Health TrialsbyHealthPanel

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

ConditionsType 2 Diabets MellitusCognitive Ability, General
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cilostazol & Ginko Leaf Dried Ext.Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

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

Time frame
6 months
3

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

Time frame
6 months
4

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

Time frame
3, 6 months

Other outcomes

1

Glucose regulation

Change in HbA1c level From Baseline to 6 Months

Time frame
3, 6 months
2

Lipid Panel

Change in Lipid Profile From Baseline to 6 Months

Time frame
3, 6 months
3

Renal Function

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

Time frame
3, 6 months
4

Liver Function

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

Time frame
3, 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

SK Chemicals Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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