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Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vildagliptin 50 MG Oral Tablet
Metformin Pill
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age >65 years
  • MMSE score ≥18 and ≤23
  • diagnosis of diabetes mellitus

Exclusion Criteria:

  • heart failure
  • coronary heart disease
  • stroke
  • chronic kidney disease (G3 grade KDOQI)
  • liver cirrhosis
  • chronic respiratory failure
  • depression evaluated by Geriatric Depression (GDS, GDS >15)
  • diagnosis of dementia based on DSM 5 criteria
  • anticholinesterase or memantine therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Metformin

    Metformin plus vildagliptin

    Arm Description

    metformin 1 g twice a day for 24 weeks

    metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks

    Outcomes

    Primary Outcome Measures

    Evaluation of cognitive decline
    Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI).

    Secondary Outcome Measures

    Rate of Glycated hemoglobin (%)
    Laboratory assessment of Glycated hemoglobin

    Full Information

    First Posted
    January 22, 2019
    Last Updated
    January 25, 2019
    Sponsor
    University of Catania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03819127
    Brief Title
    Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment
    Official Title
    Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Catania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metformin
    Arm Type
    Active Comparator
    Arm Description
    metformin 1 g twice a day for 24 weeks
    Arm Title
    Metformin plus vildagliptin
    Arm Type
    Experimental
    Arm Description
    metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Vildagliptin 50 MG Oral Tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin Pill
    Primary Outcome Measure Information:
    Title
    Evaluation of cognitive decline
    Description
    Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI).
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Rate of Glycated hemoglobin (%)
    Description
    Laboratory assessment of Glycated hemoglobin
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age >65 years MMSE score ≥18 and ≤23 diagnosis of diabetes mellitus Exclusion Criteria: heart failure coronary heart disease stroke chronic kidney disease (G3 grade KDOQI) liver cirrhosis chronic respiratory failure depression evaluated by Geriatric Depression (GDS, GDS >15) diagnosis of dementia based on DSM 5 criteria anticholinesterase or memantine therapy

    12. IPD Sharing Statement

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