Cognitive Ability, General, Type 2 Diabets Mellitus
Conditions
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.
Interventions
DRUGCilostazol / 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.
DRUGPlacebo
Patients will receive a placebo identical in taste, aroma, and formulation to the active treatment, administered orally once daily.
Sponsors
SK Chemicals Co., Ltd.
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Korean Dementia Screening Questionnaire (KDSQ) Score From Baseline to 6 Months | 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. |
| Change in Korean Version of the Montreal Cognitive Assessment (K-MoCA) Score From Baseline to 6 Months | 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. |
| Change in Global Deterioration Scale (GDS) Stage From Baseline to 6 Months | 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. |
| Change in Short Form-36 Health Survey (SF-36) Scores From Baseline to 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Glucose regulation | 3, 6 months | Change in HbA1c level From Baseline to 6 Months |
| Lipid Panel | 3, 6 months | Change in Lipid Profile From Baseline to 6 Months |
| Renal Function | 3, 6 months | Change in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) from baseline to 6 Months |
| Liver Function | 3, 6 months | Change in Liver Function (AST, ALT) From Baseline to 6 Months |
| C-Reactive Protein | 6 months | Change in hsCRP Levels From Baseline to 6 Months |
Countries
South Korea
Contacts
Primary ContactSoo Lim Dr., MD PhD
Backup ContactMinji Sohn Dr, PhD
Outcome results
None listed