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

NCT01220622 | Unknown Phase 4 DMC

• 1 other identifier: BSP-SOP-040
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Mild Cognitive Impairment

Keywords

Stroke; Mild cognitive impairment; Nimodipine

Outcome Measures

Primary Outcomes (1)

• Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population

  6 months

Secondary Outcomes (6)

• Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population

  6 months

• The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months

  6 months

• Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 3 months in the ITT population

  3 months

• Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population

  3 months

• The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month

  1 month

Study Arms (2)

Nimodipine

ACTIVE COMPARATOR

Drug: Nimodipine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nimodipine DRUG

Administration of nimodipine 30mg tid for 6 months

Also known as: Nimodiping Pian

Nimodipine

Placebo DRUG

Administration of placebo 30mg tid for 6 months

Also known as: Control group

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects between 30 and 80 years.
• \. ICD-10 and CT/MRI criteria for acute cerebral infarction.
• \. Stroke within 7 days after onset.
• based on years of education correction.MMSE\>17(illiteracy),MMSE\>20(primary school),MMSE\>24(others)
• \. MoCA≤26 at baseline.
• Hachinski ischemic score ≥7 at baseline.
• Expected good compliance to study.
• Informed consent signed.

You may not qualify if:

• Diagnosis of schizophrenia, major anxiety syndrome, major depression.
• Alzheimer disease, Parkinson disease, Huntington disease, and fronto-temporal dementia.
• Dementia caused by (e.g., central nervous system trauma, tumor, infections, metabolic disorders, normal pressure hydrocephalus, lack of folic acid or vitamin B12, or thyroid hormone deficiency).
• Contraindications to dihydropyridine derivatives.
• Aphasia or other diseases that affect cognitive evaluation.
• Serious arrhythmias, bradycardia (\<50 bpm) or tachycardia (\>120 bpm); myocardial infarction within the past 6 months; blood pressure \<90/60mmHg; severe renal or hepatic insufficiency; severe anemia, Hb\<100g/L; severe gastrointestinal disorders; tumor.
• History of epilepsy, use of the antiepileptic drugs.
• CT/MRI showed neurodegenerative changes or other lesions except cerebral ischemia.

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, China

RECRUITING

Related Publications (1)

• Zheng H, Wang Y, Wang A, Li H, Wang D, Zhao X, Wang P, Shen H, Zuo L, Pan Y, Li Z, Meng X, Wang X, Shi W, Ju Y, Liu L, Dong K, Wang C, Sui R, Xue R, Pan X, Niu X, Luo B, Sui Y, Wang H, Feng T, Wang Y; NICE trial group. The efficacy and safety of nimodipine in acute ischemic stroke patients with mild cognitive impairment: a double-blind, randomized, placebo-controlled trial. Sci Bull (Beijing). 2019 Jan 30;64(2):101-107. doi: 10.1016/j.scib.2018.12.006. Epub 2018 Dec 8.

  PMID: 36659633 DERIVED

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Nimodipine; Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Wang Yongjun, M.D.

  Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng tao, M.D.

CONTACT

00861067098343; happyft@sina.com

Wang xuemei, M.D.

CONTACT

minnie_wxm@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

CN (1)