Recruiting

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

ClinicalTrials.gov IDNCT06989697

PhasePHASE3

Enrollment80

SponsorSeoul National University Bundang Hospital

Age60 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabets Mellitus, Cognitive Ability, General

About this study

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.

Interventions

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

Primary outcomes

Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months (6 months)

Eligibility information

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

Study locations

Seoul National University Bundang Hospital, Seongnam-si, South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.