Cilostazol and Ginkgo for improving cognitive function in elderly with diabetes
Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes
PHASE3 · Seoul National University Bundang Hospital · NCT06989697
This study is testing if a combination of cilostazol and ginkgo biloba can help improve thinking and memory in older adults with type 2 diabetes.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital (other) |
| Locations | 1 site (Seongnam-si) |
| Trial ID | NCT06989697 on ClinicalTrials.gov |
What this trial studies
This exploratory pilot study evaluates the cognitive improvement effects of a combination therapy using cilostazol and ginkgo biloba extract in elderly patients diagnosed with type 2 diabetes mellitus. The study aims to determine if this combination can enhance cerebral blood flow and provide neuroprotection, potentially preventing cognitive decline. Participants will receive either the active treatment or a placebo, and their cognitive abilities will be assessed using standardized measures. The findings may lay the groundwork for future therapeutic strategies targeting cognitive impairment in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 years or older with type 2 diabetes and a Mini-Mental State Examination score between 24 and 28.
Not a fit: Patients with type 1 diabetes, severe cognitive impairment, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new preventive strategies for cognitive decline in elderly patients with type 2 diabetes.
How similar studies have performed: While the combination of cilostazol and ginkgo biloba has shown potential benefits individually, this specific combination approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seongnam-si
- Seoul National University Bundang Hospital — Seongnam-si, South Korea (RECRUITING)
Study contacts
- Study coordinator: Soo Lim Dr., MD PhD
- Email: limsoo@snu.ac.kr
- Phone: +82-31-787-7035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabets Mellitus, Cognitive Ability, General