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| Name | Class |
|---|---|
| SK Chemicals Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol & Ginko Leaf Dried Ext. | Experimental | Renexin CR tab (cilostazol 200mg / Ginko Leaf Dried Ext. 160mg) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose regulation | Change in HbA1c level From Baseline to 6 Months | 3, 6 months |
| Lipid Panel | Change in Lipid Profile From Baseline to 6 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim Dr., MD PhD | Contact | +82-31-787-7035 | limsoo@snu.ac.kr | |
| Minji Sohn Dr, PhD | Contact | rainbowmjs@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | South Korea |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Patients will receive a placebo identical in taste, aroma, and formulation to the active treatment, administered orally once daily. |
|
| 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 3, 6 months |
| 3, 6 months |
| Renal Function | Change in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) from baseline to 6 Months | 3, 6 months |
| Liver Function | Change in Liver Function (AST, ALT) From Baseline to 6 Months | 3, 6 months |
| C-Reactive Protein | Change in hsCRP Levels From Baseline to 6 Months | 6 months |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |