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/NCT05995418</url>
    </required_header>
    <id_info>
      <org_study_id>2023132</org_study_id>
      <nct_id>NCT05995418</nct_id>
    </id_info>
    <brief_title>Study on the Health Economic Burden of Alzheimer's Disease in China</brief_title>
    <official_title>Monetary Costs of Alzheimer's Disease in China: Protocol for a Cluster-randomized Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xuanwu Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xuanwu Hospital, Beijing</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a multi-center and cross-sectional study. Using standardized case report forms,&#xD;
        we randomly selected suitable patients from the cognitive centers of provincial&#xD;
        administrative units in Chinese mainland to conduct a questionnaire survey, so as to obtain&#xD;
        relevant information about their economic burden.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Under the policy background of building a national cognitive center, this study collected and&#xD;
        evaluated the socio-demographic characteristics, geographical location, regional&#xD;
        socio-economic development level, family support, medical resources, related behaviors,&#xD;
        nursing environment, patients' health behaviors, current medical history, past history, drug&#xD;
        use, family history and clinical diagnosis of Alzheimer's patients in inland provinces and&#xD;
        cities of China, and made statistics on the related information of patients' health&#xD;
        economics. To form a comprehensive assessment of the health economic burden of Alzheimer's&#xD;
        disease in China, the primary objectives of the study are as follows:&#xD;
  &#xD;
          1. Comprehensively assess the health economic burden of Alzheimer's disease, including&#xD;
             medical and non-medical costs.&#xD;
  &#xD;
          2. Explore the economic burden of Alzheimer's disease in different stages, including mild&#xD;
             cognitive impairment stage, mild to moderate Alzheimer's disease stage and severe&#xD;
             Alzheimer's disease stage.&#xD;
  &#xD;
          3. To explore the health economic burden of the comorbidity of Alzheimer's disease and&#xD;
             other chronic diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">April 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Direct medical expenses</measure>
      <time_frame>baseline</time_frame>
      <description>Direct medical expenses refer to the expenses incurred by patients and/or their families for medical and health services related to Alzheimer's disease</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Direct non-medical expenses</measure>
      <time_frame>baseline</time_frame>
      <description>The direct non-medical costs of Alzheimer's disease include care costs, home facilities and repair costs, health care products costs and related expenses incurred during medical treatment. The cost of care includes the salary of caregivers, the expenses of external caregivers, and the travel expenses of caregivers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>overhead expenses</measure>
      <time_frame>baseline</time_frame>
      <description>Indirect costs include the economic loss caused by patients' inability to work, the decrease in the income of informal caregivers, the treatment expenses of caregivers' psychological diseases and the medical expenses incurred by patients with Alzheimer's disease or caregivers due to accidental injuries.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">9510</enrollment>
    <condition>Alzheimer Disease</condition>
    <arm_group>
      <arm_group_label>amnestic mild cognitive impairment(aMCI）</arm_group_label>
      <description>aMCI diagnostic criteria of National Institute of Aging and National Association of Alzheimer's Disease (NIA-AA).&#xD;
  The ClinicalDementiaRating scale (CDR) is 0.5.&#xD;
  Mini-MentalStateExamination (MMSE): MMSE≥17 for those with 0 years of education, ≥20 for those with less than 7 years, and ≥24 for those with more than 7 years.&#xD;
  Memory impairment is prominent, and it may also be accompanied by functional impairment of other cognitive domains.&#xD;
  The onset is insidious and the progress is slow.&#xD;
  Not up to the level of dementia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mild to moderate AD</arm_group_label>
      <description>Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>severe AD</arm_group_label>
      <description>Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>There was no intervention as this was an observational study.</intervention_name>
      <description>There was no intervention as this was an observational study.</description>
      <arm_group_label>amnestic mild cognitive impairment(aMCI）</arm_group_label>
      <arm_group_label>mild to moderate AD</arm_group_label>
      <arm_group_label>severe AD</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The research center samples 192 cognitive centers selected by the National Health and&#xD;
          Wellness Commission's Capacity Building and Continuing Education for Cognitive Impairment&#xD;
          Diseases Project in 2022.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Criteria for selection of centers The study center sample relied on the 192 cognitive&#xD;
               centers selected for the 2022 National Health and Health Commission Capacity Building&#xD;
               and Continuing Education for Cognitive Impairment Disease Specialty Capacity Building&#xD;
               Program.&#xD;
  &#xD;
               The study covered all 31 provincial administrative units in mainland China, divided&#xD;
               according to east, center, and west:&#xD;
  &#xD;
               East: Hebei, Beijing, Tianjin, Shandong, Jiangsu, Shanghai, Zhejiang, Fujian,&#xD;
               Guangdong, Hainan, Heilongjiang, Jilin, and Liaoning; Central: Henan, Hubei, Hunan,&#xD;
               Anhui, Jiangxi, Shanxi; West: Chongqing, Sichuan, Yunnan, Guizhou, Tibet, Shaanxi,&#xD;
               Gansu, Qinghai, Xinjiang, Ningxia, Inner Mongolia, Guangxi.&#xD;
  &#xD;
            2. amnestic mild cognitive impairment (aMCI) inclusion criteria (all of the following&#xD;
               conditions must be met at the same time) and exclusion criteria:&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Compliance with Peterson's aMCI diagnostic criteria National Institute on Aging and&#xD;
               Alzheimer's Disease Association (NIA-AA) aMCI diagnostic criteria in 2004 [7].&#xD;
  &#xD;
            2. Clinical Dementia Rating (CDR) of 0.5.&#xD;
  &#xD;
            3. Mini-Mental State Examination (MMSE): ≥17 points on MMSE for those with 0 years of&#xD;
               education, ≥20 points for those with less than 7 years, and ≥24 points for those with&#xD;
               greater than or equal to 7 years.&#xD;
  &#xD;
            4. Memory loss is prominent and may also be accompanied by impairment of other cognitive&#xD;
               domains.&#xD;
  &#xD;
            5. Insidious onset and slow progression.&#xD;
  &#xD;
            6. Not reaching the level of dementia. 3. Alzheimer's disease inclusion criteria (must&#xD;
               meet all of the following conditions at the same time) and exclusion criteria:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Meets the core clinical criteria for probable AD dementia in the 2011 NIA-AA Revised&#xD;
               Diagnostic Criteria for AD. [7]&#xD;
  &#xD;
            2. Can be categorized as having mild, moderate, or severe Alzheimer's disease.&#xD;
  &#xD;
                 1. Mild: progressive cognitive impairment affecting multiple domains and&#xD;
                    psychobehavioral deficits; significant impact on daily life, primarily impairing&#xD;
                    instrumental activities, no longer fully independent, occasionally requiring&#xD;
                    assistance; or a CDR score of 1.0&#xD;
  &#xD;
                 2. Moderate: progressive cognitive impairment and psychobehavioral changes;&#xD;
                    extensive impact on daily life, partial impairment of basic functioning,&#xD;
                    inability to live independently, frequent need for assistance; or CDR 2.0 score&#xD;
  &#xD;
                 3. Severe: progressive cognitive impairment and psychobehavioral changes, may not be&#xD;
                    able to conduct clinical interviews; severe impact on daily life, impairment of&#xD;
                    basic activities including self-care, total dependence on help; or CDR 3.0 points&#xD;
  &#xD;
            3. CDR greater than 0.5 points.&#xD;
  &#xD;
            4. MMSE: &lt;17 points for those with 0 years of education, &lt;20 points for those with less&#xD;
               than 7 years, and &lt;24 points for those with greater than or equal to 7 years.&#xD;
  &#xD;
            5. Subject has good audiovisual and speech functions or can complete a neuropsychological&#xD;
               examination with correction.&#xD;
  &#xD;
            6. The subject and the informant can complete relevant examinations and follow-up visits.&#xD;
  &#xD;
            7. The subject or his/her authorized delegate signs the informed consent form. 4.&#xD;
               Inclusion/exclusion criteria for Alzheimer's disease multiple chronic co-morbidities&#xD;
               (aMCI) need to be met in addition to meeting the aMCI inclusion and exclusion criteria&#xD;
               or Alzheimer's disease inclusion and exclusion criteria:&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Age not less than 60 years&#xD;
  &#xD;
            2. Normal or corrected vision and hearing&#xD;
  &#xD;
            3. able to provide informed consent signed by him/herself or a legal guardian&#xD;
  &#xD;
            4. Newly diagnosed or previously diagnosed with a co-morbid condition other than aMCI or&#xD;
               Alzheimer's disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          2. amnestic mild cognitive impairment (aMCI) exclusion criteria: (excluded if any of the&#xD;
          following conditions are met):&#xD;
  &#xD;
            1. Those with a history of stroke with focal neurologic signs and an imaging presentation&#xD;
               consistent with cerebral small vessel disease manifestations (Fazekas score ≥ 2).&#xD;
  &#xD;
            2. Presence of mental and neurodevelopmental delays.&#xD;
  &#xD;
            3. Presence of other conditions known to cause cognitive impairment.&#xD;
  &#xD;
            4. Presence of a disease that prevents cooperation in completing the cognitive&#xD;
               examination.&#xD;
  &#xD;
            5. Refusal to sign the informed consent form at baseline. 3. Alzheimer's Disease&#xD;
               Exclusion Criteria: (Excluded if any of the following criteria are met):&#xD;
  &#xD;
          1) Presence of mental and neurodevelopmental delays. 2) Disease that prevents cooperation&#xD;
          in completing the cognitive examination. 3) Refusal to sign the informed consent form at&#xD;
          baseline. 4. Inclusion/exclusion criteria for Alzheimer's disease multiple chronic&#xD;
          co-morbidities (aMCI)&#xD;
  &#xD;
          Required on top of meeting aMCI inclusion and exclusion criteria or Alzheimer's disease&#xD;
          inclusion and exclusion criteria:&#xD;
  &#xD;
          Exclusion Criteria (excluded if any of the following conditions are met):&#xD;
  &#xD;
            1. Poor compliance or mental and neurodevelopmental delays.&#xD;
  &#xD;
            2. Illness that prevents the completion of the cognitive examination.&#xD;
  &#xD;
            3. Refusal to sign an informed consent form at baseline.&#xD;
  &#xD;
            4. Severe circulatory, respiratory, urinary, gastrointestinal, hematopoietic diseases&#xD;
               (e.g., unstable angina, uncontrolled asthma, active gastric bleeding, etc.) and&#xD;
               cancer.&#xD;
  &#xD;
            5. No reliably informed person.&#xD;
  &#xD;
            6. Patient has a history of alcohol or drug abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Xuanwu Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <zip>100053</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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>
    </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/NCT05995418
  org study id: 2023132
  nct id: NCT05995418
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multi-center and cross-sectional study. Using standardized case report forms,
        we randomly selected suitable patients from the cognitive centers of provincial
        administrative units in Chinese mainland to conduct a questionnaire survey, so as to obtain
        relevant information about their economic burden.
  Under the policy background of building a national cognitive center, this study collected and
        evaluated the socio-demographic characteristics, geographical location, regional
        socio-economic development level, family support, medical resources, related behaviors,
        nursing environment, patients' health behaviors, current medical history, past history, drug
        use, family history and clinical diagnosis of Alzheimer's patients in inland provinces and
        cities of China, and made statistics on the related information of patients' health
        economics. To form a comprehensive assessment of the health economic burden of Alzheimer's
        disease in China, the primary objectives of the study are as follows:
  
          1. Comprehensively assess the health economic burden of Alzheimer's disease, including
             medical and non-medical costs.
  
          2. Explore the economic burden of Alzheimer's disease in different stages, including mild
             cognitive impairment stage, mild to moderate Alzheimer's disease stage and severe
             Alzheimer's disease stage.
  
          3. To explore the health economic burden of the comorbidity of Alzheimer's disease and
             other chronic diseases.
  observational model: Cohort
  time perspective: Retrospective
  measure: Direct medical expenses
  time frame: baseline
  description: Direct medical expenses refer to the expenses incurred by patients and/or their families for medical and health services related to Alzheimer's disease
  measure: Direct non-medical expenses
  time frame: baseline
  description: The direct non-medical costs of Alzheimer's disease include care costs, home facilities and repair costs, health care products costs and related expenses incurred during medical treatment. The cost of care includes the salary of caregivers, the expenses of external caregivers, and the travel expenses of caregivers
  measure: overhead expenses
  time frame: baseline
  description: Indirect costs include the economic loss caused by patients' inability to work, the decrease in the income of informal caregivers, the treatment expenses of caregivers' psychological diseases and the medical expenses incurred by patients with Alzheimer's disease or caregivers due to accidental injuries.
  arm group label: amnestic mild cognitive impairment(aMCI）
  description: aMCI diagnostic criteria of National Institute of Aging and National Association of Alzheimer's Disease (NIA-AA).
  The ClinicalDementiaRating scale (CDR) is 0.5.
  Mini-MentalStateExamination (MMSE): MMSE≥17 for those with 0 years of education, ≥20 for those with less than 7 years, and ≥24 for those with more than 7 years.
  Memory impairment is prominent, and it may also be accompanied by functional impairment of other cognitive domains.
  The onset is insidious and the progress is slow.
  Not up to the level of dementia
  arm group label: mild to moderate AD
  description: Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.
  arm group label: severe AD
  description: Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.
  intervention type: Other
  intervention name: There was no intervention as this was an observational study.
  description: There was no intervention as this was an observational study.
  arm group label: amnestic mild cognitive impairment(aMCI）
  arm group label: mild to moderate AD
  arm group label: severe AD
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  sharing ipd: Undecided