<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/NCT02264899</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2012/32</org_study_id>
    <nct_id>NCT02264899</nct_id>
  </id_info>
  <brief_title>MEMENTO-VAScular COmponents of Dementia</brief_title>
  <acronym>VASCOD</acronym>
  <official_title>MEMENTO-VAScular COmponents of Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry for Health and Solidarity, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Multicenter national longitudinal cohort study including at least 800 individuals recruited&#xD;
      from French Research Memory Centers and followed up over 36 months and included in Memento.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alzheimer's disease (AD) is a neurodegenerative disorder thought to be caused by the&#xD;
      accumulation of the peptide amyloid beta and the hyperphosphorylated tau protein in the&#xD;
      brain. There are increasing arguments in favor of an important role of vascular damages in&#xD;
      the development and progression of AD.&#xD;
&#xD;
      The time course of these vascular alterations and how they relate to dementia and AD&#xD;
      pathology remain unclear, as no protocol that allows the development of the diverse vascular&#xD;
      pathology to be scored, and hence to be tracked with ageing, has so far been developed and&#xD;
      widely validated. The aims of this project are to investigate, in a large clinical sample of&#xD;
      patients presenting either isolated cognitive complaints or light to mild cognitive deficits,&#xD;
      how vascular risk factors and vascular alterations (assessed at macro and micro levels)&#xD;
      relate to cerebrovascular disease and cognitive decline.&#xD;
&#xD;
      The primary objective of this ancillary study is to investigate the prospective association&#xD;
      between vascular risk factors, inflammation markers and vascular damages on cognitive decline&#xD;
      and neurodegeneration progression over up to 4 years of follow-up in a sample of individuals&#xD;
      presenting with a spectrum of cognitive profiles ranging from isolated cognitive complaints&#xD;
      to cognitive deficits without dementia.&#xD;
&#xD;
      The secondary objectives are the following&#xD;
&#xD;
        -  To investigate the role of vascular risk factors (diabetes, hypertension,&#xD;
           hypercholesterolemia) and vascular damages on progression to clinical dementia over up&#xD;
           to 4-year follow-up.&#xD;
&#xD;
        -  To study whether the interaction between changes in markers of macrovascular and&#xD;
           microvascular structures on cognitive deficits progression.&#xD;
&#xD;
        -  To study the association between in BP, hypertension, antihypertensive treatments and&#xD;
           vascular damages, progression of cerebrovascular disease seen at MRI and cognitive&#xD;
           decline and dementia risk&#xD;
&#xD;
        -  To assess the temporality of vascular damages burden on neurodegeneration&#xD;
&#xD;
        -  To assess the association between retinal vasculature defect and brain neurovascular&#xD;
           damages&#xD;
&#xD;
        -  To study the link between vascular damages and AD pathology (Cerebro-Spinal Fluid (CSF)&#xD;
           and Positron emission tomography (TEP) amyloid imaging) biomarkers in the subsample of&#xD;
           participants having all measures available&#xD;
&#xD;
        -  To investigate how inflammatory markers mediate the association between vascular damages&#xD;
           and neurodegeneration&#xD;
&#xD;
        -  To assess whether vascular factors and neurodegenerative factors act independently or&#xD;
           synergistically on the course of cognitive decline&#xD;
&#xD;
        -  To assess simultaneously the impact of vascular damages on end organs (brain, eye, and&#xD;
           kidney)&#xD;
&#xD;
        -  To study the correlation between cerebral blood flow, measured by Arterial spin-Labeled&#xD;
           (ASL) MRI and cognitive decline&#xD;
&#xD;
        -  To study whether genetic polymorphisms revealed from genome-wide association studies&#xD;
           (GWAS) of AD of vascular factors could modulate the association between vascular damages&#xD;
           and cognitive decline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 4, 2014</start_date>
  <completion_date type="Actual">October 29, 2021</completion_date>
  <primary_completion_date type="Actual">October 29, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive performances over</measure>
    <time_frame>36 months from baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression to clinical dementia of Alzheimer's type according to standardized criteria</measure>
    <time_frame>36 months from baseline</time_frame>
    <description>standardized criteria : Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) classifications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CSF and blood amyloid biomarkers of AD</measure>
    <time_frame>24 months from baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in brain atrophy and hippocampal volumes</measure>
    <time_frame>24 months from baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds)</measure>
    <time_frame>24 months from baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">332</enrollment>
  <condition>Alzheimer's Disease (AD)</condition>
  <condition>Alzheimer's Disease (AD) Related Disorders</condition>
  <arm_group>
    <arm_group_label>Alzheimer's disease and related disorders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>in Memento-VASCOD</intervention_name>
    <description>Pulse wave velocity assessment&#xD;
Cerebral MRI including Arterial Spin Labeling (ASL) and Magnetic Resonance Angiography (MRA) sequences&#xD;
Ophthalmological exams: Spectral Domain-Optical Coherence Tomography (SD-OCT), colour photographs of the retina, visual acuity and axial lenght measurement&#xD;
Neuropsychological testing and behaviorial and mood scales&#xD;
Urinary albumin excretion measurement</description>
    <arm_group_label>Alzheimer's disease and related disorders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants to MEMENTO-Vascod should be included in MEMENTO.&#xD;
&#xD;
          -  To have signed a specific MEMENTO-Vascod informed consent form, prior to any Vascod&#xD;
             ancillary study related procedures&#xD;
&#xD;
          -  To be aged 50 years old and above&#xD;
&#xD;
          -  To have a Clinical Dementia Rating scale &lt;0.5 and to be not demented;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are under guardianship&#xD;
&#xD;
          -  Live in skilled nursing facility&#xD;
&#xD;
          -  Are Pregnant or breast feeding women&#xD;
&#xD;
          -  Meet brain MRI exclusion criteria (Same criteria as in Memento main protocol)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Genevieve CHENE, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIC-EC1401 - ISPED - CHU de Bodeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geneviève CHENE, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>CIC-EC1401 - ISPED - CHU de Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carole DUFOUIL, Director</last_name>
    <role>Study Director</role>
    <affiliation>CIC-EC1401 - ISPED - CHU de Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU d'Amiens</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HM</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hôpital BROCA</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hôpital LARIBOISIERE</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's disease</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <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>
  <!-- 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/NCT02264899
org study id: CHUBX 2012/32
nct id: NCT02264899
lead sponsor: 
collaborator: 
has dmc: No
A Multicenter national longitudinal cohort study including at least 800 individuals recruited
      from French Research Memory Centers and followed up over 36 months and included in Memento.
Alzheimer's disease (AD) is a neurodegenerative disorder thought to be caused by the
      accumulation of the peptide amyloid beta and the hyperphosphorylated tau protein in the
      brain. There are increasing arguments in favor of an important role of vascular damages in
      the development and progression of AD.

      The time course of these vascular alterations and how they relate to dementia and AD
      pathology remain unclear, as no protocol that allows the development of the diverse vascular
      pathology to be scored, and hence to be tracked with ageing, has so far been developed and
      widely validated. The aims of this project are to investigate, in a large clinical sample of
      patients presenting either isolated cognitive complaints or light to mild cognitive deficits,
      how vascular risk factors and vascular alterations (assessed at macro and micro levels)
      relate to cerebrovascular disease and cognitive decline.

      The primary objective of this ancillary study is to investigate the prospective association
      between vascular risk factors, inflammation markers and vascular damages on cognitive decline
      and neurodegeneration progression over up to 4 years of follow-up in a sample of individuals
      presenting with a spectrum of cognitive profiles ranging from isolated cognitive complaints
      to cognitive deficits without dementia.

      The secondary objectives are the following

        -  To investigate the role of vascular risk factors (diabetes, hypertension,
           hypercholesterolemia) and vascular damages on progression to clinical dementia over up
           to 4-year follow-up.

        -  To study whether the interaction between changes in markers of macrovascular and
           microvascular structures on cognitive deficits progression.

        -  To study the association between in BP, hypertension, antihypertensive treatments and
           vascular damages, progression of cerebrovascular disease seen at MRI and cognitive
           decline and dementia risk

        -  To assess the temporality of vascular damages burden on neurodegeneration

        -  To assess the association between retinal vasculature defect and brain neurovascular
           damages

        -  To study the link between vascular damages and AD pathology (Cerebro-Spinal Fluid (CSF)
           and Positron emission tomography (TEP) amyloid imaging) biomarkers in the subsample of
           participants having all measures available

        -  To investigate how inflammatory markers mediate the association between vascular damages
           and neurodegeneration

        -  To assess whether vascular factors and neurodegenerative factors act independently or
           synergistically on the course of cognitive decline

        -  To assess simultaneously the impact of vascular damages on end organs (brain, eye, and
           kidney)

        -  To study the correlation between cerebral blood flow, measured by Arterial spin-Labeled
           (ASL) MRI and cognitive decline

        -  To study whether genetic polymorphisms revealed from genome-wide association studies
           (GWAS) of AD of vascular factors could modulate the association between vascular damages
           and cognitive decline
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in cognitive performances over
time frame: 36 months from baseline
measure: Progression to clinical dementia of Alzheimer's type according to standardized criteria
time frame: 36 months from baseline
description: standardized criteria : Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) classifications
measure: Change in CSF and blood amyloid biomarkers of AD
time frame: 24 months from baseline
measure: Change in brain atrophy and hippocampal volumes
time frame: 24 months from baseline
measure: Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds)
time frame: 24 months from baseline
arm group label: Alzheimer's disease and related disorders
arm group type: Experimental
intervention type: Other
intervention name: in Memento-VASCOD
description: Pulse wave velocity assessment
Cerebral MRI including Arterial Spin Labeling (ASL) and Magnetic Resonance Angiography (MRA) sequences
Ophthalmological exams: Spectral Domain-Optical Coherence Tomography (SD-OCT), colour photographs of the retina, visual acuity and axial lenght measurement
Neuropsychological testing and behaviorial and mood scales
Urinary albumin excretion measurement
arm group label: Alzheimer's disease and related disorders
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Genevieve CHENE, Prof
role: Principal Investigator
affiliation: CIC-EC1401 - ISPED - CHU de Bodeaux
last name: Geneviève CHENE, Prof
role: Study Chair
affiliation: CIC-EC1401 - ISPED - CHU de Bordeaux
last name: Carole DUFOUIL, Director
role: Study Director
affiliation: CIC-EC1401 - ISPED - CHU de Bordeaux
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia