Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

NCT06989697 | Recruiting Phase 3 DMC

• 1 other identifier: B-2402-880-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabets Mellitus; Cognitive Ability, General

Outcome Measures

Primary Outcomes (1)

• Change in Mini-Mental State Examination (MMSE) Score From Baseline to 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.

  6 months

Secondary Outcomes (4)

• Change in Korean Dementia Screening Questionnaire (KDSQ) Score From Baseline to 6 Months

  6 months

• Change in Korean Version of the Montreal Cognitive Assessment (K-MoCA) Score From Baseline to 6 Months

  6 months

• Change in Global Deterioration Scale (GDS) Stage From Baseline to 6 Months

  6 months

• Change in Short Form-36 Health Survey (SF-36) Scores From Baseline to 6 Months

  3, 6 months

Other Outcomes (5)

• Glucose regulation

  3, 6 months

• Lipid Panel

  3, 6 months

• Renal Function

  3, 6 months

Study Arms (2)

Cilostazol & Ginko Leaf Dried Ext.

EXPERIMENTAL

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

Drug: Cilostazol / Ginko Leaf Dried Ext.

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cilostazol / Ginko Leaf Dried Ext. 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.

Cilostazol & Ginko Leaf Dried Ext.

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• SK Chemicals Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

RECRUITING

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Soo Lim Dr., MD PhD

CONTACT

+82-31-787-7035; limsoo@snu.ac.kr

Minji Sohn Dr, PhD

CONTACT

rainbowmjs@naver.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Principal Investigator, Division of Endocrinology

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 25, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

KR (1)