Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

Phase 4CompletedNCT03819127

University of Catania60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Vildagliptin 50 MG Oral TabletDRUG

Metformin PillDRUG

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 24 weeks

Secondary Outcomes

Rate of Glycated hemoglobin (%)

Laboratory assessment of Glycated hemoglobin

Time frame: 24 weeks

Data from ClinicalTrials.gov

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