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Recruiting Phase 3 NCT06989697

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

Trial Parameters

Condition Type 2 Diabets Mellitus
Sponsor Seoul National University Bundang Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 80
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2025-01-01
Completion 2026-12-31
Interventions
Cilostazol / Ginko Leaf Dried Ext.Placebo

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 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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 hist

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