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Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT03819127
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Enzo Saretto Dante Vicari, University of Catania

Study Description
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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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Vildagliptin 50 MG Oral Tablet Drug: Metformin Pill Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment
Actual Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Metformin
metformin 1 g twice a day for 24 weeks
 Drug: Metformin Pill
Experimental: Metformin plus vildagliptin
metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
 Drug: Vildagliptin 50 MG Oral Tablet
Drug: Metformin Pill


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of cognitive decline [ Time Frame: 24 weeks ]
    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 :
  1. Rate of Glycated hemoglobin (%) [ Time Frame: 24 weeks ]
    Laboratory assessment of Glycated hemoglobin


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Enzo Saretto Dante Vicari, Associate Professor, University of Catania
ClinicalTrials.gov Identifier: NCT03819127    
Other Study ID Numbers: 01/2015
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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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
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Metformin
Vildagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action