RecruitingPhase 3NCT06989697

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes


Sponsor

Seoul National University Bundang Hospital

Enrollment

80 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 diabetes mellitus. Both agents have demonstrated potential cognitive benefits through mechanisms such as enhanced cerebral blood flow, anti-inflammatory activity, and neuroprotection. Given the increased risk of cognitive decline and dementia in patients with type 2 diabetes, and the need for preventive strategies, this study will investigate whether the combination therapy can prevent or mitigate cognitive deterioration. Findings from this study may provide foundational data for the future development of therapeutic interventions targeting cognitive impairment in patients with diabetes.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two drugs — cilostazol and ginkgo extract — can help protect or improve cognitive function (thinking and memory) in older adults with type 2 diabetes who are showing early signs of mild cognitive decline. **You may be eligible if...** - You are 60 or older - You have been diagnosed with type 2 diabetes - Your cognitive score (MMSE) is between 24 and 28 (mild decline, but not dementia) **You may NOT be eligible if...** - You have type 1 diabetes, diabetic ketoacidosis, or diabetic coma - Your blood sugar is very poorly controlled (HbA1c above 10%) - Your MMSE score is below 24 (more severe cognitive impairment) - You have been diagnosed with dementia (e.g., Alzheimer's disease) - You need antiplatelet or anticoagulant medications other than the study drugs - You have untreated thyroid disease, severe depression, or severe infection Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCilostazol / Ginko Leaf Dried Ext.

Patients will receive a light green, oval-shaped, sustained-release film-coated tablet containing a combination of cilostazol (200 mg) and ginkgo biloba extract (160 mg), administered orally once daily.

DRUGPlacebo

Patients will receive a placebo identical in taste, aroma, and formulation to the active treatment, administered orally once daily.


Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

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NCT06989697


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