<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/NCT02973971</url>
  </required_header>
  <id_info>
    <org_study_id>ST0055</org_study_id>
    <nct_id>NCT02973971</nct_id>
  </id_info>
  <brief_title>ADDIA Chronobiological Study</brief_title>
  <official_title>Pilot Study on Patients With Mild to Moderate Form of Alzheimer's Disease and Healthy Volunteers: Characterization of Intra-subject Variability and Chronobiological Variations of ADDIA Biomarkers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amoneta Diagnostics SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amoneta Diagnostics SAS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present single center clinical chronobiological study on 24 subjects (12 patients with&#xD;
      mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing&#xD;
      the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using&#xD;
      proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a&#xD;
      kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be&#xD;
      analyzed on samples taken at different time points of the day, including under fasting and&#xD;
      non-fasting conditions and at two periods: day 1 and day 14.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 29, 2018</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>Blood cell biomarker level</measure>
    <time_frame>Two weeks</time_frame>
    <description>To characterize the targeted blood cell biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker expression levels over two periods (day 1, day 15).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Circulating biomarker level</measure>
    <time_frame>two weeks</time_frame>
    <description>To characterize the circulating biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Alzheimer patients</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  12 patients with mild to moderate form of Alzheimer's disease 55 to 85 years-old.&#xD;
&#xD;
          -  12 healthy volunteers (HV), 55 to 85 years-old.&#xD;
&#xD;
          -  Total expected completed subjects: 24.&#xD;
&#xD;
          -  Stratification by gender: 6 males and 6 females, age-matched healthy subjects and 6&#xD;
             males and 6 females, age-matched Alzheimer patients.&#xD;
&#xD;
          -  Mean age similar in both groups&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Alzheimer patient group:&#xD;
&#xD;
          -  Signed Informed Consent.&#xD;
&#xD;
          -  Male or female subject, between 55 and 85 years inclusive.&#xD;
&#xD;
          -  Specific clinical phenotype of AD: Presence of an early and significant episodic&#xD;
             memory impairment (isolated or associated with other cognitive or behavioural changes&#xD;
             that are suggestive of a dementia syndrome) that includes the following:&#xD;
&#xD;
               -  Gradual and progressive change in memory function reported by patient or&#xD;
                  informant over more than 6 months.&#xD;
&#xD;
               -  Objective evidence of an amnesic syndrome of hippocampal type, based on&#xD;
                  significantly impaired performance on an episodic memory test with established&#xD;
                  specificity for mild to moderate AD.&#xD;
&#xD;
          -  Cognitive tests including MMSE score 12 ≤ MMSE ≤ 25 for mild to moderate AD (measured&#xD;
             in the last 3 months), b) Scores of other tests routinely practiced at the hospital&#xD;
             for measurement of memory and cognition shall be compatible with mild to moderate AD.&#xD;
&#xD;
          -  Neuroimaging compatible with a diagnosis of mild to moderate AD.&#xD;
&#xD;
          -  Cerebrospinal fluid (CSF) biomarkers showing at least 2 positive levels out of the 3&#xD;
             biomarkers: CSF Aβ1-42 and tau (Phosphorylated-Tau and/or Total-Tau). CSF collection&#xD;
             and data being only retrospective.&#xD;
&#xD;
        Inclusion Criteria for healthy controls:&#xD;
&#xD;
          -  Signed Informed Consent.&#xD;
&#xD;
          -  Male or female subject, between 55 and 85 years inclusive.&#xD;
&#xD;
          -  Normal clinical and cognitive scores as measured using standard neuropsychological&#xD;
             tests.&#xD;
&#xD;
          -  Normal scores in other neuropsychological tests routinely practiced at the hospital&#xD;
             for measurement of memory and cognition.&#xD;
&#xD;
          -  No abnormal neuroimaging findings in at least structural MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any subject who did not sign the informed consent form.&#xD;
&#xD;
          -  Any chronic neurodegenerative disease (vascular dementia, Parkinson's disease,&#xD;
             Creutzfeldt Jacob, Huntington's disease, etc.), acute neurodegenerative disease&#xD;
             (stroke), history or presence of clinically relevant psychiatric history&#xD;
             (schizophrenia, psychosis), some chronic inflammatory diseases that impact blood cells&#xD;
             (e.g. anemia of inflammation and chronic disease) and some cancers (that impact blood&#xD;
             cells: e.g. leukemia), major sensory deficits that could interfere with cognitive&#xD;
             assessment (visual and auditory), epilepsy.&#xD;
&#xD;
          -  Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice&#xD;
             a month).&#xD;
&#xD;
          -  Blood donation, any volume, within 2 months before inclusion.&#xD;
&#xD;
          -  Neutropenia (Neutrophils &lt; 1500/mm3).&#xD;
&#xD;
          -  Thrombocytopenia (platelets: &lt; 100,000/mm3, rule out EDTA-induced&#xD;
             pseudothrombocytopenia).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Blanc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Strasbourg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine Mutter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <state>Alsace</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood cell biomarkers, peripheral circulating biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT02973971
org study id: ST0055
nct id: NCT02973971
lead sponsor: 
has dmc: Yes
The present single center clinical chronobiological study on 24 subjects (12 patients with
      mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing
      the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using
      proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a
      kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be
      analyzed on samples taken at different time points of the day, including under fasting and
      non-fasting conditions and at two periods: day 1 and day 14.
observational model: Cohort
time perspective: Prospective
measure: Blood cell biomarker level
time frame: Two weeks
description: To characterize the targeted blood cell biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker expression levels over two periods (day 1, day 15).
measure: Circulating biomarker level
time frame: two weeks
description: To characterize the circulating biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker
arm group label: Healthy subjects
arm group label: Alzheimer patients
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frédéric Blanc, MD
role: Principal Investigator
affiliation: Hôpitaux Strasbourg
last name: Catherine Mutter, MD
role: Principal Investigator
affiliation: Hôpitaux Strasbourg
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease