Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes

Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes

Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes (NCT06989697) is a Phase 3 interventional studying Type 2 Diabets Mellitus and Cognitive Ability, General, sponsored by Seoul National University Bundang Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Type 2 Diabets Mellitus, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Type 2 Diabets Mellitus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Cilostazol / 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.

DRUG

Placebo

Patients will receive a placebo identical in taste, aroma, and formulation to the active treatment, administered orally once daily.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Seoul National University Bundang Hospital

Seongnam-si, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06989697), the sponsor (Seoul National University Bundang Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06989697 clinical trial studying?

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 cogn… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06989697?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06989697?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06989697. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06989697. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.