Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes (NCT06989697) | Clinical Trial Compass
RecruitingPhase 3
Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes
South Korea80 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months