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/NCT06025877</url>
    </required_header>
    <id_info>
      <org_study_id>C2N002</org_study_id>
      <nct_id>NCT06025877</nct_id>
    </id_info>
    <brief_title>Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey</brief_title>
    <acronym>QUIP II</acronym>
    <official_title>Quality Improvement PrecivityAD2(TM): A Survey and Clinical Utility Study of the PrecivityAD2 Blood Test in the Evaluation of Cognitive Impairment (QUIP II)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>C2N Diagnostics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>C2N Diagnostics</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>
        There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients&#xD;
        presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in&#xD;
        the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI)&#xD;
        available at&#xD;
        https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-im&#xD;
        pairment. Accessed August 16, 2022). MCI does not substantially interfere with daily&#xD;
        activities, although complex functional tasks may be performed less efficiently (Knopman DS,&#xD;
        Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin&#xD;
        Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI&#xD;
        patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH,&#xD;
        Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular&#xD;
        health study cognition study. Arch Neurol.&#xD;
        2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by&#xD;
        chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury,&#xD;
        often associated with significant interference with the ability to function at work or at&#xD;
        usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a&#xD;
        clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459.&#xD;
        doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a&#xD;
        cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available&#xD;
        at&#xD;
        https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-im&#xD;
        pairment. Accessed August 16, 2022).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Quality Improvement PrecivityAD2(TM) Clinician Survey and Clinical Utility Study (QUIP&#xD;
        II) represents a large-scale initiative for the PrecivityAD2 blood test for use by&#xD;
        neurologists, geriatricians, and geropsychiatrists (memory care specialists) who see patients&#xD;
        aged 55 years and older with signs or symptoms of MCI or dementia.&#xD;
  &#xD;
        C₂N Diagnostics, LLC is a CLIA-certified, CAP-accredited diagnostic testing laboratory based&#xD;
        in St. Louis, MO. Its new test, the PrecivityAD2 blood test, measures plasma amyloid beta&#xD;
        (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to&#xD;
        non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217)&#xD;
        ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely&#xD;
        to have brain amyloid plaques, a pathological hallmark of AD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Change in planned clinical management (Cohort A and B)</measure>
      <time_frame>Day 20</time_frame>
      <description>The association of the test result on medical decision making</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in planned clinical management (Cohort B)</measure>
      <time_frame>Day 0 vs Day 20</time_frame>
      <description>Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)</measure>
      <time_frame>Day 90</time_frame>
      <description>Evaluate the intended use criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relationship between the test result and actual clinical management (Cohort B)</measure>
      <time_frame>Day 90</time_frame>
      <description>Association of the test result on subsequent conducted changes in clinical management and test results when evaluating individuals with MCI or dementia in an ambulatory setting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in planned clinical management compared to conducted clinical management (Cohort B only)</measure>
      <time_frame>Day 20 vs Day 90</time_frame>
      <description>The evaluation of planned versus conducted change in management as a result of receiving the test result</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in probability of AD (Cohort A and B)</measure>
      <time_frame>Day 0 vs Day 20</time_frame>
      <description>Evaluate the probability of an AD Dx pre and post receipt of the test result</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in anti-AD medication use (Cohort A and B)</measure>
      <time_frame>Day 0 vs Day 20</time_frame>
      <description>Evaluate anti-AD medication use pre- and post-receipt of the test result</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in diagnosis (Cohort B)</measure>
      <time_frame>Day 0 vs Day 90</time_frame>
      <description>Evaluate any changes in diagnoses as a result of receiving the AD test result</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between the test result and planned testing (Cohort B)</measure>
      <time_frame>Day 0 vs Day 20 vs Day 90</time_frame>
      <description>Evaluate the association between subsequent test ordering pre and post testing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlations between the net promoter score and ease of use by APS2 result (Cohort B)</measure>
      <time_frame>Day 90</time_frame>
      <description>Focus group questions around net promoter score and ease of use, strengths, and limitations of testing</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Alzheimer Disease</condition>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Dementia</condition>
    <condition>Cognitive Decline</condition>
    <condition>Cognitive Impairment</condition>
    <condition>Memory Impairment</condition>
    <arm_group>
      <arm_group_label>Cohort A</arm_group_label>
      <description>One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B</arm_group_label>
      <description>Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PrecivityAD2(TM) blood test</intervention_name>
      <description>The PrecivityAD2 blood test measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.</description>
      <arm_group_label>Cohort A</arm_group_label>
      <arm_group_label>Cohort B</arm_group_label>
      <other_name>AD2</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include up to 40 memory care specialists who will use the&#xD;
          PrecivityAD2 blood test and complete the respective surveys. Participating clinicians will&#xD;
          be selected based on their ability to meet the acceptance measures from the inclusion and&#xD;
          exclusion criteria. Cohort A will include up to 100 test samples collected for the&#xD;
          PrecivityAD2 blood test. Cohort B will include up to 300 test samples collected for the&#xD;
          PrecivityAD2 blood test.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Physician Inclusion Criteria:&#xD;
  &#xD;
            1. Memory care specialists actively practicing in the United States&#xD;
  &#xD;
            2. Practice serves individuals with MCI or dementia age &gt; 55 years&#xD;
  &#xD;
            3. Average patient volume &gt; 25 visits per week (all patients seen across practice)&#xD;
  &#xD;
            4. Memory care specialist with access to an online electronic survey&#xD;
  &#xD;
          Physician Exclusion Criteria:&#xD;
  &#xD;
          1) Clinicians who practice in New York&#xD;
  &#xD;
          Participant Inclusion Criteria:&#xD;
  &#xD;
            1. Individual with MCI or dementia&#xD;
  &#xD;
            2. Age &gt;= 55 years&#xD;
  &#xD;
          Participant Exclusion Criteria&#xD;
  &#xD;
            1. Individual requiring test related blood draw within the state of New York&#xD;
  &#xD;
            2. Participation does not seem to be in the best interest of the individual, per the&#xD;
               ordering clinician&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mark Monane, MD, MBA, AGSF</last_name>
      <role>Principal Investigator</role>
      <affiliation>C₂N Diagnostics, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leslie M Jacobs, CCRP, PMP</last_name>
      <phone>314-464-0002</phone>
      <email>ljacobs@c2n.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Cognitive Dysfunction</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/NCT06025877
  org study id: C2N002
  nct id: NCT06025877
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients
        presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in
        the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI)
        available at
        https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-im
        pairment. Accessed August 16, 2022). MCI does not substantially interfere with daily
        activities, although complex functional tasks may be performed less efficiently (Knopman DS,
        Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin
        Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI
        patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH,
        Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular
        health study cognition study. Arch Neurol.
        2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by
        chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury,
        often associated with significant interference with the ability to function at work or at
        usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a
        clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459.
        doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a
        cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available
        at
        https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-im
        pairment. Accessed August 16, 2022).
  The Quality Improvement PrecivityAD2(TM) Clinician Survey and Clinical Utility Study (QUIP
        II) represents a large-scale initiative for the PrecivityAD2 blood test for use by
        neurologists, geriatricians, and geropsychiatrists (memory care specialists) who see patients
        aged 55 years and older with signs or symptoms of MCI or dementia.
  
        C₂N Diagnostics, LLC is a CLIA-certified, CAP-accredited diagnostic testing laboratory based
        in St. Louis, MO. Its new test, the PrecivityAD2 blood test, measures plasma amyloid beta
        (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to
        non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217)
        ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely
        to have brain amyloid plaques, a pathological hallmark of AD.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in planned clinical management (Cohort A and B)
  time frame: Day 20
  description: The association of the test result on medical decision making
  measure: Change in planned clinical management (Cohort B)
  time frame: Day 0 vs Day 20
  description: Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result
  measure: Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)
  time frame: Day 90
  description: Evaluate the intended use criteria
  measure: Relationship between the test result and actual clinical management (Cohort B)
  time frame: Day 90
  description: Association of the test result on subsequent conducted changes in clinical management and test results when evaluating individuals with MCI or dementia in an ambulatory setting
  measure: Change in planned clinical management compared to conducted clinical management (Cohort B only)
  time frame: Day 20 vs Day 90
  description: The evaluation of planned versus conducted change in management as a result of receiving the test result
  measure: Change in probability of AD (Cohort A and B)
  time frame: Day 0 vs Day 20
  description: Evaluate the probability of an AD Dx pre and post receipt of the test result
  measure: Change in anti-AD medication use (Cohort A and B)
  time frame: Day 0 vs Day 20
  description: Evaluate anti-AD medication use pre- and post-receipt of the test result
  measure: Change in diagnosis (Cohort B)
  time frame: Day 0 vs Day 90
  description: Evaluate any changes in diagnoses as a result of receiving the AD test result
  measure: Relationship between the test result and planned testing (Cohort B)
  time frame: Day 0 vs Day 20 vs Day 90
  description: Evaluate the association between subsequent test ordering pre and post testing
  measure: Correlations between the net promoter score and ease of use by APS2 result (Cohort B)
  time frame: Day 90
  description: Focus group questions around net promoter score and ease of use, strengths, and limitations of testing
  arm group label: Cohort A
  description: One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result
  arm group label: Cohort B
  description: Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result
  intervention type: Other
  intervention name: PrecivityAD2(TM) blood test
  description: The PrecivityAD2 blood test measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.
  arm group label: Cohort A
  arm group label: Cohort B
  other name: AD2
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  last name: Mark Monane, MD, MBA, AGSF
  role: Principal Investigator
  affiliation: C₂N Diagnostics, LLC
  last name: Leslie M Jacobs, CCRP, PMP
  phone: 314-464-0002
  email: ljacobs@c2n.com
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Cognitive Dysfunction
  sharing ipd: No