Mild Cognitive Impairment
Conditions
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.
Interventions
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Glycated hemoglobin (%) | 24 weeks | Laboratory assessment of Glycated hemoglobin |
Outcome results
None listed