Type 2 Diabets MellitusPhase 3NCT06989697
Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes
A Phase 3 study testing Cilostazol / Ginko Leaf Dried Ext. in people with Type 2 Diabets Mellitus and Cognitive Ability, General, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type 2 Diabets Mellitus, Cognitive Ability, General
- What is being tested?
- Cilostazol / Ginko Leaf Dried Ext.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Minji Sohn Dr, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
About this study
Official title: Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes
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.
- Being tested
- Cilostazol / Ginko Leaf Dried Ext., Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol / Ginko Leaf Dried Ext.Drug
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.
PlaceboDrug
Patients will receive a placebo identical in taste, aroma, and formulation to the active treatment, administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol & Ginko Leaf Dried Ext. | Experimental | Renexin CR tab (cilostazol 200mg / Ginko Leaf Dried Ext. 160mg) Receives: Drug: Cilostazol / Ginko Leaf Dried Ext. |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-Mental State Examination (MMSE) Score From Baseline to 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.
Measured: 6 months
Secondary outcomes (4)
Change in Korean Dementia Screening Questionnaire (KDSQ) Score From Baseline to 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.
Measured: 6 months
Change in Korean Version of the Montreal Cognitive Assessment (K-MoCA) Score From Baseline to 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.
Measured: 6 months
Change in Global Deterioration Scale (GDS) Stage From Baseline to 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.
Measured: 6 months
Change in Short Form-36 Health Survey (SF-36) Scores From Baseline to 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.
Measured: 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabets MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989697
- Sponsor's protocol ID
- B-2402-880-001
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cilostazol and Ginkgo Leaf Extract on Cognitive Function in Elderly Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06989697
- Acronym / sponsor ID
- B-2402-880-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol & Ginko Leaf Dried Ext. | Experimental | Drug: Cilostazol / Ginko Leaf Dried Ext.Renexin CR tab (cilostazol 200mg / Ginko Leaf Dried Ext. 160mg) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cilostazol & Ginko Leaf Dried Ext. |
| PlaceboPatients will receive a placebo identical in taste, aroma, and formulation to the active treatment, administered orally once daily. | Drug | Placebo |
Primary outcome
Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months
Time frame: 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.
4 secondary outcomes
Change in Korean Dementia Screening Questionnaire (KDSQ) Score From Baseline to 6 Months
Time frame: 6 months
Change in Korean Version of the Montreal Cognitive Assessment (K-MoCA) Score From Baseline to 6 Months
Time frame: 6 months
Change in Global Deterioration Scale (GDS) Stage From Baseline to 6 Months
Time frame: 6 months
Change in Short Form-36 Health Survey (SF-36) Scores From Baseline to 6 Months
Time frame: 3, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minji Sohn Dr, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cilostazol / Ginko Leaf Dried Ext. in people with Type 2 Diabets Mellitus and Cognitive Ability, General, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo Lim Dr., MD PhD (+82-31-787-7035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mini-Mental State Examination (MMSE) Score From Baseline to 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.