RecruitingNot ApplicableNCT06507488

Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

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

Sponsor

First People's Hospital of Shenyang

Enrollment

206 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Cerebrovascular Disorders

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

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria5

Be 50-80 years of age (both ends included)
Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months
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
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
Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria15

Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition
Acute stroke event within 6 months
Previously diagnosed hereditary or inflammatory small vessel disease
Presence of congenital mental retardation and severe neurological or psychiatric disorders
Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation
Associated depression (Hamilton Depression Scale score ≥ 17), or other unrelated serious mental illness (schizophrenia, bipolar disorder, or delirium)
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)
Alcoholism, drug addiction, or ongoing use of medications that affect cognitive assessment, such as tranquilizers, sleeping pills, puberty pills, and cholinergics
Malignant tumors that have been clearly diagnosed, vital organ failure
Those with bleeding tendency after surgery
Pregnant and lactating women are prohibited
Severe hypertension (Systolic Blood Pressure(SBP)≥160mmHg and/or Diastolic Blood Pressure(DBP)≥110mmHg) is prohibited
Previous allergy or intolerance to the ingredients of Reserpine
The subject does not have a stable and reliable caregiver or the caregiver is unable to assist the subject in participating in the study
Patients who have participated in other interventional clinical studies within the last 3 months or are currently participating in other interventional clinical studies.

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Interventions

DRUGDaphnetin Capsule

Daphnetin, chemically known as 7,8-dihydroxycoumarin, also known as ZuShiMaJiaSu, is a class of coumarin derivatives derived from different Daphnetin genus plant .

DRUGPlacebo

The placebo is a Daphnetin Capsule simulants