Status:
COMPLETED
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 exten...
Eligibility Criteria
Inclusion
- type 2 diabetes
- baseline MMSE score 25-28
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03249259
Start Date
March 10 2016
End Date
September 30 2019
Last Update
October 8 2019
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707