Non-dementia vascular cognitive impairment
Conditions
Interventions
Group A:Nicergolin 10 mg 3 times a day
Group B:????20mg ????
Control group:Background therapies
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) >=18 years old, gender is not limited; (2) A history of acute ischemic stroke within 6 months prior to screening; (3) The patient's current stroke condition is stable and the modified Rankin score ?2 points; (4) Hachiski ischemic scale?7 points; (5) Magnetic resonance imaging (MRI) supports any of the following imaging findings: cerebral white matter hyperdensities (WMH), enlarged perivascular spaces (PVS) in basal ganglia, lacunar infarcts or/and brain atrophy; (6) MMSE score >17, 20 or 24 scores for subjects of illiterate, 1-6 educational years or above 7 educational years, respectively); (7) MoCA 12 educational years or <25 scores for <= 12 educational years; (8) No nicergolin, nimodipine or butylphthalide is taken within 4 weeks before randomization; (9) Life expectancy is greater than 12 months; (10) He/she can understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) A history of cognitive impairment or other important neurological disorders prior to the current ischemic stroke event; (2) Have a history of severe depression or other mental illness; (3) Aphasia or other severe disability, unable to effectively cooperate with neuropsychiatric assessment; (4) Alcohol abuse or drug abuse in the judgement of investigator; (5) Major surgery (except vasclular stent placement) performed within 28 days prior to screening. (6) Participating in other clinical trials within 14 days before screening; (7) Moderated to severe gastrointestinal, liver or/and renal dysfunction in the judgment of investigators, (8) Combinded severe cardiovascular disorders, such as congenital heart failure level III or above, severe arrythmia etc. (9) Morderate to severe active infection in the judgement of investigator; (10) Previously received allogeneic bone marrow transplantation; (11) The patients with diabetes or other serious system diseases/injuries, such as rheumatism, malignant tumors, etc, with poor control,. in the judgment of investigators; (12) Pregnant or lactating women; (13) For women who have fertility before menopause (postmenopausal women must have been menopausal for at least 12 months to be considered to have no fertility); or by the investigator judging that during the study period and within 3 months after the last dose of study drug, there is a willingness to become pregnant, breastfeeding, or unwilling to adopt effective contraceptive measures (including male subjects and their spouses of childbearing age); (14) The investigator believes that the patient has any disease or medical condition that is unstable or may affect its safety or research compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in VaDAS-Cog score at week 24.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in VaDAS-Cog score at week 12.;Change from baseline in MMSE score at week 12 and week 24.;Change from baseline in MoCA score at week 12 and week 24.; | — |
Countries
China
Contacts
Public ContactXingquan Zhao
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed