NCT01220622

Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes

Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 656 (estimated)
• Sponsor: Ministry of Science and Technology of the People´s Republic of China · Other Government
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.

Detailed description

656 patients diagnosed with acute cerebral ischemia disease (onset≤7d) based on ICD-10 and CT/MRI criteria, who have cognitive impairment meeting all of the inclusion criteria and none of the exclusion criteria, will be included and randomized into nimodipine treatment group and the controlled group.Evaluations of cognitive function will be taken at baseline, 1 month, 3 months, and 6 months.

Conditions

• Stroke
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Nimodipine	Administration of nimodipine 30mg tid for 6 months
DRUG	Placebo	Administration of placebo 30mg tid for 6 months

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-04-01
• Completion: 2012-07-01
• First posted: 2010-10-14
• Last updated: 2010-10-14

Locations

1 site across 1 country: China