Clinical trial Recruiting at 1 site Interventional Ages 50 to 80

Daphnetin for vascular cognitive impairment without dementia

Official title: Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized, Double-blind, Placebo-controlled Study

Run by First People's Hospital of Shenyang · NCT06507488 · Data updated 2026-11-12

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

Study typeInterventional
Ages50 Years to 80 Years
SexAll
Enrollment206 (estimated)
SponsorFirst People's Hospital of Shenyang
Academic / other
Locations1 site (Shenyang, Liaoning)
StatusRecruiting
StartedJuly 7, 2025
Main results expectedJuly 7, 2025
Study endsJuly 7, 2027
Registry record updatedAugust 21, 2026
Trial IDNCT06507488 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.