vascular cognitive impairment no dementia
Conditions
Interventions
Group A:Duxil
Group B:Placebo
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: Selection criteria: (1) Informed consent; (2) Age>=55; (3) With good vision and hearing, able to participate in the clinical trial; (4) With at least one vascular risk factor (such as hypertension, diabetes mellitus, hyperlipidemia, coronary heart disease, atrial fibrillation, carotid artery disease, peripheral vascular disease, smoking, etc.); (5) Complaints of cognitive impairment for at least 6 months. If it is caused by stroke, the cognitive impairment must appear within 3 months after stroke; (6) Total cognitive assessment is normal, MMSE > 24 (Junior high school and above group), > 20 (Primary school group), >17 (Illiterate group); (7) The activity of daily living is not affected (excluding extremity disability), that is ADL<23; (8) CDR=0.5, not meeting with diagnostic criteria of dementia. Inclusion criteria: (1) Meet the selection criteria; (2) MRI shows cerebrovascular disease(s) (ischemic stroke and/or white matter lesion); (3) One or more cognitive domain damage by neuropsychological assessment.
Exclusion criteria
Exclusion criteria: (1) Uncooperative in the course of the study (for severe psychiatric disorders, etc.), or unable to take the scheduled examination and visit, or not complying with study instructions; (2) Lack of or only with limited action ability in law; (3) Has been participating in the recent 3 months or is participating now in other clinical trial(s); (4) Disturbance of consciousness for any cause; (5) Unable to complete neuropsychologic examination for severe aphasia or disability; (6) Known depression (meeting the standard of DSM-IV) and psychiatric disorders; (7) Automatic recovery of cognitive impairment caused by acute cerebrovascular disease; (8) Known systemic diseases that may possibly induce mild cognitive impairment (e.g. Hepatic/renal dysfunction, heart diseases, thyroid/parathyroid diseases and vitamin deficiency); (9) All the diagnosed nervous system diseases that may possibly induce cognitive impairment (e.g. cerebral trauma, epilepsy,encephalitis, hydrocephalus with normal intracranial pressure, brain tumor, etc); (10) Known peripheral neuropathy; (11) With the history of dementia; (12) Any possible diseases that may intervene the study; (13) Alcohol or drug abuser; (14) Current use of antipsychotics, antianxiety, hypnotics or any medication containing almitrine or raubasine; (15) With other severe diseases (such as tumor), life expectancy may be shorter than the clinical study span; (16) Known allegic to Duxil or adverse drug reaction caused by Duxil; (17) Planned to receive operation during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog; | — |
Secondary
| Measure | Time frame |
|---|---|
| CIBIC-Plus;MMSE;IADL;NPI;Wechsler's digit-symbol test;Digit span reverse recite test;language fluenc; | — |
Countries
China
Contacts
Public ContactProf. Jianping Jia
Outcome results
None listed