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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Choline alfoscerate

Study type: Interventional

Funder types: Other

Identifiers

NCT03249259

B-1508-312-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Choline alfoscerate

Experimental group

Description:

choline alfoscerate 400mg (2 caps - 1 cap bid)

Treatment:

Drug: Choline alfoscerate

Control

Placebo Comparator group

Description:

Placebo (2 caps - 1 cap bid)

Treatment:

Drug: Placebo