Observational Study on Cognitive Outcomes After Stroke

This observational study, called StrokeCog-BBB, is looking into how stroke affects thinking and memory over time. Researchers want to understand if leaky blood vessels in the brain (blood-brain barrier permeability) and certain blood markers are connected to cognitive decline after a stroke. You might be able to join if you are between 45 and 90 years old, have vascular risk factors like high blood pressure or diabetes, and can speak and write in English. The study will involve cognitive (thinking and memory) tests and special MRI scans (DCE-MRI) two years apart. The goal is to find ways to predict who might experience cognitive decline after a stroke. The current status of this study is unclear.

Study design
This is an observational study with a planned enrollment of 350 participants. It compares cognitive outcomes in stroke patients to non-stroke patients with similar cardiovascular risk factors.
What's involved
Participants will undergo cognitive testing and MRI scans two years apart. Both groups will have DCE-MRIs (a type of diagnostic imaging).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, including the correlation of leaky blood vessels and blood biomarkers with cognitive scores, will be measured at 4 years.

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NCT06116630

StrokeCog-BBB to Study Cognitive Outcomes Following Stroke

Recruiting
Not specifiedAges 45–90Observational
Stanford University
~350 participants
Updated 2024-04-18 on ClinicalTrials.gov
What's tested:DCE-MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of leaky blood vessels in the brain and cognitive scores
Measured over 4 years
+1 more outcome measured
Stroke

NCT06116630

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University Hospital

    Palo Alto, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Marion Buckwalter, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Eligibility criteria

Inclusion

Aged 45 years or over
One or more vascular risk factors (e.g. high blood pressure, diabetes or vascular disease such as angina, a previous heart attack, a heart bypass or peripheral artery disease in the legs)
Established vascular disease (previous MI, angina, vascular stent in the peripheral bed)
Sufficiently fluent in written and spoken English
Living independently in the community
Willing/able to give consent to study participation.

Exclusion

Current treatment with IL-1 blockade or established immune-suppressant therapy (e.g. IL-1Ra or IL-1 antibodies), or treatment within the last 3 months
Currently participating in a clinical trial of investigation medicinal product (CTIMP) or device trial.
No history of any previous ischaemic or haemorrhagic stroke, a mini-stroke or a serious brain injury
Do not have dementia
Renovascular Disease
Major neurological disease (immune mediated, previous brain tumors)
  • Correlation of leaky blood vessels in the brain and cognitive scores4 years

    Patients will undergo MRI imaging and cognitive testing. Amount of leakage in the blood vessels with be quantified. Scores on the cognitive tests will be normalized with Z scores. The amount of leakage and the z scores will be correlated to better understand the relationship between blood brain barrier leakage and cognition.

  • Correlation of blood biomarkers and cognitive scores4 years

    Blood will be drawn and analyzed for biomarkers, and the biomarkers concentration will be correlated with the z scores from their cognitive tests.