Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke

NCT06344390 | Recruiting Phase 1 DMC

• 1 other identifier: 20210327
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

Pentoxifylline

Drug: Pentoxifylline

No intervention

NO INTERVENTION

No intervention

Interventions

Pentoxifylline DRUG

Take pentoxifylline 0.4 g twice daily

Also known as: CSPC Pharmaceutical Group

Pentoxifylline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

BHan

Shijiazhuang, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jiaying Rong, master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Han, Ph.D. degree

CONTACT

13784333398; Hanbing1987@hebmu.edu.cn

Jiaying Rong, master

CONTACT

15241876265; rjy19982023@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: April 3, 2024
• Study Start: April 10, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)