Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

NCT06507488 | Recruiting DMC

• 1 other identifier: RXSJNJLXD-2024-SYSY
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebrovascular Disorders

Keywords

Vascular Cognitive Impairment No Dementia; Daphnetin; Effectiveness; safety

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (11)

• 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

  6 months

• Incidence of each individual event of the combined endpoint

  6 months

• Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change

  6 months

• Change in the Brief Mental State Evaluation Scale (MMSE)

  6 months

• Change in the Montreal Cognitive Assessment Scale (MoCA)

  6 months

Study Arms (2)

Daphnetin

EXPERIMENTAL

oral Daphnetin Capsule three capsules/tid for up to six months.

Drug: Daphnetin Capsule

Placebo

PLACEBO COMPARATOR

oral Placebo (Daphnetin Capsule simulants) three capsules/tid for up to six months.

Drug: Placebo

Interventions

Daphnetin Capsule DRUG

Daphnetin, chemically known as 7,8-dihydroxycoumarin, also known as ZuShiMaJiaSu, is a class of coumarin derivatives derived from different Daphnetin genus plant .

Also known as: 7,8-dihydroxycoumarin

Daphnetin

Placebo DRUG

The placebo is a Daphnetin Capsule simulants

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• First People's Hospital of Shenyang: lead
• The Fourth People's Hospital of Shenyang: collaborator

Study Sites (1)

Shenyang First People's Hospital

Shenyang, Liaoning, 110041, China

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

daphnetin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yi Sui, MD PhD

  The Fourth People's Hospital of Shenyang, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Sui, MD PhD

CONTACT

+86 24 86861329; jakeyisui@icloud.com

Mingming Dong, MD

CONTACT

+86 24 86861329; dongming_ming@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 7, 2025
• Primary Completion: July 7, 2025
• Study Completion: April 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)