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NCT03249259 Clinical Trial

The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03249259
Other study ID # B-1508-312-006
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 10, 2016
Est. completion date September 30, 2019

Study information
Verified date October 2019
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 36
Est. completion date September 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Choline alfoscerate
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
• Placebo
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Hypoglycemia Incidence of hypoglycemia 6 months
Primary Cognitive function Change of MMSE Score 6 months
Secondary Glucose metabolism Changes in HbA1c 6 months
Secondary Glucose metabolism Changes in fasting glucose concentration 6 months
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