunction. Furthermore, different anatomical locations and different types of WMH&#xD;
        are related to different underlying pathological changes. Using ultra-high field 7T MR&#xD;
        imaging techniques WMH lesions can be detected with a higher sensitivity and resolution than&#xD;
        on 3T MRI. The hypothesis is that different pathological mechanisms of cerebral SVD lead to&#xD;
        variations in WMH shape. Moreover, the brain clearance ('glymphatic') system of the brain&#xD;
        appears to be tightly connected to dementia pathology. Thus, novel markers of glymphatic&#xD;
        activity could aid to describe and understand the pathology.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim:&#xD;
  &#xD;
        The overall aim is to study how different pathological mechanisms in cerebral SVD influence&#xD;
        WMH shape.&#xD;
  &#xD;
        Primary objective:&#xD;
  &#xD;
        To study the association of a more complex WMH shape with abnormalities in small vessel&#xD;
        morphology.&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
        To study the association between WMH shape and cognition/other cerebral small vessel disease&#xD;
        markers. To study the association of novel MRI markers of glymphatics with cerebral SVD&#xD;
        markers and cognition.&#xD;
  &#xD;
        Study design: Cross-sectional study that will be conducted at the Leiden University Medical&#xD;
        Center (LUMC). The study contains 3T and 7T MRI scans, as well as neuropsychological&#xD;
        assessments. The data will be analyzed by performing association analysis.&#xD;
  &#xD;
        Study population: Patients of the memory/geriatric clinic of the LUMC that are over 65 years&#xD;
        of age.&#xD;
  &#xD;
        Main study parameter/endpoint: In order to postulate underlying mechanisms related to WMH&#xD;
        shape variations the investigators will study the association between a more complex WMH&#xD;
        shape and structural and functional markers of cerebral SVD (such as lacunes and&#xD;
        microbleeds).&#xD;
  &#xD;
        WMH shape is assessed as follows: Convexity, solidity, concavity index, and fractal dimension&#xD;
        are calculated for periventricular/confluent WMH. A lower convexity and solidity, and higher&#xD;
        concavity index and fractal dimension indicate a more irregular shape of&#xD;
        periventricular/confluent WMH. For deep WMH, fractal dimension and eccentricity are&#xD;
        determined. A higher eccentricity and fractal dimension indicate a more complex shape of deep&#xD;
        WMH.&#xD;
  &#xD;
        Other study parameters: The investigators want to investigate WMH shape parameters and the&#xD;
        association with cognition (mini-mental state exam, clinical dementia rating and cognitive&#xD;
        domain scores). Another endpoint is to investigate if different WMH phenotypes can be&#xD;
        identified (by machine learning models). Moreover, the association between SVD&#xD;
        markers/cognition and novel glymphatics markers (such as size of perivascular spaces, CSF&#xD;
        mobility and 4th ventricle CSF flow dynamics) will be investigated.&#xD;
  &#xD;
        Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
        relatedness: The participants will not directly benefit from the results of the study.&#xD;
        However, their contribution to the study will add important information about the&#xD;
        pathophysiology of the cerebrovascular pathology that contributes to dementia. Therefore, it&#xD;
        is not possible to study the research question in a different population group. The&#xD;
        ultra-high field 7T MRI system is widely used in a research setting and since its first&#xD;
        introduction in the 1990s no serious adverse events have been reported. Important temporary&#xD;
        side-effects are vertigo, nausea and involuntary eye motion due to forces on ion currents in&#xD;
        the semicircular loops. As all MRI scans are performed within a maximum of 60 minutes and&#xD;
        without any contrast agents, the participant burden is seen as a non-substantial burden.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 18, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>WMH shape</measure>
      <time_frame>at study visit during inclusion up to 3 years</time_frame>
      <description>The investigators will use an in-house developed analysis pipeline to calculate WMH shape on 3T and 7T brain MRI scans. Associations between WMH shape and other SVD markers and cognition will be investigated with linear and logistic regression (at least corrected for age and sex).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Brain clearance</measure>
      <time_frame>at study visit during inclusion up to 3 years</time_frame>
      <description>Measured on brain MRI as a marker of glymphatic activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perivascular space volume</measure>
      <time_frame>at study visit during inclusion up to 3 years</time_frame>
      <description>This marker will be measured on brain MRI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WMH subtypes</measure>
      <time_frame>at study visit during inclusion up to 3 years</time_frame>
      <description>Based on WMH parameters the investigators will study if subtypes of WMH can be identified.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cerebral Small Vessel Diseases</condition>
    <condition>Dementia, Mixed</condition>
    <condition>Dementia, Vascular</condition>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Cognitive Impairment</condition>
    <condition>Cognitive Decline</condition>
    <arm_group>
      <arm_group_label>Memory clinic patients</arm_group_label>
      <description>We will prospectively include patients with memory complaints and/or vascular brain abnormalities (n=50; over 65 years of age) from the memory clinic (or geriatric clinic) at one of their first visits, prior to any diagnosis, at the Leiden University Medical Center.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>3T MRI scan</intervention_name>
      <description>Conventional (3T) brain MRI scans will be used to determine global and functional markers of cerebral SVD, like WMH volume and presence of lacunes, microbleeds and superficial siderosis (3D T1, 3D FLAIR, SWI, DWI), hemodynamics (arterial spin labelling &amp; flow territory mapping) and white matter structural integrity (diffusion tensor imaging (DTI)). Furthermore, we want to measure structural integrity with a novel MR fingerprinting sequence and an inhomogeneous magnetization transfer (ihMT) MRI scan. We also want to apply a fMRI scan technique to measure CSF fluctuations in the 4th ventricle as a measure of brain glymphatics. Also the flow-territory mapping sequence is a non-standard sequence. Heart rate and respiratory signal will be measured during the scans (3T and 7T MRI) with standard vendor-supplied equipment.</description>
      <arm_group_label>Memory clinic patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>7T MRI scan</intervention_name>
      <description>Ultra-high field (7T) brain MRI scans will be used to determine WMH shape and other markers of cerebral SVD in or surrounding the WMH, like local enlarged perivascular spaces, (cortical) microinfarcts and microbleeds (T1, T2, FLAIR and T2*) and vascular pulsatility (phase contrast MRI). Moreover, a recently implemented MRI technique to measure glymphatic flow in perivascular spaces will be used.</description>
      <arm_group_label>Memory clinic patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Neuropsychological assessment</intervention_name>
      <description>Mini-mental state examination&#xD;
  Clock drawing&#xD;
  15-Word Verbal Learning Test, immediate and delayed&#xD;
  Visual Association Test&#xD;
  Stroop Color Word Test, 40 item version&#xD;
  Trail Making Test A&amp;B&#xD;
  Letter Digit Substitution Test&#xD;
  Animal fluency test&#xD;
  Hospital anxiety and depression scale&#xD;
  Informant Questionnaire on Cognitive Decline in the Elderly</description>
      <arm_group_label>Memory clinic patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>General baseline data</intervention_name>
      <description>Baseline data, such as age, sex, psychiatric comorbidity and medication lists will be extracted from the patient files.&#xD;
  Age (Year of birth); Years of education; BMI (height &amp; weight); Sex; Verhage scale (education); Smoking status; Blood values; Sleep habits; Waste-hip ratio; Blood pressure; Current/general cardiovascular health; Psychiatric comorbidity; medical history related to cardiovascular health.</description>
      <arm_group_label>Memory clinic patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We will prospectively include patients with memory complaints and/or vascular brain&#xD;
          abnormalities (n=50; over 65 years of age) from the memory clinic at one of their first&#xD;
          visits, prior to any diagnosis, at the Leiden University Medical Center. If not enough&#xD;
          eligible patients are available from the memory clinic, we will include participants from&#xD;
          the geriatric clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admitted to the memory or the geriatric clinic of the LUMC&#xD;
  &#xD;
            -  From 65 years of age&#xD;
  &#xD;
            -  Eligible for MRI&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Claustrophobia&#xD;
  &#xD;
            -  Contraindications for MRI such as metal implants and pacemaker&#xD;
  &#xD;
            -  Use of benzodiazepines&#xD;
  &#xD;
            -  Initiated treatment with antidepressants less than 6 weeks prior to inclusion&#xD;
  &#xD;
            -  Not being able to provide written informed consent (assessed by the treating&#xD;
               physician)&#xD;
  &#xD;
            -  Individuals that have been declared mentally incapacitated&#xD;
  &#xD;
            -  Other severe neurological disease besides dementia related&#xD;
  &#xD;
            -  Cognitive impairment due to known other neurological disease&#xD;
  &#xD;
            -  Previous brain surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeroen de Bresser, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Leiden University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jasmin Annica Keller, MSc</last_name>
      <phone>0031715265411</phone>
      <email>j.a.keller@lumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeroen de Bresser, MD, PhD</last_name>
      <phone>0031715262052</phone>
      <email>J.H.J.M.de_Bresser@lumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Leiden University Medical Center</name>
        <address>
          <city>Leiden</city>
          <zip>2333ZA</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jasmin Annica Keller, MSc</last_name>
        <phone>0031715265411</phone>
        <email>j.a.keller@lumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Jeroen de Bresser, MD, PhD</last_name>
        <phone>0031715262052</phone>
        <email>J.H.J.M.de_Bresser@lumc.nl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <citation>Bos D, Wolters FJ, Darweesh SKL, Vernooij MW, de Wolf F, Ikram MA, Hofman A. Cerebral small vessel disease and the risk of dementia: A systematic review and meta-analysis of population-based evidence. Alzheimers Dement. 2018 Nov;14(11):1482-1492. doi: 10.1016/j.jalz.2018.04.007. Epub 2018 May 21.</citation>
      <PMID>29792871</PMID>
    </reference>
    <reference>
      <citation>Ghaznawi R, Geerlings MI, Jaarsma-Coes M, Hendrikse J, de Bresser J; UCC-Smart Study Group. Association of White Matter Hyperintensity Markers on MRI and Long-term Risk of Mortality and Ischemic Stroke: The SMART-MR Study. Neurology. 2021 Apr 27;96(17):e2172-e2183. doi: 10.1212/WNL.0000000000011827. Epub 2021 Mar 16.</citation>
      <PMID>33727406</PMID>
    </reference>
    <reference>
      <citation>Ghaznawi R, Geerlings MI, Jaarsma-Coes MG, Zwartbol MH, Kuijf HJ, van der Graaf Y, Witkamp TD, Hendrikse J, de Bresser J. The association between lacunes and white matter hyperintensity features on MRI: The SMART-MR study. J Cereb Blood Flow Metab. 2019 Dec;39(12):2486-2496. doi: 10.1177/0271678X18800463. Epub 2018 Sep 11.</citation>
      <PMID>30204039</PMID>
    </reference>
    <reference>
      <citation>Keller JA, Sigurdsson S, Klaassen K, Hirschler L, van Buchem MA, Launer LJ, van Osch MJP, Gudnason V, de Bresser J. White matter hyperintensity shape is associated with long-term dementia risk. Alzheimers Dement. 2023 Jun 12. doi: 10.1002/alz.13345. Online ahead of print.</citation>
      <PMID>37303267</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>Jeroen de Bresser</investigator_full_name>
      <investigator_title>Principal Investigator; MD; PhD</investigator_title>
    </responsible_party>
    <keyword>dementia</keyword>
    <keyword>cerebral small vessel disease</keyword>
    <keyword>White matter hyperintensities</keyword>
    <keyword>cognitive impairment</keyword>
    <keyword>cognitive decline</keyword>
    <keyword>Glymphatics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Cerebral Small Vessel Diseases</mesh_term>
      <mesh_term>Dementia, Vascular</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06010511
  org study id: WHIMAS
  nct id: NCT06010511
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In a society with increased life expectancy, the economic, social and personal burden of
        dementia increases. Dementia is often caused by a combination of neurovascular and
        neurodegenerative diseases. Impaired brain clearance is suggested to be closely related to
        dementia development, as waste products (e.g. amyloid beta) accumulate in the brain, leading
        to neurodegeneration. Cerebral small vessel disease (SVD) is the most common neurovascular
        disease that even contributes to about 45% of dementia pathophysiology in patients with a
        diagnosis of Alzheimer's dementia. White matter hyperintensities of presumed vascular origin
        (WMH) are the key brain MRI manifestation of cerebral SVD. There is evidence that the
        currently known and MRI-visible WMH are landmarks of an already progressed stage of the
        underlying pathology. The pathophysiology of WMH has been attributed to multiple underlying
        mechanisms, such as hypoperfusion, defective cerebrovascular reactivity and blood-brain
        barrier dysfunction. Furthermore, different anatomical locations and different types of WMH
        are related to different underlying pathological changes. Using ultra-high field 7T MR
        imaging techniques WMH lesions can be detected with a higher sensitivity and resolution than
        on 3T MRI. The hypothesis is that different pathological mechanisms of cerebral SVD lead to
        variations in WMH shape. Moreover, the brain clearance ('glymphatic') system of the brain
        appears to be tightly connected to dementia pathology. Thus, novel markers of glymphatic
        activity could aid to describe and understand the pathology.
  Aim:
  
        The overall aim is to study how different pathological mechanisms in cerebral SVD influence
        WMH shape.
  
        Primary objective:
  
        To study the association of a more complex WMH shape with abnormalities in small vessel
        morphology.
  
        Secondary objectives:
  
        To study the association between WMH shape and cognition/other cerebral small vessel disease
        markers. To study the association of novel MRI markers of glymphatics with cerebral SVD
        markers and cognition.
  
        Study design: Cross-sectional study that will be conducted at the Leiden University Medical
        Center (LUMC). The study contains 3T and 7T MRI scans, as well as neuropsychological
        assessments. The data will be analyzed by performing association analysis.
  
        Study population: Patients of the memory/geriatric clinic of the LUMC that are over 65 years
        of age.
  
        Main study parameter/endpoint: In order to postulate underlying mechanisms related to WMH
        shape variations the investigators will study the association between a more complex WMH
        shape and structural and functional markers of cerebral SVD (such as lacunes and
        microbleeds).
  
        WMH shape is assessed as follows: Convexity, solidity, concavity index, and fractal dimension
        are calculated for periventricular/confluent WMH. A lower convexity and solidity, and higher
        concavity index and fractal dimension indicate a more irregular shape of
        periventricular/confluent WMH. For deep WMH, fractal dimension and eccentricity are
        determined. A higher eccentricity and fractal dimension indicate a more complex shape of deep
        WMH.
  
        Other study parameters: The investigators want to investigate WMH shape parameters and the
        association with cognition (mini-mental state exam, clinical dementia rating and cognitive
        domain scores). Another endpoint is to investigate if different WMH phenotypes can be
        identified (by machine learning models). Moreover, the association between SVD
        markers/cognition and novel glymphatics markers (such as size of perivascular spaces, CSF
        mobility and 4th ventricle CSF flow dynamics) will be investigated.
  
        Nature and extent of the burden and risks associated with participation, benefit and group
        relatedness: The participants will not directly benefit from the results of the study.
        However, their contribution to the study will add important information about the
        pathophysiology of the cerebrovascular pathology that contributes to dementia. Therefore, it
        is not possible to study the research question in a different population group. The
        ultra-high field 7T MRI system is widely used in a research setting and since its first
        introduction in the 1990s no serious adverse events have been reported. Important temporary
        side-effects are vertigo, nausea and involuntary eye motion due to forces on ion currents in
        the semicircular loops. As all MRI scans are performed within a maximum of 60 minutes and
        without any contrast agents, the participant burden is seen as a non-substantial burden.
  observational model: Case-Only
  time perspective: Prospective
  measure: WMH shape
  time frame: at study visit during inclusion up to 3 years
  description: The investigators will use an in-house developed analysis pipeline to calculate WMH shape on 3T and 7T brain MRI scans. Associations between WMH shape and other SVD markers and cognition will be investigated with linear and logistic regression (at least corrected for age and sex).
  measure: Brain clearance
  time frame: at study visit during inclusion up to 3 years
  description: Measured on brain MRI as a marker of glymphatic activity.
  measure: Perivascular space volume
  time frame: at study visit during inclusion up to 3 years
  description: This marker will be measured on brain MRI.
  measure: WMH subtypes
  time frame: at study visit during inclusion up to 3 years
  description: Based on WMH parameters the investigators will study if subtypes of WMH can be identified.
  arm group label: Memory clinic patients
  description: We will prospectively include patients with memory complaints and/or vascular brain abnormalities (n=50; over 65 years of age) from the memory clinic (or geriatric clinic) at one of their first visits, prior to any diagnosis, at the Leiden University Medical Center.
  intervention type: Other
  intervention name: 3T MRI scan
  description: Conventional (3T) brain MRI scans will be used to determine global and functional markers of cerebral SVD, like WMH volume and presence of lacunes, microbleeds and superficial siderosis (3D T1, 3D FLAIR, SWI, DWI), hemodynamics (arterial spin labelling & flow territory mapping) and white matter structural integrity (diffusion tensor imaging (DTI)). Furthermore, we want to measure structural integrity with a novel MR fingerprinting sequence and an inhomogeneous magnetization transfer (ihMT) MRI scan. We also want to apply a fMRI scan technique to measure CSF fluctuations in the 4th ventricle as a measure of brain glymphatics. Also the flow-territory mapping sequence is a non-standard sequence. Heart rate and respiratory signal will be measured during the scans (3T and 7T MRI) with standard vendor-supplied equipment.
  arm group label: Memory clinic patients
  intervention type: Other
  intervention name: 7T MRI scan
  description: Ultra-high field (7T) brain MRI scans will be used to determine WMH shape and other markers of cerebral SVD in or surrounding the WMH, like local enlarged perivascular spaces, (cortical) microinfarcts and microbleeds (T1, T2, FLAIR and T2*) and vascular pulsatility (phase contrast MRI). Moreover, a recently implemented MRI technique to measure glymphatic flow in perivascular spaces will be used.
  arm group label: Memory clinic patients
  intervention type: Behavioral
  intervention name: Neuropsychological assessment
  description: Mini-mental state examination
  Clock drawing
  15-Word Verbal Learning Test, immediate and delayed
  Visual Association Test
  Stroop Color Word Test, 40 item version
  Trail Making Test A&B
  Letter Digit Substitution Test
  Animal fluency test
  Hospital anxiety and depression scale
  Informant Questionnaire on Cognitive Decline in the Elderly
  arm group label: Memory clinic patients
  intervention type: Other
  intervention name: General baseline data
  description: Baseline data, such as age, sex, psychiatric comorbidity and medication lists will be extracted from the patient files.
  Age (Year of birth); Years of education; BMI (height & weight); Sex; Verhage scale (education); Smoking status; Blood values; Sleep habits; Waste-hip ratio; Blood pressure; Current/general cardiovascular health; Psychiatric comorbidity; medical history related to cardiovascular health.
  arm group label: Memory clinic patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jeroen de Bresser, MD, PhD
  role: Principal Investigator
  affiliation: Leiden University Medical Center
  last name: Jasmin Annica Keller, MSc
  phone: 0031715265411
  email: j.a.keller@lumc.nl
  last name: Jeroen de Bresser, MD, PhD
  phone: 0031715262052
  email: J.H.J.M.de_Bresser@lumc.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Netherlands
  citation: Bos D, Wolters FJ, Darweesh SKL, Vernooij MW, de Wolf F, Ikram MA, Hofman A. Cerebral small vessel disease and the risk of dementia: A systematic review and meta-analysis of population-based evidence. Alzheimers Dement. 2018 Nov;14(11):1482-1492. doi: 10.1016/j.jalz.2018.04.007. Epub 2018 May 21.
  PMID: 29792871
  citation: Ghaznawi R, Geerlings MI, Jaarsma-Coes M, Hendrikse J, de Bresser J; UCC-Smart Study Group. Association of White Matter Hyperintensity Markers on MRI and Long-term Risk of Mortality and Ischemic Stroke: The SMART-MR Study. Neurology. 2021 Apr 27;96(17):e2172-e2183. doi: 10.1212/WNL.0000000000011827. Epub 2021 Mar 16.
  PMID: 33727406
  citation: Ghaznawi R, Geerlings MI, Jaarsma-Coes MG, Zwartbol MH, Kuijf HJ, van der Graaf Y, Witkamp TD, Hendrikse J, de Bresser J. The association between lacunes and white matter hyperintensity features on MRI: The SMART-MR study. J Cereb Blood Flow Metab. 2019 Dec;39(12):2486-2496. doi: 10.1177/0271678X18800463. Epub 2018 Sep 11.
  PMID: 30204039
  citation: Keller JA, Sigurdsson S, Klaassen K, Hirschler L, van Buchem MA, Launer LJ, van Osch MJP, Gudnason V, de Bresser J. White matter hyperintensity shape is associated with long-term dementia risk. Alzheimers Dement. 2023 Jun 12. doi: 10.1002/alz.13345. Online ahead of print.
  PMID: 37303267
  responsible party type: Principal Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: Jeroen de Bresser
  investigator title: Principal Investigator; MD; PhD
  mesh term: Dementia
  mesh term: Cerebral Small Vessel Diseases
  mesh term: Dementia, Vascular
  mesh term: Cognitive Dysfunction
  sharing ipd: Undecided