Status:
RECRUITING
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
Lead Sponsor:
First People's Hospital of Shenyang
Collaborating Sponsors:
The Fourth People's Hospital of Shenyang
Conditions:
Cerebrovascular Disorders
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief 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 ...
Detailed Description
Vascular cognitive impairment (VCI) is caused by ischemic or hemorrhagic strokes and other cerebrovascular diseases, leading to cognitive and memory function impairment. With the aging population and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06507488
Start Date
July 7 2025
End Date
April 30 2026
Last Update
August 28 2025
Active Locations (1)
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1
Shenyang First People's Hospital
Shenyang, Liaoning, China, 110041