Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin 50 mg Oral Tablet

Drug

Metformin Pill

Drug

Primary outcomes

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 outcomes

Rate of Glycated hemoglobin (%)

Time frame: 24 weeks

Laboratory assessment of Glycated hemoglobin

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 28, 2019
Registry last updated: Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed