Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID06507488

Daphnetin Capsule in Treating Vascular Cognitive Impairment Without Dementia A Randomized, Double-blind, Placebo-controlled Study

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

Researchers are evaluating the clinical efficacy and safety of Daphnetin Capsules in patients with vascular cognitive impairment without dementia (VCI-ND). This condition results from strokes and other cerebrovascular diseases, causing problems with memory and thinking. The study aims to explore whether Daphnetin, which has neurovascular protective effects, can improve cognitive status, as there is currently a lack of high-quality evidence for its use in this condition. Participants will be randomly assigned to take either oral Daphnetin Capsules or a placebo three times a day for six months. This is a double-blind, placebo-controlled study following the international FINESSE framework. Follow-up visits and case report form completions will occur every three months during the study period. During the trial, participants will undergo various cognitive and functional assessments, including the Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) at six months as the primary outcome. Secondary measures include stroke incidence, dementia onset, mental state evaluations, daily living activities, motor function, and quality of life questionnaires. The study will monitor safety and efficacy throughout the six-month treatment and follow-up periods, with total participation lasting six months.

CONDITIONS

Brief 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 cognitive problems lasting at least 3 months
  • Have cognitive scores showing impairment but not dementia (MoCA score between 18 and less than 26, CDR score 0.5 or higher in at least one domain, overall CDR score of 1 or less)
  • Voluntarily agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed dementia or vascular cognitive impairment caused by diseases other than dementia
  • Stroke within the past 6 months
  • Hereditary or inflammatory small vessel disease
  • Severe neurological or psychiatric disorders, including congenital mental retardation
  • Illiteracy or severe sensory impairments that prevent neuropsychological evaluation
  • Significant depression or other serious mental illnesses
  • Severe heart, lung, kidney, or liver failure
  • Alcohol or drug addiction or use of medications affecting cognition
  • Diagnosed malignant tumors or vital organ failure
  • Bleeding problems after surgery
  • Pregnant or breastfeeding women
  • Severe high blood pressure (SBP ≥160 mmHg or DBP ≥110 mmHg)
  • Allergy or intolerance to Reserpine
  • Lack of a stable caregiver to assist participation
  • Participation in other interventional clinical trials within the last 3 months or currently enrolled in other interventional trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 6 months

Participants take oral Daphnetin Capsules or placebo three times daily for up to six months to evaluate the effect on vascular cognitive impairment.

Visits every three months during treatment

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

M

Mingming Dong, MD

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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Published Research Related To This Trial

Up-regulation of Nrf2/HO-1 and inhibition of TGF-β1/Smad2/3 signaling axis by daphnetin alleviates transverse aortic constriction-induced cardiac remodeling in mice.

Abu Mohammad Syed, Sourav Kundu, Chetan Ram...

https://pubmed.ncbi.nlm.nih.gov/35513128

Daphnetin Preconditioning Decreases Cardiac Injury and Susceptibility to Ventricular Arrhythmia following Ischaemia-Reperfusion through the TLR4/MyD88/NF-Κb Signalling Pathway.

Fan Yang, Xiaobo Jiang, Hongyi Cao...

https://pubmed.ncbi.nlm.nih.gov/33902056