Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized, Double-blind, Placebo-controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shenyang First People's Hospital
RECRUITING
Shenyang
Contact Information
Primary
Yi Sui, MD PhD
jakeyisui@icloud.com
+86 24 86861329
Backup
Mingming Dong, MD
dongming_ming@126.com
+86 24 86861329
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 206
Treatments
Experimental: Daphnetin
oral Daphnetin Capsule three capsules/tid for up to six months.
Placebo_comparator: Placebo
oral Placebo (Daphnetin Capsule simulants) three capsules/tid for up to six months.
Sponsors
Leads: First People's Hospital of Shenyang
Collaborators: The Fourth People's Hospital of Shenyang

This content was sourced from clinicaltrials.gov