Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

Phase 4

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Metformin Pill; Drug: Vildagliptin 50 MG Oral Tablet

• Registration Number: NCT03819127
• Lead Sponsor: University of Catania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Study First Posted: 2019-01-28
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin Pill	metformin 1 g twice a day for 24 weeks
Metformin plus vildagliptin	Vildagliptin 50 MG Oral Tablet	metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
Metformin plus vildagliptin	Metformin Pill	metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks

Primary Outcome Measures

Name	Time	Method
Evaluation of cognitive decline	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

Name	Time	Method
Rate of Glycated hemoglobin (%)	24 weeks	Laboratory assessment of Glycated hemoglobin