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/NCT06041789</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00111080</org_study_id>
      <secondary_id>R21AG078982</secondary_id>
      <nct_id>NCT06041789</nct_id>
    </id_info>
    <brief_title>Effect of Acetylcholinesterase Inhibitors on Bone Metabolism</brief_title>
    <official_title>Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have&#xD;
        shown that those taking donepezil have a lower rate of bone fractures, but the reasons for&#xD;
        this are unknown. The purpose of this study is to measure the effect of donepezil treatment&#xD;
        on bone metabolism factors including bone mineral density, bone turnover markers, and bone&#xD;
        quality.&#xD;
  &#xD;
        Participants in this study will have a bone density test and have blood samples collected at&#xD;
        the baseline study visit. Participants will then be randomly assigned to donepezil or&#xD;
        matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at&#xD;
        6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will&#xD;
        also complete questionnaires at each study visit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)</measure>
      <time_frame>baseline, 12 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in bone resorption marker C-terminal telopeptide (CTX)</measure>
      <time_frame>baseline, 6 months, 12 months</time_frame>
      <description>measured using commercially available ELISA test on serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)</measure>
      <time_frame>baseline, 6 months, 12 months</time_frame>
      <description>measured using commercially available ELISA test on serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Trabecular Bone score</measure>
      <time_frame>baseline, 12 months</time_frame>
      <description>measure of bone quality, using DXA spine images</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Osteoporosis</condition>
    <arm_group>
      <arm_group_label>Donepezil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Donepezil</intervention_name>
      <description>10 mg tablet</description>
      <arm_group_label>Donepezil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Donepezil placebo tablet</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of ADRD, including clinical assessment and either radiographic or laboratory&#xD;
               biomarker assessment&#xD;
  &#xD;
            2. Meets NIA-AA clinical dementia criteria&#xD;
  &#xD;
            3. Willing to initiate treatment with AchEI for ADRD&#xD;
  &#xD;
            4. MoCA score &lt; 24&#xD;
  &#xD;
            5. For females, either age &gt; 55 years, or Age &lt; 55 years and at least 12 months since&#xD;
               last menstrual period&#xD;
  &#xD;
            6. For males, age &gt; 50 years&#xD;
  &#xD;
            7. Geriatric Depression Scale score &lt; 6&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Currently on acetylcholinesterase inhibitor&#xD;
  &#xD;
            2. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab,&#xD;
               teripar-atide, abaloparatide, romozosumab)&#xD;
  &#xD;
            3. Use of bisphosphonate within last 2 years&#xD;
  &#xD;
            4. Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or&#xD;
               aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones&#xD;
  &#xD;
            5. History of disorders associated with osteoporosis: collagen vascular diseases,&#xD;
               malab-sorption, inflammatory bowel disease, severe liver disease/cirrhosis,&#xD;
               hyperthyroidism (endogenous or exogenous)&#xD;
  &#xD;
            6. History of hip fracture, hip replacement, or non-ambulatory&#xD;
  &#xD;
            7. Long-term use (&gt;6 months) of corticosteroids&#xD;
  &#xD;
            8. History of Parkinson's, HIV, Huntington's disease&#xD;
  &#xD;
            9. History of solid organ transplantation&#xD;
  &#xD;
           10. Severe kidney impairment (eGFR &lt; 30 ml/sec),&#xD;
  &#xD;
           11. Active malignancy, except non-melanomatous skin cancer&#xD;
  &#xD;
           12. 1-year mortality &gt; 25%, measured by ePrognosis calculator&#xD;
  &#xD;
           13. Initiation of investigational or FDA-approved anti-amyloid drug&#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>Richard H Lee, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Connie Thacker</last_name>
      <phone>(919) 681-9807</phone>
      <email>connie.thacker@duke.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Duke Memory Disorders Clinic</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27705</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Connie Thacker</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Osteoporosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Donepezil</mesh_term>
    </intervention_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/NCT06041789
  org study id: Pro00111080
  secondary id: R21AG078982
  nct id: NCT06041789
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have
        shown that those taking donepezil have a lower rate of bone fractures, but the reasons for
        this are unknown. The purpose of this study is to measure the effect of donepezil treatment
        on bone metabolism factors including bone mineral density, bone turnover markers, and bone
        quality.
  
        Participants in this study will have a bone density test and have blood samples collected at
        the baseline study visit. Participants will then be randomly assigned to donepezil or
        matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at
        6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will
        also complete questionnaires at each study visit.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)
  time frame: baseline, 12 months
  measure: Change in bone resorption marker C-terminal telopeptide (CTX)
  time frame: baseline, 6 months, 12 months
  description: measured using commercially available ELISA test on serum
  measure: Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)
  time frame: baseline, 6 months, 12 months
  description: measured using commercially available ELISA test on serum
  measure: Change in Trabecular Bone score
  time frame: baseline, 12 months
  description: measure of bone quality, using DXA spine images
  arm group label: Donepezil
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Donepezil
  description: 10 mg tablet
  arm group label: Donepezil
  intervention type: Drug
  intervention name: Placebo
  description: Donepezil placebo tablet
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Richard H Lee, MD, MPH
  role: Principal Investigator
  affiliation: Duke University
  last name: Connie Thacker
  phone: (919) 681-9807
  email: connie.thacker@duke.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Osteoporosis
  mesh term: Donepezil
  sharing ipd: No