Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT06507488

Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

Led by First People's Hospital of Shenyang · Updated on 2025-08-28

206

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

Sponsors

F

First People's Hospital of Shenyang

Lead Sponsor

T

The Fourth People's Hospital of Shenyang

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 50 and 80 years old
  • Have memory or other cognitive problems lasting at least 3 months
  • Have cognitive function that is not normal but does not meet criteria for dementia
  • Have a Montreal Cognitive Assessment (MoCA) score between 18 and less than 26
  • Have a Clinical Dementia Rating (CDR) score of at least 0.5 in one domain and overall CDR score of 1 or less
  • Agree to participate voluntarily and sign informed consent
Not Eligible

You will not qualify if you...

  • Previously diagnosed dementia or vascular cognitive impairment due to causes other than dementia
  • Had an acute stroke within the last 6 months
  • Diagnosed hereditary or inflammatory small vessel disease
  • Have congenital mental retardation or severe neurological or psychiatric disorders
  • Illiteracy or severe visual/hearing problems, severe aphasia, or other conditions preventing neuropsychological evaluation
  • Depression with Hamilton Depression Scale score 17 or higher, or serious mental illness like schizophrenia, bipolar disorder, or delirium
  • Severe heart, lung, or kidney failure, or severe liver impairment
  • Alcoholism, drug addiction, or use of medications affecting cognitive assessment
  • Diagnosed malignant tumors or vital organ failure
  • Bleeding tendency after surgery
  • Pregnant or breastfeeding women
  • Severe high blood pressure (Systolic ≥160 mmHg or Diastolic ≥110 mmHg)
  • Allergy or intolerance to Reserpine ingredients
  • Lack of a stable, reliable caregiver to assist with study participation
  • Participation in other interventional clinical studies within the last 3 months or currently involved in such studies

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shenyang First People's Hospital

Shenyang, Liaoning, China, 110041

Actively Recruiting

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Research Team

Y

Yi Sui, MD PhD

CONTACT

M

Mingming Dong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia | DecenTrialz