Cerebrovascular DisordersDISCONCT06507488
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
A study testing Daphnetin Capsule in people with Cerebrovascular Disorders, run by First People's Hospital of Shenyang at 1 site in China.
Trial summary
The purpose of this clinical trial is to understand and evaluate the clinical efficacy and safety of Daphnetin Capsule in patients with vascular cognitive impairment. Changes in the Vascular Dementia Assessment Scale-cog(VADAS-cog) at 6 months were evaluated. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders
- What is being tested?
- Daphnetin Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2025to 7 Jul 2027
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 50-80 years of age (both ends included)
- Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months
- Have a cognitive level that is neither normal nor demented according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Criteria ( DSM-V criteria）, a Montreal Cognitive Assessment (MoCA scale) score <26 and ≥18, and a Clinical Dementia Rating (CDR) scale score of ≥0.5 in at least one domain and an overall CDR score ≤1
- Have a cognitive level that is neither normal nor demented according to DSM-V criteria, a MoCA scale score <26 and ≥18, and a CDR scale score of ≥0.5 in at least one domain and an overall CDR score ≤1
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition
- Acute stroke event within 6 months
- Previously diagnosed hereditary or inflammatory small vessel disease
- Presence of congenital mental retardation and severe neurological or psychiatric disorders
- Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation
- Associated depression (Hamilton Depression Scale score ≥ 17), or other unrelated serious mental illness (schizophrenia, bipolar disorder, or delirium)
Show all 15Show fewer
- Combined severe cardiac, pulmonary, and renal insufficiency (creatinine > 2.0 mg/dl or 177 μ mol/L), and severe hepatic impairment (aminotransferases more than 3 times normal)
- Alcoholism, drug addiction, or ongoing use of medications that affect cognitive assessment, such as tranquilizers, sleeping pills, puberty pills, and cholinergics
- Malignant tumors that have been clearly diagnosed, vital organ failure
- Those with bleeding tendency after surgery
- Pregnant and lactating women are prohibited
- Severe hypertension (Systolic Blood Pressure(SBP)≥160mmHg and/or Diastolic Blood Pressure(DBP)≥110mmHg) is prohibited
- Previous allergy or intolerance to the ingredients of Reserpine
- The subject does not have a stable and reliable caregiver or the caregiver is unable to assist the subject in participating in the study
- Patients who have participated in other interventional clinical studies within the last 3 months or are currently participating in other interventional clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenyang First People's Hospital
Shenyang, Liaoning, 110041
Li Li, MD PhD, +86 24 31956000, lily720823@163.com
Xinze Guo, MD, +86 24 31956000, 176953982@qq.com
About this study
Official title: Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized, Double-blind, Placebo-controlled Study
The purpose of this clinical trial is to understand and evaluate the clinical efficacy and safety of Daphnetin Capsule in patients with vascular cognitive impairment. Changes in the Vascular Dementia Assessment Scale-cog(VADAS-cog) at 6 months were evaluated. Although Daphnetin has a dual neurovascular protective effect, however, there is still a lack of relevant high-quality studies on its role in patients with vascular cognitive impairment, especially in patients with vascular cognitive impairment in non-dementia (VCI-ND), whether it has a role in improving cognitive status needs to be urgently explored in high-quality clinical studies. Researchers are comparing Daphnetin to placebo (a drug-free analog) to see if Daphnetin is effective in treating vascular cognitive impairment. Participants will take either Daphnetin or placebo daily for six months, with follow-up visits every three months and completion of a case report form.
Read the detailed description
Vascular cognitive impairment (VCI) is caused by ischemic or hemorrhagic strokes and other cerebrovascular diseases, leading to cognitive and memory function impairment. With the aging population and high incidence of cerebrovascular diseases in China, Vascular cognitive impairment (VCI) prevalence is rising, increasing the disease burden. However, due to the complexity of Vascular cognitive impairment (VCI) symptoms and imaging changes, targeted therapies are currently lacking.
Daphnetin, a coumarin derivative, has shown promise in treating various diseases and has gained significant attention recently. It offers "triple protection" for blood, blood vessels, and ischemic tissues by inhibiting inflammation, anticoagulation, and thrombosis, protecting endothelial structures, and regulating vasoactive substances. Daphnetin is particularly beneficial for cardio-cerebral vascular disease, diabetes mellitus, and microvascular complications. It also expands peripheral blood vessels, improving circulation and alleviating vascular occlusive diseases.
Research indicates that Daphnetin's anti-inflammatory effects can inhibit neuroinflammation, promote synaptic growth, and enhance neuronal survival, protecting nerve cells and repairing damage. Despite these benefits, there is a lack of high-quality studies on Daphnetin's role in non-dementia vascular cognitive impairment (VCI-ND).
This project aims to evaluate the clinical efficacy and safety of oral Daphnetin capsules in treating Vascular cognitive impairment (VCI) through a prospective, randomized, double-blind, placebo-controlled study. Patients with vascular cognitive dysfunction confirmed by cerebral small vessel disease imaging will participate. The study will follow the international FINESSE framework, comparing Daphnetin to a placebo over six months, with follow-up visits and case report forms completed every three months.
- Conditions
- Cerebrovascular Disorders
- Being tested
- Daphnetin Capsule, Placebo
- Keywords
- Vascular Cognitive Impairment No Dementia, Daphnetin, Effectiveness, safety
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daphnetin CapsuleDrug
Also called 7,8-dihydroxycoumarin
Daphnetin, chemically known as 7,8-dihydroxycoumarin, also known as ZuShiMaJiaSu, is a class of coumarin derivatives derived from different Daphnetin genus plant .
PlaceboDrug
The placebo is a Daphnetin Capsule simulants
| Study group | Role | What they receive |
|---|---|---|
| Daphnetin | Experimental | oral Daphnetin Capsule three capsules/tid for up to six months. Receives: Drug: Daphnetin Capsule |
| Placebo | Placebo comparator | oral Placebo (Daphnetin Capsule simulants) three capsules/tid for up to six months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)
Vascular Dementia Assessment Scale-cognitive subscale（VADAS-cog） is a revision of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) to be a better measure in vascular conditions，The lowest score is 0, with higher scores representing higher levels of cognitive dysfunction and poorer status of the patient.
Measured: 6 months
Secondary outcomes (11)
Incidence of combined endpoints: including new stroke (ischemic Trial of ORG 10172 in Acute Stroke Treatment typing [TOAST typing] or hemorrhagic)/transient ischemic attack, myocardial infarction, new-onset dementia, death
For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis.
Measured: 6 months
Incidence of each individual event of the combined endpoint
For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis.
Measured: 6 months
Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change
Consists of three parts The clinician's impression of change is an assessment of change from baseline, not an assessment of severity. The clinician may refer to his/her own baseline information compiled in Part I when making the assessment of change. The clinician's assessment of impression of change should then be replicated in the main study case report form.The score of CIBIC-plus ranges from 1 to 7, and the score of 1-3 indicates improvement, 4 means no changed, and 5-7 indicates worse.
Measured: 6 months
Change in the Brief Mental State Evaluation Scale (MMSE)
Each correct item is scored as 1 point, and errors are scored as 0 points. The total score ranges from 0 to 30, and the cut-off value for normal and abnormal is related to the level of education; ≤17 points for the illiterate (no education) group, ≤20 points for the elementary school (≤6 years of education) group, and ≤24 points for the secondary school or above (>6 years of education) group. Cognitive deficits are considered to be below the cut-off value and normal above it.
Measured: 6 months
Change in the Montreal Cognitive Assessment Scale (MoCA)
The MoCA scale is a 30-point scale, with ≥26 normal, 18-26 mild cognitive impairment (MCI), 10-17 moderate, and less than 10 severe.Patients with MCI scored approximately 22 (19-25) points, and patients with AD scored between 11-21 points.
Measured: 6 months
Changes in the Symbol Digit Transformation Test (SDMT)
Completion of the SDMT scale within 90 seconds, with a total score of 0-110; the lower the score, the more severe the degree of cognitive impairment
Measured: 6 months
Change in Clinical Dementia Rating Scale (CDR)
The total score ranges from 0 to 18,The higher the score, the more demented the patient is, the worse the state is.
Measured: 6 months
Change in Neuropsychiatric Questionnaire (NPI-Q)
Presence of symptoms (1-2): 1=present 2=absent. Frequency (1-4 points): 1=occasional, less than weekly; 2=frequent, about weekly; 3=several times a week but less than daily; 4=very frequent, once or more at a time or continuously.
Severity (on a scale of 1 to 3): 1=mild, perceptible but not obvious; 2=moderate, obvious but not very prominent; 3=severe, very prominent changes.
The degree of distress caused by the symptom to the caregiver (0-5 points): 0 = no distress; 1 = very mild distress, caregiver does not need to take steps to cope; 2 = mild distress, caregiver copes easily; 3 = moderate distress, caregiver struggles to cope; 4 = severe, caregiver is barely able to cope; 5 = extreme distress, caregiver is unable to cope. The higher the score the more severe
Measured: 6 months
Changes in the Activities of Daily Living Scale (ADL)
1 = can do it all by myself; 2 = can still do it with some difficulty; 3 = need help 4 = cannot do it at all. When the patient never does it but is able to do it, it is rated as 1, never does it but has difficulty doing it but does not need help, 2, never does it but needs help, 3, never does it and is unable to do it, 4. The range of scores is from 20 to 80, and a score of >23 is considered to be cognitively impaired.
Measured: 6 months
Changes in motor function (TUG, time to walk three meters)
Change in motor score (TUG, time to walk three meters) at 6 months relative to baseline
Measured: 6 months
EuroQol Five Dimensions Questionnaire (EQ-5D)
The EuroQol Five Dimensions Questionnaire (EQ-5D) health description system consists of five dimensions: mobility (MO), self-care (SC), ability to perform activities of daily living (UA), pain or discomfort (PD), and anxiety or depression (AD), each of which can be reported separately as "no problem, moderate problem, or severe problem".Self-rated health on a scale of 0 to 100, the higher the score the better your health is considered to be.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start7 Jul 2025
- Primary completion7 Jul 2025
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Shenyang
- Sponsor type
- University, hospital or other
- Collaborators
- Fourth People's Hospital of Shenyang
- Responsible party
- Principal investigator, Dr. Yi Sui, Fourth People's Hospital of Shenyang
- Investigators
- Yi Sui, MD PhD, Principal investigator, The Fourth People's Hospital of Shenyang, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507488
- Sponsor's protocol ID
- RXSJNJLXD-2024-SYSY
- Acronym
- DISCO
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Benisty S. [Current concepts in vascular dementia]. Geriatr Psychol Neuropsychiatr Vieil. 2013 Jun;11(2):171-80. doi: 10.1684/pnv.2013.0410. French.
PubMed 23803634Wu YT, Lee HY, Norton S, Chen C, Chen H, He C, Fleming J, Matthews FE, Brayne C. Prevalence studies of dementia in mainland china, Hong Kong and taiwan: a systematic review and meta-analysis. PLoS One. 2013 Jun 11;8(6):e66252. doi: 10.1371/journal.pone.0066252. Print 2013.
PubMed 23776645D'Onofrio G, Sancarlo D, Addante F, Ciccone F, Cascavilla L, Paris F, Picoco M, Nuzzaci C, Elia AC, Greco A, Chiarini R, Panza F, Pilotto A. Caregiver burden characterization in patients with Alzheimer's disease or vascular dementia. Int J Geriatr Psychiatry. 2015 Sep;30(9):891-9. doi: 10.1002/gps.4232. Epub 2014 Dec 4.
PubMed 25475248Kalaria RN. The pathology and pathophysiology of vascular dementia. Neuropharmacology. 2018 May 15;134(Pt B):226-239. doi: 10.1016/j.neuropharm.2017.12.030. Epub 2017 Dec 19.
PubMed 29273521Plassman BL, Langa KM, Fisher GG, Heeringa SG, Weir DR, Ofstedal MB, Burke JR, Hurd MD, Potter GG, Rodgers WL, Steffens DC, Willis RJ, Wallace RB. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology. 2007;29(1-2):125-32. doi: 10.1159/000109998. Epub 2007 Oct 29.
PubMed 17975326Javed M, Saleem A, Xaveria A, Akhtar MF. Daphnetin: A bioactive natural coumarin with diverse therapeutic potentials. Front Pharmacol. 2022 Sep 29;13:993562. doi: 10.3389/fphar.2022.993562. eCollection 2022.
PubMed 36249766Singh L, Singh AP, Bhatti R. Mechanistic interplay of various mediators involved in mediating the neuroprotective effect of daphnetin. Pharmacol Rep. 2021 Oct;73(5):1220-1229. doi: 10.1007/s43440-021-00261-z. Epub 2021 Apr 16.
PubMed 33860917Chaudhary PK, Kim S, Kim S. Antiplatelet Effect of Daphnetin Is Regulated by cPLA2-Mediated Thromboxane A2 Generation in Mice. Int J Mol Sci. 2023 Mar 17;24(6):5779. doi: 10.3390/ijms24065779.
PubMed 36982853Syed AM, Kundu S, Ram C, Kulhari U, Kumar A, Mugale MN, Mohapatra P, Murty US, Sahu BD. Up-regulation of Nrf2/HO-1 and inhibition of TGF-beta1/Smad2/3 signaling axis by daphnetin alleviates transverse aortic constriction-induced cardiac remodeling in mice. Free Radic Biol Med. 2022 Jun;186:17-30. doi: 10.1016/j.freeradbiomed.2022.04.019. Epub 2022 May 2.
PubMed 35513128Yang F, Jiang X, Cao H, Shuai W, Zhang L, Wang G, Quan D, Jiang X. Daphnetin Preconditioning Decreases Cardiac Injury and Susceptibility to Ventricular Arrhythmia following Ischaemia-Reperfusion through the TLR4/MyD88/NF-Kappab Signalling Pathway. Pharmacology. 2021;106(7-8):369-383. doi: 10.1159/000513631. Epub 2021 Apr 26.
PubMed 33902056Yang Y, Sheng Q, Nie Z, Liu L, Zhang W, Chen G, Ye F, Shi L, Lv Z, Xie J, Wang D. Daphnetin inhibits spinal glial activation via Nrf2/HO-1/NF-kappaB signaling pathway and attenuates CFA-induced inflammatory pain. Int Immunopharmacol. 2021 Sep;98:107882. doi: 10.1016/j.intimp.2021.107882. Epub 2021 Jun 26.
PubMed 34182245Du G, Tu H, Li X, Pei A, Chen J, Miao Z, Li J, Wang C, Xie H, Xu X, Zhao H. Daphnetin, a natural coumarin derivative, provides the neuroprotection against glutamate-induced toxicity in HT22 cells and ischemic brain injury. Neurochem Res. 2014 Feb;39(2):269-75. doi: 10.1007/s11064-013-1218-6. Epub 2013 Dec 17.
PubMed 24343531Yu W, Wang H, Ying H, Yu Y, Chen D, Ge W, Shi L. Daphnetin attenuates microglial activation and proinflammatory factor production via multiple signaling pathways. Int Immunopharmacol. 2014 Jul;21(1):1-9. doi: 10.1016/j.intimp.2014.04.005. Epub 2014 Apr 18.
PubMed 24747094Zhi J, Duan B, Pei J, Wu S, Wei J. Daphnetin protects hippocampal neurons from oxygen-glucose deprivation-induced injury. J Cell Biochem. 2019 Mar;120(3):4132-4139. doi: 10.1002/jcb.27698. Epub 2018 Sep 27.
PubMed 30260007Wang D, Zhu B, Liu X, Han Q, Ge W, Zhang W, Lu Y, Wu Q, Shi L. Daphnetin Ameliorates Experimental Autoimmune Encephalomyelitis Through Regulating Heme Oxygenase-1. Neurochem Res. 2020 Apr;45(4):872-881. doi: 10.1007/s11064-020-02960-0. Epub 2020 Jan 16.
PubMed 31950453
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06507488
- Acronym / sponsor ID
- DISCO / RXSJNJLXD-2024-SYSY
- Conditions
- Cerebrovascular Disorders
- Keywords
- Vascular Cognitive Impairment No Dementia, Daphnetin, Effectiveness, safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- First People's Hospital of ShenyangUniversity, hospital or other
- Collaborators
- Fourth People's Hospital of Shenyang
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 18 Jul 2024 (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.
The purpose of this clinical trial is to understand and evaluate the clinical efficacy and safety of Daphnetin Capsule in patients with vascular cognitive impairment. Changes in the Vascular Dementia Assessment Scale-cog(VADAS-cog) at 6 months were evaluated. Although Daphnetin has a dual neurovascular protective effect, however, there is still a lack of relevant high-quality studies on its role in patients with vascular cognitive impairment, especially in patients with vascular cognitive impairment in non-dementia (VCI-ND), whether it has a role in improving cognitive status needs to be urgently explored in high-quality clinical studies. Researchers are comparing Daphnetin to placebo (a drug-free analog) to see if Daphnetin is effective in treating vascular cognitive impairment. Participants will take either Daphnetin or placebo daily for six months, with follow-up visits every three months and completion of a case report form.
Detailed description
Vascular cognitive impairment (VCI) is caused by ischemic or hemorrhagic strokes and other cerebrovascular diseases, leading to cognitive and memory function impairment. With the aging population and high incidence of cerebrovascular diseases in China, Vascular cognitive impairment (VCI) prevalence is rising, increasing the disease burden. However, due to the complexity of Vascular cognitive impairment (VCI) symptoms and imaging changes, targeted therapies are currently lacking.
Daphnetin, a coumarin derivative, has shown promise in treating various diseases and has gained significant attention recently. It offers "triple protection" for blood, blood vessels, and ischemic tissues by inhibiting inflammation, anticoagulation, and thrombosis, protecting endothelial structures, and regulating vasoactive substances. Daphnetin is particularly beneficial for cardio-cerebral vascular disease, diabetes mellitus, and microvascular complications. It also expands peripheral blood vessels, improving circulation and alleviating vascular occlusive diseases.
Research indicates that Daphnetin's anti-inflammatory effects can inhibit neuroinflammation, promote synaptic growth, and enhance neuronal survival, protecting nerve cells and repairing damage. Despite these benefits, there is a lack of high-quality studies on Daphnetin's role in non-dementia vascular cognitive impairment (VCI-ND).
This project aims to evaluate the clinical efficacy and safety of oral Daphnetin capsules in treating Vascular cognitive impairment (VCI) through a prospective, randomized, double-blind, placebo-controlled study. Patients with vascular cognitive dysfunction confirmed by cerebral small vessel disease imaging will participate. The study will follow the international FINESSE framework, comparing Daphnetin to a placebo over six months, with follow-up visits and case report forms completed every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daphnetin | Experimental | Drug: Daphnetin Capsuleoral Daphnetin Capsule three capsules/tid for up to six months. |
| Placebo | Placebo comparator | Drug: Placebooral Placebo (Daphnetin Capsule simulants) three capsules/tid for up to six months. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 50-80 years of age (both ends included)
- Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months
- Have a cognitive level that is neither normal nor demented according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Criteria ( DSM-V criteria）, a Montreal Cognitive Assessment (MoCA scale) score <26 and ≥18, and a Clinical Dementia Rating (CDR) scale score of ≥0.5 in at least one domain and an overall CDR score ≤1
- Have a cognitive level that is neither normal nor demented according to DSM-V criteria, a MoCA scale score <26 and ≥18, and a CDR scale score of ≥0.5 in at least one domain and an overall CDR score ≤1
- Voluntarily participate in this study and sign an informed consent form.
Key exclusion criteria (15 listed)
- Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition
- Acute stroke event within 6 months
- Previously diagnosed hereditary or inflammatory small vessel disease
- Presence of congenital mental retardation and severe neurological or psychiatric disorders
- Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation
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 |
|---|---|---|
| Daphnetin CapsuleAlso: 7,8-dihydroxycoumarinDaphnetin, chemically known as 7,8-dihydroxycoumarin, also known as ZuShiMaJiaSu, is a class of coumarin derivatives derived from different Daphnetin genus plant . | Drug | Daphnetin |
| PlaceboThe placebo is a Daphnetin Capsule simulants | Drug | Placebo |
Primary outcome
Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)
Time frame: 6 months
Vascular Dementia Assessment Scale-cognitive subscale（VADAS-cog） is a revision of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) to be a better measure in vascular conditions，The lowest score is 0, with higher scores representing higher levels of cognitive dysfunction and poorer status of the patient.
11 secondary outcomes
Incidence of combined endpoints: including new stroke (ischemic Trial of ORG 10172 in Acute Stroke Treatment typing [TOAST typing] or hemorrhagic)/transient ischemic attack, myocardial infarction, new-onset dementia, death
Time frame: 6 months
Incidence of each individual event of the combined endpoint
Time frame: 6 months
Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change
Time frame: 6 months
Change in the Brief Mental State Evaluation Scale (MMSE)
Time frame: 6 months
Change in the Montreal Cognitive Assessment Scale (MoCA)
Time frame: 6 months
Changes in the Symbol Digit Transformation Test (SDMT)
Time frame: 6 months
Change in Clinical Dementia Rating Scale (CDR)
Time frame: 6 months
Change in Neuropsychiatric Questionnaire (NPI-Q)
Time frame: 6 months
Changes in the Activities of Daily Living Scale (ADL)
Time frame: 6 months
Changes in motor function (TUG, time to walk three meters)
Time frame: 6 months
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: 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 21 Aug 2026.
- Background: PubMed 23803634Benisty S. [Current concepts in vascular dementia]. Geriatr Psychol Neuropsychiatr Vieil. 2013 Jun;11(2):171-80. doi: 10.1684/pnv.2013.0410. French.
- Background: PubMed 23776645Wu YT, Lee HY, Norton S, Chen C, Chen H, He C, Fleming J, Matthews FE, Brayne C. Prevalence studies of dementia in mainland china, Hong Kong and taiwan: a systematic review and meta-analysis. PLoS One. 2013 Jun 11;8(6):e66252. doi: 10.1371/journal.pone.0066252. Print 2013.
- Background: PubMed 25475248D'Onofrio G, Sancarlo D, Addante F, Ciccone F, Cascavilla L, Paris F, Picoco M, Nuzzaci C, Elia AC, Greco A, Chiarini R, Panza F, Pilotto A. Caregiver burden characterization in patients with Alzheimer's disease or vascular dementia. Int J Geriatr Psychiatry. 2015 Sep;30(9):891-9. doi: 10.1002/gps.4232. Epub 2014 Dec 4.
- Background: PubMed 29273521Kalaria RN. The pathology and pathophysiology of vascular dementia. Neuropharmacology. 2018 May 15;134(Pt B):226-239. doi: 10.1016/j.neuropharm.2017.12.030. Epub 2017 Dec 19.
- Background: PubMed 17975326Plassman BL, Langa KM, Fisher GG, Heeringa SG, Weir DR, Ofstedal MB, Burke JR, Hurd MD, Potter GG, Rodgers WL, Steffens DC, Willis RJ, Wallace RB. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology. 2007;29(1-2):125-32. doi: 10.1159/000109998. Epub 2007 Oct 29.
- Background: PubMed 36249766Javed M, Saleem A, Xaveria A, Akhtar MF. Daphnetin: A bioactive natural coumarin with diverse therapeutic potentials. Front Pharmacol. 2022 Sep 29;13:993562. doi: 10.3389/fphar.2022.993562. eCollection 2022.
- Background: PubMed 33860917Singh L, Singh AP, Bhatti R. Mechanistic interplay of various mediators involved in mediating the neuroprotective effect of daphnetin. Pharmacol Rep. 2021 Oct;73(5):1220-1229. doi: 10.1007/s43440-021-00261-z. Epub 2021 Apr 16.
- Background: PubMed 36982853Chaudhary PK, Kim S, Kim S. Antiplatelet Effect of Daphnetin Is Regulated by cPLA2-Mediated Thromboxane A2 Generation in Mice. Int J Mol Sci. 2023 Mar 17;24(6):5779. doi: 10.3390/ijms24065779.
- Background: PubMed 35513128Syed AM, Kundu S, Ram C, Kulhari U, Kumar A, Mugale MN, Mohapatra P, Murty US, Sahu BD. Up-regulation of Nrf2/HO-1 and inhibition of TGF-beta1/Smad2/3 signaling axis by daphnetin alleviates transverse aortic constriction-induced cardiac remodeling in mice. Free Radic Biol Med. 2022 Jun;186:17-30. doi: 10.1016/j.freeradbiomed.2022.04.019. Epub 2022 May 2.
- Background: PubMed 33902056Yang F, Jiang X, Cao H, Shuai W, Zhang L, Wang G, Quan D, Jiang X. Daphnetin Preconditioning Decreases Cardiac Injury and Susceptibility to Ventricular Arrhythmia following Ischaemia-Reperfusion through the TLR4/MyD88/NF-Kappab Signalling Pathway. Pharmacology. 2021;106(7-8):369-383. doi: 10.1159/000513631. Epub 2021 Apr 26.
- Background: PubMed 34182245Yang Y, Sheng Q, Nie Z, Liu L, Zhang W, Chen G, Ye F, Shi L, Lv Z, Xie J, Wang D. Daphnetin inhibits spinal glial activation via Nrf2/HO-1/NF-kappaB signaling pathway and attenuates CFA-induced inflammatory pain. Int Immunopharmacol. 2021 Sep;98:107882. doi: 10.1016/j.intimp.2021.107882. Epub 2021 Jun 26.
- Background: PubMed 24343531Du G, Tu H, Li X, Pei A, Chen J, Miao Z, Li J, Wang C, Xie H, Xu X, Zhao H. Daphnetin, a natural coumarin derivative, provides the neuroprotection against glutamate-induced toxicity in HT22 cells and ischemic brain injury. Neurochem Res. 2014 Feb;39(2):269-75. doi: 10.1007/s11064-013-1218-6. Epub 2013 Dec 17.
- Individual participant dataSharing planned: Yes
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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.
Yi Sui, MD PhD principal investigator
The Fourth People's Hospital of Shenyang, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daphnetin Capsule in people with Cerebrovascular Disorders, run by First People's Hospital of Shenyang at 1 site in China.
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 5 inclusion and 15 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 21 Aug 2026. 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 China. 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.
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 Yi Sui, MD PhD (+86 24 86861329, jakeyisui@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06507488, which also lists 24 linked publications.
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 21 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.