Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

NCT ID: NCT06989697

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabets Mellitus Cognitive Ability, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cilostazol & Ginko Leaf Dried Ext.

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

Group Type EXPERIMENTAL

Cilostazol / Ginko Leaf Dried Ext.

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Clinical Professor and Principal Investigator, Division of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Lim Dr., MD PhD

Role: CONTACT

+82-31-787-7035

Minji Sohn Dr, PhD

Role: CONTACT

Other Identifiers

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B-2402-880-001

Identifier Type: -

Identifier Source: org_study_id

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