<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/NCT03819127</url>
  </required_header>
  <id_info>
    <org_study_id>01/2015</org_study_id>
    <nct_id>NCT03819127</nct_id>
  </id_info>
  <brief_title>Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment</brief_title>
  <official_title>Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Catania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Catania</source>
  <oversight_info>
    <is_fda_regulated_drug>No</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 study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the&#xD;
      cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI)&#xD;
      documented at mini mental state examination (MMSE).&#xD;
&#xD;
      In this prospective study, 60 diabetic elderly people were enrolled and divided according to&#xD;
      their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c &lt;7.5%, n=30) treated&#xD;
      with metformin, and Group B (HbA1c &gt;7.5%, n=30) treated with metformin plus vildagliptin. We&#xD;
      evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of cognitive decline</measure>
    <time_frame>24 weeks</time_frame>
    <description>Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Glycated hemoglobin (%)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Laboratory assessment of Glycated hemoglobin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>metformin 1 g twice a day for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin plus vildagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin 50 MG Oral Tablet</intervention_name>
    <arm_group_label>Metformin plus vildagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin Pill</intervention_name>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_label>Metformin plus vildagliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;65 years&#xD;
&#xD;
          -  MMSE score ≥18 and ≤23&#xD;
&#xD;
          -  diagnosis of diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  coronary heart disease&#xD;
&#xD;
          -  stroke&#xD;
&#xD;
          -  chronic kidney disease (G3 grade KDOQI)&#xD;
&#xD;
          -  liver cirrhosis&#xD;
&#xD;
          -  chronic respiratory failure&#xD;
&#xD;
          -  depression evaluated by Geriatric Depression (GDS, GDS &gt;15)&#xD;
&#xD;
          -  diagnosis of dementia based on DSM 5 criteria&#xD;
&#xD;
          -  anticholinesterase or memantine therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Catania</investigator_affiliation>
    <investigator_full_name>Enzo Saretto Dante Vicari</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Vildagliptin</mesh_term>
  </intervention_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/NCT03819127
org study id: 01/2015
nct id: NCT03819127
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the
      cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI)
      documented at mini mental state examination (MMSE).

      In this prospective study, 60 diabetic elderly people were enrolled and divided according to
      their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c <7.5%, n=30) treated
      with metformin, and Group B (HbA1c >7.5%, n=30) treated with metformin plus vildagliptin. We
      evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Evaluation of cognitive decline
time frame: 24 weeks
description: Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI).
measure: Rate of Glycated hemoglobin (%)
time frame: 24 weeks
description: Laboratory assessment of Glycated hemoglobin
arm group label: Metformin
arm group type: Active Comparator
description: metformin 1 g twice a day for 24 weeks
arm group label: Metformin plus vildagliptin
arm group type: Experimental
description: metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
intervention type: Drug
intervention name: Vildagliptin 50 MG Oral Tablet
arm group label: Metformin plus vildagliptin
intervention type: Drug
intervention name: Metformin Pill
arm group label: Metformin
arm group label: Metformin plus vildagliptin
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Catania
investigator full name: Enzo Saretto Dante Vicari
investigator title: Associate Professor
mesh term: Cognitive Dysfunction
mesh term: Metformin
mesh term: Vildagliptin