Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

Seoul National University

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabets Mellitus; Cognitive Ability, General

Treatments: Drug: Placebo; Drug: Cilostazol / Ginko Leaf Dried Ext.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06989697

B-2402-880-001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Cilostazol & Ginko Leaf Dried Ext.

Experimental group

Description:

Renexin CR tab (cilostazol 200mg / Ginko Leaf Dried Ext. 160mg)

Treatment:

Drug: Cilostazol / Ginko Leaf Dried Ext.

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo