<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/NCT03801642</url>
  </required_header>
  <id_info>
    <org_study_id>Dapa in AD</org_study_id>
    <nct_id>NCT03801642</nct_id>
  </id_info>
  <brief_title>Dapagliflozin In Alzheimer's Disease</brief_title>
  <official_title>Randomized Controlled Pilot Trial Of Dapagliflozin In Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeff Burns, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a pilot randomized controlled trial in individuals with probable Alzheimer's disease&#xD;
      testing the effects of 10 mg dapagliflozin, taken daily for 12 weeks, on cerebral n-acetyl&#xD;
      aspartate (NAA) levels using magnetic resonance spectroscopy (MRS). The investigators will&#xD;
      also examine the safety and tolerability of dapagliflozin and explore the effects on systemic&#xD;
      NAA levels in blood and urine, cerebral metabolism (fluorodeoxyglucose [FDG] PET), systemic&#xD;
      metabolic biomarkers that indicate and quantify secondary metabolic effects, and cognitive&#xD;
      performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind, randomized, placebo-controlled, parallel group, 12-week study&#xD;
      performed at a single site (University of Kansas Alzheimer's Disease Center) to investigate&#xD;
      the effect of dapagliflozin in participants with probable AD (MMSE 15-26 inclusive). A total&#xD;
      of 48 participants will be enrolled with 2:1 randomization to 10mg dapagliflozin once daily&#xD;
      (n=32) for 12 weeks vs matching placebo (n=16).&#xD;
&#xD;
      The primary objective of the study is to assess the effect of 12 weeks of 10mg dapagliflozin&#xD;
      once daily on cerebral NAA (a proxy measure of mitochondrial mass) in participants with AD.&#xD;
&#xD;
      Procedures will include phlebotomy, urine collection, MRI/MRS, FDG-PET, cognitive testing,&#xD;
      DEXA scanning, and indirect calorimetry at baseline and 12 weeks to assess these outcomes:&#xD;
&#xD;
        -  N Acetyl-Aspartate (NAA): Cerebral NAA (as measured by MRS) and Systemic NAA levels (in&#xD;
           blood and urine)&#xD;
&#xD;
        -  Cerebral metabolism (by FDG PET)&#xD;
&#xD;
        -  Systemic metabolic effects: Lipids (total cholesterol, LDL, HDL), Plasma&#xD;
           beta-hydroxybutyrate, Insulin resistance (Hemoglobin A1c, glucose and insulin during&#xD;
           tolerance testing), Catabolic/Anabolic state [activated AKT and MTOR], Mitochondrial&#xD;
           function measures [platelet cytochrome oxidase and citrate synthase], Inflammatory&#xD;
           mechanisms [MCP-1, eotaxin, TNF alpha, CRP], Body composition (DEXA scanning for fat and&#xD;
           lean mass), Resting metabolic rate (indirect calorimetry),&#xD;
&#xD;
        -  Cognitive effects will be assessed at baseline and week 12 using the Alzheimer's Disease&#xD;
           Assessment Scale-Cognitive Subscale 14 (ADAS-Cog14) and individual tests of Logical&#xD;
           Memory I and II, Trailmaking A and B, and Stroop Word Color Test.&#xD;
&#xD;
        -  12 participants will be enrolled in an optional MRI/MRS sub-study with repeat MRI/MRS&#xD;
           prior to randomization to assess scan-rescan reliability of the NAA measure.&#xD;
&#xD;
      Safety and tolerability of dapagliflozin (10mg daily) will be monitored throughout the study&#xD;
      and formally at every study visit to assess the incidence and severity of AEs and the rate of&#xD;
      discontinuations due to AEs. Safety assessments will include measuring vital signs and body&#xD;
      weight, safety labs (including a comprehensive metabolic panel [CMP] and complete blood count&#xD;
      [CBC] with differential) and physical and neurological examinations at screening and at end&#xD;
      of treatment (EOT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">July 7, 2022</completion_date>
  <primary_completion_date type="Actual">July 7, 2022</primary_completion_date>
  <phase>Phase 1/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>Cerebral N Acetyl-Aspartate (NAA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cerebral NAA concentration via Magnetic Resonance Spectroscopy (MRS)</description>
  </primary_outcome>
  <other_outcome>
    <measure>Systemic NAA levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>NAA concentration levels in blood and urine using UPLC-MS/MS method</description>
  </other_outcome>
  <other_outcome>
    <measure>FDG PET Metabolism (Standard Uptake Value Ratio)</measure>
    <time_frame>12 weeks</time_frame>
    <description>FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) will be calculated from native-space ROIs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total cholesterol level</description>
  </other_outcome>
  <other_outcome>
    <measure>LDL Cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>LDL cholesterol level</description>
  </other_outcome>
  <other_outcome>
    <measure>HDL Cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>HDL cholesterol level</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma beta-hydroxybutyrate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Plasma beta-hydroxybuteryate levels (ketones)</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hemoglobin A1C</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose Area Under the Curve</measure>
    <time_frame>12 weeks</time_frame>
    <description>Glucose area under the curve will be calculated based on glucose levels during a 120 minute oral glucose tolerance test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin Area Under the Curve</measure>
    <time_frame>12 weeks</time_frame>
    <description>Insulin area under the curve will be calculated based on insulin levels during a 120 minute oral glucose tolerance test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Activated AKT levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Activated AKT will be measured in lymphocytes immunochemically.</description>
  </other_outcome>
  <other_outcome>
    <measure>MTOR Phosphorylation</measure>
    <time_frame>12 weeks</time_frame>
    <description>MTOR phosphorylation will be measured in lymphocytes</description>
  </other_outcome>
  <other_outcome>
    <measure>Platelet Cytochrome Oxidase activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cytochrome Oxidase Vmax activity is determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocyte Chemotactic Protein 1 (MCP-1)</measure>
    <time_frame>12 weeks</time_frame>
    <description>MCP-1, a measure of inflammation, will be measured in platelet free plasma using ELISA.</description>
  </other_outcome>
  <other_outcome>
    <measure>Eotaxin-1</measure>
    <time_frame>12 weeks</time_frame>
    <description>Eotaxin-1, a measure of inflammation, will be measured in platelet free plasma using ELISA.</description>
  </other_outcome>
  <other_outcome>
    <measure>Tumor Necrosis Factor (TNF) - alpha</measure>
    <time_frame>12 weeks</time_frame>
    <description>TNF-alpha, a measure of inflammation, will be measured in platelet free plasma using ELISA.</description>
  </other_outcome>
  <other_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>12 weeks</time_frame>
    <description>CRP, a measure of inflammation, will be measured in platelet free plasma using ELISA.</description>
  </other_outcome>
  <other_outcome>
    <measure>Total fat mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body composition will be assessed using dual energy x-ray absorptiometry (GE Lunar iDEXA) to determine fat-free mass, fat mass, and percent body fat at baseline, and week 12</description>
  </other_outcome>
  <other_outcome>
    <measure>Total lean mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body composition will be assessed using dual energy x-ray absorptiometry (GE Lunar iDEXA) to determine fat-free mass, fat mass, and percent body fat at baseline, and week 12</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting Metabolic Rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Resting metabolic rate will be assessed using indirect calorimetry which measures CO2 production and O2 consumption to calculate total energy produced.</description>
  </other_outcome>
  <other_outcome>
    <measure>ADAS-Cog 14</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cognitive performance as measured by total score on the ADAS-cog 14.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trailmaking B</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cognitive performance as measured by Trailmaking B</description>
  </other_outcome>
  <other_outcome>
    <measure>Stroop Word Color Test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cognitive performance on the Stroop Word Color test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Logical Memory II</measure>
    <time_frame>12 weeks</time_frame>
    <description>Memory performance as measured by the Logical Memory II test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>14 weeks</time_frame>
    <description>Total number of adverse events considered related to the study medication</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Discontinuations due to Adverse Events</measure>
    <time_frame>14 weeks</time_frame>
    <description>Number of participants who stop taking the study medication due to adverse events</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg dapagliflozin oral tablet taken once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral tablet taken once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>10 mg oral tablets taken once daily for 12 weeks</description>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <other_name>Farxiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet (matched in size and color to active tablet) taken once daily for 12 weeks</description>
    <arm_group_label>Matching placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures.&#xD;
&#xD;
          2. Have a diagnosis of probable AD per McKhann et al. criteria&#xD;
&#xD;
          3. Have a body mass index (BMI) ≥23&#xD;
&#xD;
          4. Age 50-85&#xD;
&#xD;
          5. Have a Mini Mental Status Exam (MMSE) score of 15-26 (inclusive) at screening visit&#xD;
&#xD;
          6. Have a reliable and competent study partner who is willing to accompany the&#xD;
             participant to all study visits, monitor compliance of study medication&#xD;
             administration, and observe/report any changes in the participant's health throughout&#xD;
             the study duration&#xD;
&#xD;
          7. Are on stable doses of concurrent medications for at least 4 weeks prior to the&#xD;
             screening visit&#xD;
&#xD;
          8. Speaks English as his/her primary language.&#xD;
&#xD;
          9. Females of child-bearing potential (i.e., pre-menopausal) must have a negative urine&#xD;
             pregnancy test at the screening visit and must agree to use of contraception&#xD;
             throughout the trial and for 30 days after the last dose of study medication. The&#xD;
             approved methods of contraception are abstinence, the consistent use of an approved&#xD;
             oral contraceptive (birth control pill or &quot;the pill&quot;), an intrauterine device (IUD),&#xD;
             hormonal implants, contraceptive injection, double barrier method (diaphragm with&#xD;
             spermicidal gel or condom with contraceptive foam).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received an investigational product in another clinical study during the last 4 weeks&#xD;
             prior to screening&#xD;
&#xD;
          2. Diagnosis of Type 1 diabetes&#xD;
&#xD;
          3. Diagnosis of Type 2 diabetes treated with insulin, sulfonylureas, glucagon like&#xD;
             peptide1 receptor agonists (GLP-1), thiazolidinedione (TZD) or SGLT2 inhibitors&#xD;
             (metformin monotherapy is allowed).&#xD;
&#xD;
          4. Estimated Glomerular Filtration Rate (eGFR; MDRD) &lt;45 mL/min at screening or unstable&#xD;
             renal disease.&#xD;
&#xD;
          5. Any condition when MRI is contraindicated such as, but not limited to, having a&#xD;
             pacemaker or claustrophobia.&#xD;
&#xD;
          6. Severe hepatic injury and/or significant abnormal liver function defined as aspartate&#xD;
             aminotransferase (AST) &gt;3x upper limit of normal (ULN) and/or alanine aminotransferase&#xD;
             (ALT) &gt;3x ULN. Total bilirubin &gt;2.0 mg/dL (34.2 μmol/L)&#xD;
&#xD;
          7. Intolerance or allergy to dapaglifozin or any other SGLT2 inhibitor or any other&#xD;
             substance in the tablets.&#xD;
&#xD;
          8. Dementia due to causes other than AD&#xD;
&#xD;
          9. History of recurrent urinary tract infection&#xD;
&#xD;
         10. Active mycotic genital infection&#xD;
&#xD;
         11. History of bladder cancer&#xD;
&#xD;
         12. History of diabetic ketoacidosis&#xD;
&#xD;
         13. Potentially confounding, serious, or unstable medical conditions such as:&#xD;
&#xD;
               1. cancer within the past 3 years (except basal cell, squamous cell, or localized&#xD;
                  prostate cancer)&#xD;
&#xD;
               2. a recent cardiac event (i.e. heart attack, angioplasty, etc. within the 3 months&#xD;
                  prior to screening visit)&#xD;
&#xD;
               3. other conditions that pose a potential safety risk or confounding factor in the&#xD;
                  investigator's opinion&#xD;
&#xD;
         14. Any abnormal physical examination assessment or vital sign assessment at the screening&#xD;
             visit that is deemed to be clinically significant by the principal investigator.&#xD;
&#xD;
         15. Any abnormal clinical laboratory test result at the screening visit that is deemed to&#xD;
             be clinically significant by the principal investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Burns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Jeff Burns, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 6, 2023</submitted>
    <returned>July 25, 2023</returned>
  </pending_results>
  <!-- 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/NCT03801642
org study id: Dapa in AD
nct id: NCT03801642
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a pilot randomized controlled trial in individuals with probable Alzheimer's disease
      testing the effects of 10 mg dapagliflozin, taken daily for 12 weeks, on cerebral n-acetyl
      aspartate (NAA) levels using magnetic resonance spectroscopy (MRS). The investigators will
      also examine the safety and tolerability of dapagliflozin and explore the effects on systemic
      NAA levels in blood and urine, cerebral metabolism (fluorodeoxyglucose [FDG] PET), systemic
      metabolic biomarkers that indicate and quantify secondary metabolic effects, and cognitive
      performance.
This is a double-blind, randomized, placebo-controlled, parallel group, 12-week study
      performed at a single site (University of Kansas Alzheimer's Disease Center) to investigate
      the effect of dapagliflozin in participants with probable AD (MMSE 15-26 inclusive). A total
      of 48 participants will be enrolled with 2:1 randomization to 10mg dapagliflozin once daily
      (n=32) for 12 weeks vs matching placebo (n=16).

      The primary objective of the study is to assess the effect of 12 weeks of 10mg dapagliflozin
      once daily on cerebral NAA (a proxy measure of mitochondrial mass) in participants with AD.

      Procedures will include phlebotomy, urine collection, MRI/MRS, FDG-PET, cognitive testing,
      DEXA scanning, and indirect calorimetry at baseline and 12 weeks to assess these outcomes:

        -  N Acetyl-Aspartate (NAA): Cerebral NAA (as measured by MRS) and Systemic NAA levels (in
           blood and urine)

        -  Cerebral metabolism (by FDG PET)

        -  Systemic metabolic effects: Lipids (total cholesterol, LDL, HDL), Plasma
           beta-hydroxybutyrate, Insulin resistance (Hemoglobin A1c, glucose and insulin during
           tolerance testing), Catabolic/Anabolic state [activated AKT and MTOR], Mitochondrial
           function measures [platelet cytochrome oxidase and citrate synthase], Inflammatory
           mechanisms [MCP-1, eotaxin, TNF alpha, CRP], Body composition (DEXA scanning for fat and
           lean mass), Resting metabolic rate (indirect calorimetry),

        -  Cognitive effects will be assessed at baseline and week 12 using the Alzheimer's Disease
           Assessment Scale-Cognitive Subscale 14 (ADAS-Cog14) and individual tests of Logical
           Memory I and II, Trailmaking A and B, and Stroop Word Color Test.

        -  12 participants will be enrolled in an optional MRI/MRS sub-study with repeat MRI/MRS
           prior to randomization to assess scan-rescan reliability of the NAA measure.

      Safety and tolerability of dapagliflozin (10mg daily) will be monitored throughout the study
      and formally at every study visit to assess the incidence and severity of AEs and the rate of
      discontinuations due to AEs. Safety assessments will include measuring vital signs and body
      weight, safety labs (including a comprehensive metabolic panel [CMP] and complete blood count
      [CBC] with differential) and physical and neurological examinations at screening and at end
      of treatment (EOT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cerebral N Acetyl-Aspartate (NAA)
time frame: 12 weeks
description: Cerebral NAA concentration via Magnetic Resonance Spectroscopy (MRS)
measure: Systemic NAA levels
time frame: 12 weeks
description: NAA concentration levels in blood and urine using UPLC-MS/MS method
measure: FDG PET Metabolism (Standard Uptake Value Ratio)
time frame: 12 weeks
description: FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) will be calculated from native-space ROIs.
measure: Total Cholesterol
time frame: 12 weeks
description: Total cholesterol level
measure: LDL Cholesterol
time frame: 12 weeks
description: LDL cholesterol level
measure: HDL Cholesterol
time frame: 12 weeks
description: HDL cholesterol level
measure: Plasma beta-hydroxybutyrate
time frame: 12 weeks
description: Plasma beta-hydroxybuteryate levels (ketones)
measure: Hemoglobin A1C
time frame: 12 weeks
description: Hemoglobin A1C
measure: Glucose Area Under the Curve
time frame: 12 weeks
description: Glucose area under the curve will be calculated based on glucose levels during a 120 minute oral glucose tolerance test.
measure: Insulin Area Under the Curve
time frame: 12 weeks
description: Insulin area under the curve will be calculated based on insulin levels during a 120 minute oral glucose tolerance test.
measure: Activated AKT levels
time frame: 12 weeks
description: Activated AKT will be measured in lymphocytes immunochemically.
measure: MTOR Phosphorylation
time frame: 12 weeks
description: MTOR phosphorylation will be measured in lymphocytes
measure: Platelet Cytochrome Oxidase activity
time frame: 12 weeks
description: Cytochrome Oxidase Vmax activity is determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm
measure: Monocyte Chemotactic Protein 1 (MCP-1)
time frame: 12 weeks
description: MCP-1, a measure of inflammation, will be measured in platelet free plasma using ELISA.
measure: Eotaxin-1
time frame: 12 weeks
description: Eotaxin-1, a measure of inflammation, will be measured in platelet free plasma using ELISA.
measure: Tumor Necrosis Factor (TNF) - alpha
time frame: 12 weeks
description: TNF-alpha, a measure of inflammation, will be measured in platelet free plasma using ELISA.
measure: C-Reactive Protein (CRP)
time frame: 12 weeks
description: CRP, a measure of inflammation, will be measured in platelet free plasma using ELISA.
measure: Total fat mass
time frame: 12 weeks
description: Body composition will be assessed using dual energy x-ray absorptiometry (GE Lunar iDEXA) to determine fat-free mass, fat mass, and percent body fat at baseline, and week 12
measure: Total lean mass
time frame: 12 weeks
description: Body composition will be assessed using dual energy x-ray absorptiometry (GE Lunar iDEXA) to determine fat-free mass, fat mass, and percent body fat at baseline, and week 12
measure: Resting Metabolic Rate
time frame: 12 weeks
description: Resting metabolic rate will be assessed using indirect calorimetry which measures CO2 production and O2 consumption to calculate total energy produced.
measure: ADAS-Cog 14
time frame: 12 weeks
description: Cognitive performance as measured by total score on the ADAS-cog 14.
measure: Trailmaking B
time frame: 12 weeks
description: Cognitive performance as measured by Trailmaking B
measure: Stroop Word Color Test
time frame: 12 weeks
description: Cognitive performance on the Stroop Word Color test.
measure: Logical Memory II
time frame: 12 weeks
description: Memory performance as measured by the Logical Memory II test.
measure: Number of Adverse Events
time frame: 14 weeks
description: Total number of adverse events considered related to the study medication
measure: Number of Discontinuations due to Adverse Events
time frame: 14 weeks
description: Number of participants who stop taking the study medication due to adverse events
arm group label: Dapagliflozin
arm group type: Experimental
description: 10 mg dapagliflozin oral tablet taken once daily for 12 weeks
arm group label: Matching placebo
arm group type: Placebo Comparator
description: Placebo oral tablet taken once daily for 12 weeks
intervention type: Drug
intervention name: Dapagliflozin
description: 10 mg oral tablets taken once daily for 12 weeks
arm group label: Dapagliflozin
other name: Farxiga
intervention type: Other
intervention name: Placebo
description: Placebo tablet (matched in size and color to active tablet) taken once daily for 12 weeks
arm group label: Matching placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jeffrey Burns, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Jeff Burns, MD
investigator title: Professor
mesh term: Alzheimer Disease
mesh term: Dapagliflozin
sharing ipd: No
submitted: July 6, 2023
returned: July 25, 2023