NCT03249259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

August 9, 2017

Last Update Submit

October 4, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Change of MMSE Score

    6 months

Secondary Outcomes (2)

  • Glucose metabolism

    6 months

  • Glucose metabolism

    6 months

Other Outcomes (1)

  • Hypoglycemia

    6 months

Study Arms (2)

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

Choline alfoscerateDRUG

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

Also known as: Choline
Choline alfoscerate
PlaceboDRUG

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

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • baseline MMSE score 25-28

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

GlycerylphosphorylcholineCholine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GlycerophosphatesTriose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesGlycerophospholipidsPhosphatidic AcidsPhospholipidsMembrane LipidsLipidsLecithinsPhosphatidylcholinesEthanolaminesAmino AlcoholsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind placebo controlled study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 15, 2017

Study Start

March 10, 2016

Primary Completion

June 30, 2019

Study Completion

September 30, 2019

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)