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A prospective multicenter real-world clinical study on the efficacy and safety of edaravone and dexbornol in the prevention and treatment of cognitive impairment after acute minor ischemic stroke in patients with cerebral small vessel disease

A prospective multicenter real-world clinical study on the efficacy and safety of edaravone and dexbornol in the prevention and treatment of cognitive impairment after acute minor ischemic stroke in patients with cerebral small vessel disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055495
Enrollment
Unknown
Registered
2022-01-10
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral small vessel disease (CSVD)

Interventions

Edaravone dexborneol group:Nil
control group:None

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-85 years, gender is not limited; 2. Acute lacunar cerebral infarction ( Acute lacunar cerebral infarction ( NHISS score 2 points); 3. The patient has no cognitive impairment, or has mild function (CDR < 1 point).

Exclusion criteria

Exclusion criteria: 1. Have a history of familial genetic dementia; 2. Suffering from any cause of disorder of consciousness; 3. Those with severe aphasia or physical disability who cannot complete the neuropsychological examination; 4. Those who currently suffer from related depression (score of Hamilton scale>17) or mental illness; 5. Have a history of alcoholism, or drug addiction, traumatic brain injury, epilepsy, normal intracranial pressure, etc., which can cause cognitive impairment, have a history of alcoholism, or drug addiction, traumatic brain injury, epilepsy, normal intracranial pressure, etc. can cause cognitive impairment, history of alcoholism, or drug addiction, traumatic brain injury, epilepsy, normal intracranial pressure, etc. can cause cognitive impairment, history of alcoholism, or drug addiction, traumatic brain injury, epilepsy, normal intracranial pressure, etc. can cause cognitive impairment, history of alcoholism, or drug addiction, traumatic brain injury, epilepsy, normal intracranial pressure, etc. can cause cognitive impairment, history of alcoholism, or neurological diseases that can cause cognitive impairment, such as brain trauma, epilepsy, normal intracranial pressure, or drug addiction; 6. Suffering from systemic diseases that may lead to mild cognitive impairment (such as liver and kidney insufficiency, endocrine vitamin deficiency); 7. Long-term use of others that affect the safety or effectiveness of the test drug, such as antipsychotics; 8. Patients who cannot accept brain MRI; 9. Patients who are participating in other studies; 10. Pregnant patients or women of reproductive age and breastfeeding; 11. Other circumstances that the researcher considers unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with Clinical Dementia Rating Scale (CDR) score <1;

Secondary

MeasureTime frame
The proportion of patients with MTx-%C>78%;Change in MMSE scale score from baseline;Change in MoCA scale score from baseline;Changes from baseline in daily living function scale (ADL) scores;Change from baseline in neuropsychiatric questionnaire (NPI);Differences in Hamilton Depression/Anxiety Scale Scores (HAMD/HAMA);Changes of serological inflammatory markers compared with baseline values and differences between groups;Change from baseline in CSVD overall load score;Default subgroup analysis;

Countries

China

Contacts

Public ContactLiu Xiaolei
ringlxl@163.com+86 13888812292

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026