Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819127
• Other study ID #: 01/2015
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2019
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Vildagliptin 50 MG Oral Tablet

• Metformin Pill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 weeks
Secondary	Rate of Glycated hemoglobin (%)	Laboratory assessment of Glycated hemoglobin	24 weeks