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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344390
Other study ID # 20210327
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 10, 2024
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source The First Hospital of Hebei Medical University
Contact Bing Han, Ph.D. degree
Phone 13784333398
Email Hanbing1987@hebmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function. The patients with cognitive impairment and non-dementia PSCIND after ischemic stroke were randomly divided into two groups. In addition to the basic drugs of ischemic stroke, the patients were given pentothemine sustained release tablets and blank control respectively to observe the effects of pentothemine on cognitive function and neuronal electrical signals in the patients with ischemic PSCIND. It is expected to explore the possible internal biological mechanism by using transcranial Doppler, oxygen-dependent functional magnetic resonance imaging and craniocerebral magnetic resonance pop analysis. Finally, statistical correlation analysis was used to elucidate the specific mechanism of pentoxifylline in improving cognitive function of non-dementia patients with cognitive impairment after ischemic stroke.


Description:

Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Han Chinese, age 40-80 years old, male and female, right-handed; - The diagnosis is consistent with the Expert Consensus on the Management of Cognitive Impairment after Stroke 2021; - NIHSS score 1-15 points; - Daily Living Ability Scale (ADL) =75 score; - The Informed consent signed by the patient or his legal representative Exclusion Criteria: - Can not cooperate with the examination (including neuropsychological tests and scale assessment); - There were memory disorders, dementia with lewy bodies and frontotemporal dementia before the onset of stroke events; - There were definite infectious diseases 2 weeks before admission; Have a serious mental illness, previous history of cancer, alcohol or drug abuse; - Use of drugs that may affect cognitive function, including sedatives, anti-anxiety drugs, hypnotics, nootropic drugs, and cholinoid drugs; - Can not accept brain MRI examination

Study Design


Intervention

Drug:
Pentoxifylline
Take pentoxifylline 0.4 g twice daily

Locations

Country Name City State
China BHan Shijiazhuang

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pentoxifylline can improve cognitive impairment after ischemic stroke The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool For Mild Cognitive Impairment.If the score is less than 26 points, it is considered to have cognitive impairment.Patient scores get higher after 3 months, we think pentoxifylline can improve cognitive impairment after ischemic stroke. 3 months
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