Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Catania
• Treatments: Metformin; Vildagliptin

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