Status:
RECRUITING
Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
SK Chemicals Co., Ltd.
Conditions:
Type 2 Diabets Mellitus
Cognitive Ability, General
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
This exploratory pilot study aims to evaluate the cognitive improvement effects of combination therapy with cilostazol (200 mg) and ginkgo biloba extract (160 mg) in elderly patients with type 2 diabe...
Eligibility Criteria
Inclusion
- Patients diagnosed with type 2 diabetes mellitus
- Adults aged 60 years or older
- Patients with a Mini-Mental State Examination (MMSE) score between 24 and 28 within the past 3 months
Exclusion
- Patients with type 1 diabetes mellitus, diabetic ketoacidosis, or diabetic coma or precoma
- Patients with poorly controlled blood glucose (HbA1c \> 10.0%)
- Patients with an MMSE score below 24
- Patients diagnosed with dementia (e.g., Alzheimer's disease)
- Patients with suspected cognitive impairment due to other causes
- Patients requiring antiplatelet or anticoagulant therapy other than the investigational product
- Patients with thyroid dysfunction requiring treatment (i.e., abnormal TSH levels)
- Patients with severe depression
- Patients with severe infections, recent surgery (perioperative status), or major trauma
- Patients with pituitary or adrenal insufficiency
- Patients with other medical conditions requiring hospitalization
- Patients with a history of alcohol or drug abuse within 1 year prior to screening
- Patients with a history of taking medications that may affect cognitive function within 3 months prior to screening
- Patients deemed by the investigator to be otherwise unsuitable for study participation
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06989697
Start Date
January 1 2025
End Date
June 30 2027
Last Update
May 25 2025
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea