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
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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COMPLETED
PHASE3
36 participants
INTERVENTIONAL
2016-03-10
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Choline alfoscerate
choline alfoscerate 400mg (2 caps - 1 cap bid)
Choline alfoscerate
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Control
Placebo (2 caps - 1 cap bid)
Placebo
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.
Placebo
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* baseline MMSE score 25-28
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Soo Lim
Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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B-1508-312-006
Identifier Type: -
Identifier Source: org_study_id
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