Clinical trial NCT06989697: Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes
Official title: Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabets Mellitus
Cognitive Ability, General
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
First posted: 2025-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Change in Korean Dementia Screening Questionnaire (KDSQ) Score From Baseline to 6 Months
timeFrame: 6 months
measure: Change in Korean Version of the Montreal Cognitive Assessment (K-MoCA) Score From Baseline to 6 Months
timeFrame: 6 months
measure: Change in Global Deterioration Scale (GDS) Stage From Baseline to 6 Months
timeFrame: 6 months
measure: Change in Short Form-36 Health Survey (SF-36) Scores From Baseline to 6 Months
timeFrame: 3, 6 months
Other outcomes:
measure: Glucose regulation
timeFrame: 3, 6 months
measure: Lipid Panel
timeFrame: 3, 6 months
measure: Renal Function
timeFrame: 3, 6 months
measure: Liver Function
timeFrame: 3, 6 months
measure: C-Reactive Protein
timeFrame: 6 months
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: