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Recruiting NCT06989697

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

Phase III Interventional Type 2 Diabets Mellitus Cognitive Ability, General

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cilostazol / Ginko Leaf Dried Ext., Placebo.
Who it may be relevant to
Registry conditions: Type 2 Diabets Mellitus, Cognitive Ability, General. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes

Overview

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 outcome measures

  • Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months [Time frame: 6 months]
Secondary outcome measures (4)
  • Change in Korean Dementia Screening Questionnaire (KDSQ) Score From Baseline to 6 Months [Time frame: 6 months]
  • Change in Korean Version of the Montreal Cognitive Assessment (K-MoCA) Score From Baseline to 6 Months [Time frame: 6 months]
  • Change in Global Deterioration Scale (GDS) Stage From Baseline to 6 Months [Time frame: 6 months]
  • Change in Short Form-36 Health Survey (SF-36) Scores From Baseline to 6 Months [Time frame: 3, 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

South Korea · 1 center
  • Seoul National University Bundang Hospital — Seongnam-si

Identifiers

NCT: NCT06989697 · B-2402-880-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗