The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo
- Registration Number
- NCT03249259
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.
- Detailed Description
The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- type 2 diabetes
- baseline MMSE score 25-28
Exclusion Criteria
- type 1 diabetes
- diabetes ketoacidosis or hyperosmolar hyperglycemic crisis
- HbA1c over than 9.0%
- MMSE less than 25
- abnormal TSH levels
- vitamin B12 deficiency
- severe infection, perioperative state, trauma
- hypopituitarism or adrenal insufficiency
- any conditions that lead to hospitalization
- chronic alcoholics within 1 year
- any drugs that can influence to cognitive function within 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo Placebo (2 caps - 1 cap bid) Choline alfoscerate Choline alfoscerate choline alfoscerate 400mg (2 caps - 1 cap bid)
- Primary Outcome Measures
Name Time Method Cognitive function 6 months Change of MMSE Score
- Secondary Outcome Measures
Name Time Method Glucose metabolism 6 months Changes in fasting glucose concentration
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of