Actively Recruiting
Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes
Led by Seoul National University Bundang Hospital · Updated on 2025-05-25
80
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
S
SK Chemicals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the potential cognitive benefits of a combination therapy using cilostazol (200 mg) and ginkgo biloba extract (160 mg) in older adults with type 2 diabetes mellitus. This study is a phase 3, randomized trial focusing on whether this treatment can help prevent or reduce cognitive decline, given the higher risk of dementia in people with diabetes. The study aims to provide important data for future treatments targeting cognitive impairment in this population. Participants will be randomly assigned to receive either the combination therapy or a placebo. The active treatment involves taking a sustained-release tablet once daily containing both cilostazol and ginkgo biloba extract. The placebo group will take a similar-looking tablet without the active ingredients. This treatment phase lasts for 6 months. During the study, participants will undergo regular assessments including cognitive tests such as the Mini-Mental State Examination (MMSE), Korean Dementia Screening Questionnaire, Montreal Cognitive Assessment, and Global Deterioration Scale. Health-related quality of life will also be measured using the Short Form-36 survey. Researchers will monitor changes in these measures from the start to the end of the 6-month period to evaluate cognitive improvement and safety.
CONDITIONS
Brief Title
Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily oral tablets of either cilostazol with ginkgo biloba extract or placebo to assess effects on cognitive function.
Monthly visits for 6 months
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Actively Recruiting
Research Team
S
Soo Lim Dr., MD PhD
M
Minji Sohn Dr, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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