Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia (NCT06507488) | Clinical Trial Compass
RecruitingNot Applicable
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
China206 participantsStarted 2025-07-07
Plain-language 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.
Who can participate
Age range50 Years β 80 Years
SexALL
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Inclusion criteria
β. Be 50-80 years of age (both ends included)
β. Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months
β. Have a cognitive level that is neither normal nor demented according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Criteria ( DSM-V criteriaοΌ, a Montreal Cognitive Assessment (MoCA scale) score \<26 and β₯18, and a Clinical Dementia Rating (CDR) scale score of β₯0.5 in at least one domain and an overall CDR score β€1
β. Have a cognitive level that is neither normal nor demented according to DSM-V criteria, a MoCA scale score \<26 and β₯18, and a CDR scale score of β₯0.5 in at least one domain and an overall CDR score β€1
β. Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
β. Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition
β. Acute stroke event within 6 months
What they're measuring
1
Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)
. Previously diagnosed hereditary or inflammatory small vessel disease
β. Presence of congenital mental retardation and severe neurological or psychiatric disorders
β. Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation
β. Associated depression (Hamilton Depression Scale score β₯ 17), or other unrelated serious mental illness (schizophrenia, bipolar disorder, or delirium)
β. Combined severe cardiac, pulmonary, and renal insufficiency (creatinine \> 2.0 mg/dl or 177 ΞΌ mol/L), and severe hepatic impairment (aminotransferases more than 3 times normal)
β. Alcoholism, drug addiction, or ongoing use of medications that affect cognitive assessment, such as tranquilizers, sleeping pills, puberty pills, and cholinergics