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Clinical Trials in South Korea / NCT06989697
Recruiting Phase 3

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

NCT06989697 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Bundang Hospital
Phase
Phase 3
Started
2025-01-01
Last updated
2025-05-25

Condition(s) studied

Type 2 Diabets MellitusCognitive Ability, General

Investigational drug(s) / intervention(s)

Cilostazol / Ginko Leaf Dried Ext.Placebo

Cilostazol / 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.

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

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months — 6 months
    The MMSE is a widely used test of cognitive function among the elderly. It includes tests of orientation, attention, memory, language, and visual-spatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive function. A change in total MMSE score from baseline to 6 months will be assessed.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06989697 on ClinicalTrials.gov ↗ ← All trials in South Korea