Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Cerebrovascular Disorders

In brief

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.

Key facts

Study ID

NCT06507488

Run by

First People's Hospital of Shenyang

People needed

206

Starts

2025-07-07

Expected to finish

2026-04-30

Last updated by the study team

2025-08-28

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shenyang First People's Hospital — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.