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.
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
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
Parallel
Daphnetin Capsule
DrugDaphnetin, chemically known as 7,8-dihydroxycoumarin, also known as ZuShiMaJiaSu, is a class of coumarin derivatives derived from different Daphnetin genus plant .
Placebo
DrugThe placebo is a Daphnetin Capsule simulants
Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)
Vascular Dementia Assessment Scale-cognitive subscale（VADAS-cog） is a revision of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) to be a better measure in vascular conditions，The lowest score is 0, with higher scores representing higher levels of cognitive dysfunction and poorer status of the patient.
Incidence of combined endpoints: including new stroke (ischemic Trial of ORG 10172 in Acute Stroke Treatment typing [TOAST typing] or hemorrhagic)/transient ischemic attack, myocardial infarction, new-onset dementia, death
For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis.
Incidence of each individual event of the combined endpoint
For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis.
Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change
Consists of three parts The clinician's impression of change is an assessment of change from baseline, not an assessment of severity. The clinician may refer to his/her own baseline information compiled in Part I when making the assessment of change. The clinician's assessment of impression of change should then be replicated in the main study case report form.The score of CIBIC-plus ranges from 1 to 7, and the score of 1-3 indicates improvement, 4 means no changed, and 5-7 indicates worse.
Change in the Brief Mental State Evaluation Scale (MMSE)
Each correct item is scored as 1 point, and errors are scored as 0 points. The total score ranges from 0 to 30, and the cut-off value for normal and abnormal is related to the level of education; ≤17 points for the illiterate (no education) group, ≤20 points for the elementary school (≤6 years of education) group, and ≤24 points for the secondary school or above (\>6 years of education) group. Cognitive deficits are considered to be below the cut-off value and normal above it.
Click on the lead sponsor to view all of their trials.
First People's Hospital of Shenyang
Lead sponsor
Fourth People's Hospital of Shenyang
Sponsor institution
Fourth People's Hospital of Shenyang
Collaborator
