NCT06507488 Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
| NCT ID | NCT06507488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First People's Hospital of Shenyang |
| Condition | Cerebrovascular Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 206 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2025-07-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 206 participants in total. It began in 2025-07-07 with a primary completion date of 2025-07-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Be 50-80 years of age (both ends included) 2. Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months 3. 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 4. 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 5. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: 1. Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition 2. Acute stroke event within 6 months 3. Previously diagnosed hereditary or inflammatory small vessel disease 4. Presence of congenital mental retardation and severe neurological or psychiatric disorders 5. Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation 6. Associated depression (Hamilton Depression Scale score ≥ 17), or other unrelated serious mental illness (schizophrenia, bipolar disorder, or delirium) 7. 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) 8. Alcoholism, drug addiction, or ongoing use of medications that affect cognitive assessment, such as tranquilizers, sleeping pills, puberty pills, and cholinergics 9. Malignant tumors that have been clearly diagnosed, vital organ failure 10. Those with bleeding tendency after surgery 11. Pregnant and lactating women are prohibited 12. Severe hypertension (Systolic Blood Pressure(SBP)≥160mmHg and/or Diastolic Blood Pressure(DBP)≥110mmHg) is prohibited 13. Previous allergy or intolerance to the ingredients of Reserpine 14. The subject does not have a stable and reliable caregiver or the caregiver is unable to assist the subject in participating in the study 15. Patients who have participated in other interventional clinical studies within the last 3 months or are currently participating in other interventional clinical studies.
Contact & Investigator
Yi Sui, MD PhD
PRINCIPAL INVESTIGATOR
The Fourth People's Hospital of Shenyang, China Medical University
Frequently Asked Questions
Who can join the NCT06507488 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Cerebrovascular Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06507488 currently recruiting?
Yes, NCT06507488 is actively recruiting participants. Contact the research team at jakeyisui@icloud.com for enrollment information.
Where is the NCT06507488 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06507488 clinical trial?
NCT06507488 is sponsored by First People's Hospital of Shenyang. The principal investigator is Yi Sui, MD PhD at The Fourth People's Hospital of Shenyang, China Medical University. The trial plans to enroll 206 participants.