Cognitive impairment comorbid with focal epilepsy in elderly patients
Conditions
Interventions
Butylphthalide Treatment Group: DL-3-n-butylphthalide soft capsules 0.1g per capsule, 2 capsules (0.2g) three times daily, taken orally after meals, continuously for 48 weeks
Placebo Control Group:Placebo soft capsules identical in appearance, weight, and smell to butylphthalide capsules, 2 capsules three times daily, taken orally after meals, continuously for 48 weeks
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60-85 years (inclusive), any gender 2. Focal epilepsy meeting ILAE 2025 latest seizure classification criteria, disease duration >=2 years 3. Currently receiving anti-seizure medications with stable dosage >=3 months, good seizure control (monthly seizure frequency <=4 times in recent 3 months) 4. Cognitive impairment: Montreal Cognitive Assessment (MoCA) score 18-25 points 5. Basic Chinese language comprehension and expression ability, able to complete neuropsychological tests 6. Signed informed consent, voluntary participation in the study
Exclusion criteria
Exclusion criteria: 1. Definitive diagnosis of various types of dementia (meeting DSM-5 dementia diagnostic criteria) 2. Clear history of stroke with corresponding lesions on neuroimaging, or severe white matter lesions on brain MRI 3. Other neurological diseases that may cause cognitive impairment (traumatic brain injury, encephalitis, hydrocephalus, etc.) 4. Systemic diseases that may cause cognitive impairment (severe cardiac, hepatic, renal dysfunction, endocrine diseases, etc.) 5. Current severe depression or other psychiatric disorders affecting cognitive assessment 6. History of alcohol dependence, substance abuse, or other substance use affecting cognitive function 7. Allergy to butylphthalide or its excipients 8. Participation in other drug clinical trials within 30 days 9. Other conditions deemed unsuitable for participation by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MoCA total score from baseline to week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in neuropsychological test scores;Seizure control related indicators;Functional status and quality of life assessment indicators;Safety and tolerability evaluation indicators; | — |
Countries
China
Contacts
Public ContactXu Huiqin
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed