Daphnetin for vascular cognitive impairment without dementia
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized, Double-blind, Placebo-controlled Study
This study will test whether taking Daphnetin capsules daily for six months helps thinking and memory in adults aged 50–80 who have vascular cognitive impairment but do not have dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | First People's Hospital of Shenyang Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06507488 on ClinicalTrials.gov |
What this trial studies
Participants are assigned to receive either oral Daphnetin capsules or a matching placebo daily for six months, with follow-up visits every three months. Cognitive change is measured primarily with the Vascular Dementia Assessment Scale–cognitive subscale (VADAS‑cog) at six months, and MoCA and CDR scores are used for screening and monitoring. The trial enrolls adults aged 50–80 who report persistent cognitive complaints and meet MoCA (18–25) and CDR criteria consistent with impairment but not dementia. Safety and tolerability are recorded throughout the treatment and follow‑up period.
Who should consider this trial
Good fit: Adults aged 50–80 with persistent cognitive complaints, MoCA scores between 18 and 25, and CDR showing impairment in at least one domain but overall CDR ≤1 (no diagnosed dementia) are the intended participants.
Not a fit: People with diagnosed dementia, cognitive impairment from non‑vascular causes, those outside the 50–80 age range, or those unable to attend study visits in Shenyang are unlikely to benefit from or qualify for this trial.
Why it matters
Potential benefit: If successful, Daphnetin could improve cognitive function or slow decline in people with vascular cognitive impairment without dementia, offering a new treatment option.
How similar studies have performed: Preclinical work and small clinical reports suggest Daphnetin has neurovascular and anti‑inflammatory effects, but high‑quality randomized data in vascular cognitive impairment without dementia are lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenyang, Liaoning
- Shenyang First People's Hospital — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Yi Sui, MD PhD — The Fourth People's Hospital of Shenyang, China Medical University
- Study coordinator: Yi Sui, MD PhD
- Email: jakeyisui@icloud.com
- Phone: +86 24 86861329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.