The Effect of Choline Alfoscerate on Improvement of Cogni... | NCT03249259

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

NCT03249259

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Oct 8, 2019Actual

Enrollment

36Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Choline alfoscerate
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2016Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Aug 9, 2017

First Submission Date that Met QC Criteria

Aug 11, 2017

First Posted Date

Aug 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2019

Last Update Posted Date

Oct 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo Lim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Choline alfoscerate	Experimental	choline alfoscerate 400mg (2 caps - 1 cap bid)	Drug: Choline alfoscerate
Control	Placebo Comparator	Placebo (2 caps - 1 cap bid)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Choline alfoscerate	Drug	Treatment duration is 6 months and can be extended to 12 months with participant's agreement.	Choline alfoscerate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function	Change of MMSE Score	6 months

Secondary Outcomes

Measure	Description	Time Frame
Glucose metabolism	Changes in HbA1c	6 months
Glucose metabolism	Changes in fasting glucose concentration	6 months

Other Outcomes

Measure	Description	Time Frame
Hypoglycemia	Incidence of hypoglycemia	6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005997	Glycerylphosphorylcholine
D002794	Choline

Ancestor Terms

ID	Term
D005994	Glycerophosphates
D000073999	Triose Sugar Alcohols
D013402	Sugar Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided