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NCT Number: NCT06989697

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

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.

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Key information

Conditions

Type 2 Diabets Mellitus Cognitive Ability, General

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 6 months

    The Korean Dementia Screening Questionnaire (KDSQ) is a caregiver- or self-administered tool used to screen for cognitive decline in older adults. It consists of 15 items, each scored from 0 to 2, for a total possible score of 0 to 30.

    Higher scores indicate greater cognitive impairment. A change in the total KDSQ score from baseline to 6 months will be assessed.

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

    Time frame: 6 months

    The K-MoCA is a cognitive screening tool used to detect mild cognitive impairment and early dementia (https://mocacognition.com/paper/). It assesses multiple domains including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation.

    Higher scores indicate better cognitive function (Score Range: 0 to 30). A change in the total K-MoCA score from baseline to 6 months will be assessed.

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

    Time frame: 6 months

    The GDS is a clinical tool used to assess the severity of cognitive decline, particularly in Alzheimer's disease and other dementias. It includes 7 stages, ranging from:

    Stage 1: No cognitive decline ~ Stage 7: Very severe cognitive decline. Higher scores indicate more severe cognitive impairment. A change in the GDS stage from baseline to 6 months will be recorded based on clinical assessment.

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

    Time frame: 3, 6 months

    The SF-36 Health Survey is a 36-item, patient-reported questionnaire that assesses health-related quality of life across 8 domains:

    Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue (Vitality), Emotional Wellbeing (Mental Health), Social Functioning, Pain (Bodily Pain), General Health Perceptions.

    Each domain is scored separately on a scale from 0 to 100, with higher scores indicating better health status. Summary scores, such as the Physical Component Summary (PCS) and Mental Component Summary (MCS), may also be calculated.

    Changes in domain and/or summary scores from baseline to 6 months will be assessed.

Other outcomes

  1. Glucose regulation

    Time frame: 3, 6 months

    Change in HbA1c level From Baseline to 6 Months

  2. Lipid Panel

    Time frame: 3, 6 months

    Change in Lipid Profile From Baseline to 6 Months

  3. Renal Function

    Time frame: 3, 6 months

    Change in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) from baseline to 6 Months

  4. Liver Function

    Time frame: 3, 6 months

    Change in Liver Function (AST, ALT) From Baseline to 6 Months

  5. C-Reactive Protein

    Time frame: 6 months

    Change in hsCRP Levels From Baseline to 6 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Minji Sohn Dr, PhD

CONTACT

[email protected]

Soo Lim Dr., MD PhD

CONTACT

[email protected]

+82-31-787-7035

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • SK Chemicals Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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