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RecruitingNCT06344390Updated Apr 3, 2024

Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke

A Phase 1/2 interventional study of Pentoxifylline in Cognitive Impairment, sponsored by The First Hospital of Hebei Medical University. Recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by The First Hospital of Hebei Medical University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cognitive Impairment
03

In context

Ischemic Stroke

2,595 studies on the registry are indexed under Ischemic Stroke; 932 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 1,754 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

The First Hospital of Hebei Medical University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Pentoxifylline

    Pentoxifylline

    Drug: Pentoxifylline

  • No intervention
    No intervention

    No intervention

Interventions

  • DrugPentoxifylline

    Take pentoxifylline 0.4 g twice daily

    Also known as: CSPC Pharmaceutical Group

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06344390
Lead sponsor
The First Hospital of Hebei Medical University
Responsible party
Bing Han (associate chief physician, The First Hospital of Hebei Medical University) — Principal investigator
First posted
Apr 3, 2024
Start date
Apr 10, 2024 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 3, 2024

Study contacts

Bing Han, Ph.D. degree
Contact
Hanbing1987@hebmu.edu.cn
13784333398
Jiaying Rong, master
Contact
rjy19982023@163.com
15241876265
Jiaying Rong, master
principal investigator · The First Hospital of Hebei Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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