Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorFirst People's Hospital of Shenyang

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Daphnetin Capsule
  • Placebo

Treatment groups

206 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First People's Hospital of Shenyang

Lead sponsor

Fourth People's Hospital of Shenyang

Sponsor institution

The Fourth People's Hospital of Shenyang

Collaborator