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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Choline alfoscerate
Placebo
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline alfoscerate

Control

Arm Description

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

Placebo (2 caps - 1 cap bid)

Outcomes

Primary Outcome Measures

Cognitive function
Change of MMSE Score

Secondary Outcome Measures

Glucose metabolism
Changes in HbA1c
Glucose metabolism
Changes in fasting glucose concentration

Full Information

First Posted
August 9, 2017
Last Updated
October 4, 2019
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03249259
Brief Title
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Official Title
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind placebo controlled study.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Choline alfoscerate
Arm Type
Experimental
Arm Description
choline alfoscerate 400mg (2 caps - 1 cap bid)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo (2 caps - 1 cap bid)
Intervention Type
Drug
Intervention Name(s)
Choline alfoscerate
Other Intervention Name(s)
Choline
Intervention Description
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Primary Outcome Measure Information:
Title
Cognitive function
Description
Change of MMSE Score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glucose metabolism
Description
Changes in HbA1c
Time Frame
6 months
Title
Glucose metabolism
Description
Changes in fasting glucose concentration
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Hypoglycemia
Description
Incidence of hypoglycemia
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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