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

NCT ID: NCT03249259

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-10

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double blind placebo controlled study.

Study Groups

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Choline alfoscerate

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

Group Type EXPERIMENTAL

Choline alfoscerate

Intervention Type DRUG

Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Control

Placebo (2 caps - 1 cap bid)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Interventions

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Choline alfoscerate

Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Intervention Type DRUG

Placebo

Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Intervention Type DRUG

Other Intervention Names

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Choline

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1508-312-006

Identifier Type: -

Identifier Source: org_study_id

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