- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249259
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
October 4, 2019 updated by: Soo Lim, Seoul National University Bundang Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi
-
Seongnam, Gyeonggi, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Choline alfoscerate
choline alfoscerate 400mg (2 caps - 1 cap bid)
|
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Other Names:
|
PLACEBO_COMPARATOR: Control
Placebo (2 caps - 1 cap bid)
|
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 6 months
|
Change of MMSE Score
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose metabolism
Time Frame: 6 months
|
Changes in HbA1c
|
6 months
|
Glucose metabolism
Time Frame: 6 months
|
Changes in fasting glucose concentration
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypoglycemia
Time Frame: 6 months
|
Incidence of hypoglycemia
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 10, 2016
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ACTUAL)
September 30, 2019
Study Registration Dates
First Submitted
August 9, 2017
First Submitted That Met QC Criteria
August 11, 2017
First Posted (ACTUAL)
August 15, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1508-312-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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