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/NCT05977712</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230740</org_study_id>
      <secondary_id>2023-A01469-36</secondary_id>
      <nct_id>NCT05977712</nct_id>
    </id_info>
    <brief_title>Circadian Rhythm and Other Factors in Memory Clinic Patients</brief_title>
    <acronym>CIRCAME</acronym>
    <official_title>Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fondation Rothschild Paris</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The CIRCAME study is a bicenter study of patients from 2 memory clinics in Paris. The main&#xD;
        objective is to identify circadian rhythm components and other individual risk factors&#xD;
        (sociodemographic, behavioral, and health related factors) associated with the diagnosis of&#xD;
        subtypes (AD, Lewy bodies, vascular, frontotemporal dementia) and stages (cognitively&#xD;
        healthy, mild cognitive impairment, clinical dementia) of dementia, independent of known risk&#xD;
        factors (sociodemographic and genetic) and assess the relevance of use of these factors in&#xD;
        primary care for screen of dementia including subtypes and stages. A secondary objective is&#xD;
        to determine factors associated with progression of the disease, in terms of cognitive&#xD;
        decline and limitations in activities of daily living, as well as progression to dementia&#xD;
        among cognitively healthy controls and patients with mild cognitive impairment, up to 15&#xD;
        years after the inclusion period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The diagnosis of Alzheimer's disease and other related dementias is mainly based on&#xD;
        assessment of cognitive, behavioral and neuropsychological symptoms, functional limitations&#xD;
        and imaging data/CSF biomarkers in some cases. These measures are primarily used in&#xD;
        specialized clinics leading to a potential large number of dementia cases not being&#xD;
        diagnosed. With population ageing, the number of people living with dementia is increasing&#xD;
        and there is an urgent need for cost-effective, scalable tool for early, accurate screening&#xD;
        of dementia cases, including both AD and other types of dementia, in primary care.&#xD;
        Furthermore, the factors associated with the progression of the different types of dementia&#xD;
        are still poorly understood, limiting the prospects for intervention to improve the quality&#xD;
        of life of patients and their caregivers and to slow the progression of the disease.&#xD;
  &#xD;
        This project aims to identify circadian rhythm components and other individual risk factors&#xD;
        that could be used in primary care for dementia diagnosis (including its subtypes: AD, Lewy&#xD;
        bodies, vascular, frontotemporal dementia) and stages (cognitively healthy, mild cognitive&#xD;
        impairment, clinical dementia). A secondary objective is to determine factors associated with&#xD;
        progression of the disease, in terms of cognitive decline and limitations in activities of&#xD;
        daily living, as well as progression to dementia among cognitively healthy controls and&#xD;
        patients with mild cognitive impairment.&#xD;
  &#xD;
        This will be achieved using data from 1500 patients from 2 memory clinics in Paris from who&#xD;
        data on sociodemographic, behavioral, and health related factors (such as reported sleep&#xD;
        disturbance, plasma biomarkers, retina measures (in a subsample, CIRCAME-EYE)) will be&#xD;
        measured at inclusion interview. Baseline examination will also include a wrist-mounted&#xD;
        device for a measure of circadian rhythm and its related behaviors (physical activity and&#xD;
        sleep), for which disruptions are thought to characterize dementia subtypes and stages.&#xD;
        Information on dementia diagnosis and stages will come from memory clinic routine visits at&#xD;
        the time of the inclusion; they will include subtypes (AD, Lewy bodies, vascular,&#xD;
        frontotemporal dementia), cognitive stages (cognitively healthy, mild cognitive impairment,&#xD;
        clinical dementia) and AD stages based on CSF biomarkers and clinical measures. Information&#xD;
        on progression of the disease (change in cognitive function using the mini-mental status&#xD;
        examination, change in limitations in activity of daily living) and incidence of dementia,&#xD;
        institutionalization and mortality will be retrieved from patients' routine visits at memory&#xD;
        clinics up to 15 years after the inclusion period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2041</completion_date>
    <primary_completion_date type="Anticipated">December 2026</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>Dementia subtypes and stages</measure>
      <time_frame>At inclusion (2024-2025), in 2026 and every 3 years up to 2041</time_frame>
      <description>Dementia subtypes and stages will be defined on routine visits at the memory center and categorised as: Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia), as having MCI (differentiating AD form of MCI and others), or being cognitively healthy.&#xD;
  This outcome will be examined cross-sectionally first (at inclusion) and, among those with MCI and healthy controls, prospectively over time (up to 15 years after the inclusion period).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alzheimer's disease stages</measure>
      <time_frame>At inclusion (2024-2025), in 2026 and every 3 years up to 2041</time_frame>
      <description>AD stages will be based on CSF Aβ peptide level (Aβ42/40 ratio) to assess the A+ criterion, p-Tau 181 to assess the T+ criterion, and clinical examination to assess the CogFI+ criterion (cognitive impairment and/or neurobehavioural symptoms with functional impact on daily life).&#xD;
  This analysis will be among those with CSF biomarkers measured as part of their routine visit at the memory clinics.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fluid based biomarkers of dementia</measure>
      <time_frame>At inclusion</time_frame>
      <description>Association of the different exposure variables with plasma and csf biomarkers of dementia will be examined.&#xD;
  Plasma biomarkers include 1) Amyloid β 42/40 ratio, a marker of AD pathology, although probably less robust than the CSF Aβ 42/40 ratio; 2) phosphorylated tau (p-tau) for detection of early AD-related tauopathy and disease staging; 3) neurofilament light (NfL), a marker of neurodegeneration in all neurodegenerative diseases, and 4) glial fibrillary acidic protein (GFAP), a marker of astrocytosis, found as early as in pre-amyloid AD disease stages.&#xD;
  CSF biomarkers include Aβ42 and Aβ40 peptides, total and phosphorylated tau proteins (when done in routine care).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive function</measure>
      <time_frame>At inclusion (2024-2025), and change between inclusion and 2026 and every 3 years up to 2041</time_frame>
      <description>Cognitive tests include the mini-mental status examination test and the MemScreen test. They will be evaluated at inclusion and during routine visit at the memory clinics. Association with scores at inclusion and changes between inclusion and several time points will be examined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Limitations in activity of daily living (ADL) and instrumental activity of daily living (IADL)</measure>
      <time_frame>At inclusion (2024-2025), and change between inclusion and 2026 and every 3 years up to 2041</time_frame>
      <description>Limitations in ADL (dressing, walking, bathing, eating, continence, using toilet) and IADL (cooking, shopping for grocery, telephone calls, taking medication, using transports, managing money).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Institutionalization, hospitalization and death</measure>
      <time_frame>Incidence between inclusion and 2026 and every 3 years up to 2041</time_frame>
      <description>Information will come from memory clinics and electronic health records.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Dementia</condition>
    <arm_group>
      <arm_group_label>CIRCAME</arm_group_label>
      <description>This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CIRCAME-EYE ancilliary study</arm_group_label>
      <description>Patients from CIRCAME seen at the Fernand-Widal hospital who will also undergo an eye examination (CIRCAME-EYE, N estimated = 1100, a sub-group of CIRCAME)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>The questionnaire includes information on socio-demographics (age, sex, education, occupation, marital status), behavioural (smoking, alcohol consumption, social functioning), and health-related factors (morbidities, treatment, sleep disturbance, eye diseases, frailty, falls).</description>
      <arm_group_label>CIRCAME</arm_group_label>
      <arm_group_label>CIRCAME-EYE ancilliary study</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical examination</intervention_name>
      <description>This includes earing test, cognitive tests (mini-mental status examination, MemScreen), body mass index, waist circumference, blood pressure and blood tests (biomarkers of Alzheimer's disease, neurodegeneration, and other dementias).</description>
      <arm_group_label>CIRCAME</arm_group_label>
      <arm_group_label>CIRCAME-EYE ancilliary study</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Accelerometer port</intervention_name>
      <description>Participants will be wearing an accelerometer for 9 days.</description>
      <arm_group_label>CIRCAME</arm_group_label>
      <arm_group_label>CIRCAME-EYE ancilliary study</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Eye examination</intervention_name>
      <description>Eye fundus photo, OCT and OCT-A exams</description>
      <arm_group_label>CIRCAME-EYE ancilliary study</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and&#xD;
          Bretonneau).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient of legal age (18 or over)&#xD;
  &#xD;
            -  Signed informed consent form&#xD;
  &#xD;
            -  Patient affiliated to the french social security system&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Skin allergy to plastic&#xD;
  &#xD;
            -  Diagnosis of psychiatric disorder that can explain all cognitive symptoms&#xD;
  &#xD;
            -  Inability to come accompanied for patients with a Mini-Mental State Examination (MMSE)&#xD;
               cognitive score ≤20 or a clinician assessment indicating the need to be accompanied&#xD;
               (e.g. wheelchair use, agitation)&#xD;
  &#xD;
            -  Patient of legal age and subject to a legal protection measure (guardianship,&#xD;
               curatorship)&#xD;
  &#xD;
            -  Participation at the time of inclusion and during the 9-day period of wearing the&#xD;
               accelerometer in interventional research with potential impact on circadian rhythm&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Claire PAQUET, MDPhD</last_name>
      <phone>0140054313</phone>
      <phone_ext>33</phone_ext>
      <email>claire.paquet@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Séverine SABIA, PhD</last_name>
      <phone>0157279046</phone>
      <phone_ext>33</phone_ext>
      <email>severine.sabia@inserm.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre de neurologie Cognitive / CMRR</name>
        <address>
          <city>Paris</city>
          <zip>75010</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Claire PAQUET, MDPhD</last_name>
        <phone>0140054313</phone>
        <phone_ext>33</phone_ext>
        <email>claire.paquet@aphp.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital de Jour Gériatrique et consultation mémoire</name>
        <address>
          <city>Paris</city>
          <zip>75018</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Circadian rhythm</keyword>
    <keyword>Sleep disturbance</keyword>
    <keyword>APOE</keyword>
    <keyword>Retinal measures</keyword>
    <keyword>Dementia subtypes, stages and progression</keyword>
    <keyword>Alzheimer's disease</keyword>
    <keyword>Lewy body dementia</keyword>
    <keyword>Plasma biomarkers</keyword>
    <keyword>Cerebrospinal fluid biomarkers</keyword>
    <keyword>Individual risk factors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05977712
  org study id: APHP230740
  secondary id: 2023-A01469-36
  nct id: NCT05977712
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The CIRCAME study is a bicenter study of patients from 2 memory clinics in Paris. The main
        objective is to identify circadian rhythm components and other individual risk factors
        (sociodemographic, behavioral, and health related factors) associated with the diagnosis of
        subtypes (AD, Lewy bodies, vascular, frontotemporal dementia) and stages (cognitively
        healthy, mild cognitive impairment, clinical dementia) of dementia, independent of known risk
        factors (sociodemographic and genetic) and assess the relevance of use of these factors in
        primary care for screen of dementia including subtypes and stages. A secondary objective is
        to determine factors associated with progression of the disease, in terms of cognitive
        decline and limitations in activities of daily living, as well as progression to dementia
        among cognitively healthy controls and patients with mild cognitive impairment, up to 15
        years after the inclusion period.
  The diagnosis of Alzheimer's disease and other related dementias is mainly based on
        assessment of cognitive, behavioral and neuropsychological symptoms, functional limitations
        and imaging data/CSF biomarkers in some cases. These measures are primarily used in
        specialized clinics leading to a potential large number of dementia cases not being
        diagnosed. With population ageing, the number of people living with dementia is increasing
        and there is an urgent need for cost-effective, scalable tool for early, accurate screening
        of dementia cases, including both AD and other types of dementia, in primary care.
        Furthermore, the factors associated with the progression of the different types of dementia
        are still poorly understood, limiting the prospects for intervention to improve the quality
        of life of patients and their caregivers and to slow the progression of the disease.
  
        This project aims to identify circadian rhythm components and other individual risk factors
        that could be used in primary care for dementia diagnosis (including its subtypes: AD, Lewy
        bodies, vascular, frontotemporal dementia) and stages (cognitively healthy, mild cognitive
        impairment, clinical dementia). A secondary objective is to determine factors associated with
        progression of the disease, in terms of cognitive decline and limitations in activities of
        daily living, as well as progression to dementia among cognitively healthy controls and
        patients with mild cognitive impairment.
  
        This will be achieved using data from 1500 patients from 2 memory clinics in Paris from who
        data on sociodemographic, behavioral, and health related factors (such as reported sleep
        disturbance, plasma biomarkers, retina measures (in a subsample, CIRCAME-EYE)) will be
        measured at inclusion interview. Baseline examination will also include a wrist-mounted
        device for a measure of circadian rhythm and its related behaviors (physical activity and
        sleep), for which disruptions are thought to characterize dementia subtypes and stages.
        Information on dementia diagnosis and stages will come from memory clinic routine visits at
        the time of the inclusion; they will include subtypes (AD, Lewy bodies, vascular,
        frontotemporal dementia), cognitive stages (cognitively healthy, mild cognitive impairment,
        clinical dementia) and AD stages based on CSF biomarkers and clinical measures. Information
        on progression of the disease (change in cognitive function using the mini-mental status
        examination, change in limitations in activity of daily living) and incidence of dementia,
        institutionalization and mortality will be retrieved from patients' routine visits at memory
        clinics up to 15 years after the inclusion period.
  observational model: Cohort
  time perspective: Prospective
  measure: Dementia subtypes and stages
  time frame: At inclusion (2024-2025), in 2026 and every 3 years up to 2041
  description: Dementia subtypes and stages will be defined on routine visits at the memory center and categorised as: Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia), as having MCI (differentiating AD form of MCI and others), or being cognitively healthy.
  This outcome will be examined cross-sectionally first (at inclusion) and, among those with MCI and healthy controls, prospectively over time (up to 15 years after the inclusion period).
  measure: Alzheimer's disease stages
  time frame: At inclusion (2024-2025), in 2026 and every 3 years up to 2041
  description: AD stages will be based on CSF Aβ peptide level (Aβ42/40 ratio) to assess the A+ criterion, p-Tau 181 to assess the T+ criterion, and clinical examination to assess the CogFI+ criterion (cognitive impairment and/or neurobehavioural symptoms with functional impact on daily life).
  This analysis will be among those with CSF biomarkers measured as part of their routine visit at the memory clinics.
  measure: Fluid based biomarkers of dementia
  time frame: At inclusion
  description: Association of the different exposure variables with plasma and csf biomarkers of dementia will be examined.
  Plasma biomarkers include 1) Amyloid β 42/40 ratio, a marker of AD pathology, although probably less robust than the CSF Aβ 42/40 ratio; 2) phosphorylated tau (p-tau) for detection of early AD-related tauopathy and disease staging; 3) neurofilament light (NfL), a marker of neurodegeneration in all neurodegenerative diseases, and 4) glial fibrillary acidic protein (GFAP), a marker of astrocytosis, found as early as in pre-amyloid AD disease stages.
  CSF biomarkers include Aβ42 and Aβ40 peptides, total and phosphorylated tau proteins (when done in routine care).
  measure: Cognitive function
  time frame: At inclusion (2024-2025), and change between inclusion and 2026 and every 3 years up to 2041
  description: Cognitive tests include the mini-mental status examination test and the MemScreen test. They will be evaluated at inclusion and during routine visit at the memory clinics. Association with scores at inclusion and changes between inclusion and several time points will be examined.
  measure: Limitations in activity of daily living (ADL) and instrumental activity of daily living (IADL)
  time frame: At inclusion (2024-2025), and change between inclusion and 2026 and every 3 years up to 2041
  description: Limitations in ADL (dressing, walking, bathing, eating, continence, using toilet) and IADL (cooking, shopping for grocery, telephone calls, taking medication, using transports, managing money).
  measure: Institutionalization, hospitalization and death
  time frame: Incidence between inclusion and 2026 and every 3 years up to 2041
  description: Information will come from memory clinics and electronic health records.
  arm group label: CIRCAME
  description: This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500)
  arm group label: CIRCAME-EYE ancilliary study
  description: Patients from CIRCAME seen at the Fernand-Widal hospital who will also undergo an eye examination (CIRCAME-EYE, N estimated = 1100, a sub-group of CIRCAME)
  intervention type: Other
  intervention name: Questionnaire
  description: The questionnaire includes information on socio-demographics (age, sex, education, occupation, marital status), behavioural (smoking, alcohol consumption, social functioning), and health-related factors (morbidities, treatment, sleep disturbance, eye diseases, frailty, falls).
  arm group label: CIRCAME
  arm group label: CIRCAME-EYE ancilliary study
  intervention type: Other
  intervention name: Clinical examination
  description: This includes earing test, cognitive tests (mini-mental status examination, MemScreen), body mass index, waist circumference, blood pressure and blood tests (biomarkers of Alzheimer's disease, neurodegeneration, and other dementias).
  arm group label: CIRCAME
  arm group label: CIRCAME-EYE ancilliary study
  intervention type: Other
  intervention name: Accelerometer port
  description: Participants will be wearing an accelerometer for 9 days.
  arm group label: CIRCAME
  arm group label: CIRCAME-EYE ancilliary study
  intervention type: Other
  intervention name: Eye examination
  description: Eye fundus photo, OCT and OCT-A exams
  arm group label: CIRCAME-EYE ancilliary study
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Claire PAQUET, MDPhD
  phone: 0140054313
  phone ext: 33
  email: claire.paquet@aphp.fr
  last name: Séverine SABIA, PhD
  phone: 0157279046
  phone ext: 33
  email: severine.sabia@inserm.fr
  facility: 
  contact: 
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Dementia
  sharing ipd: No