DCE-MRI for Cognitive Outcomes After Stroke

Overseen By Muhith Musabbir

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: IL-1 blockers

Disqualifiers: Stroke, Dementia, Renovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a stroke affects the brain over time, particularly regarding thinking and memory. Researchers seek to determine whether the blood-brain barrier (a protective shield for the brain) remains affected long after a stroke and if certain blood markers can predict mental decline. Participants will undergo cognitive tests and brain scans two years apart. The trial seeks individuals who have experienced a stroke or have other heart-related issues, such as high blood pressure or diabetes.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future stroke care and prevention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on certain immune-suppressant therapies or have been treated with them in the last 3 months.

What prior data suggests that this protocol is safe for cognitive testing and MRIs in stroke patients?

Research shows that StrokeCog-BBB aims to understand how strokes affect thinking and memory. This study does not involve testing any new drugs or medical procedures. As an observational study, it carries a very low safety risk. Participants will undergo cognitive tests and MRI scans, conducted two years apart. These procedures are common and generally very safe.

Other studies have shown that MRI scans are well-tolerated, with rare side effects typically related to magnets if metal implants are present. Cognitive tests are non-invasive and do not pose any risk to physical health.

Overall, this study does not test new treatments, so there are no safety concerns about new drugs or procedures. The study focuses on observing and collecting data, which are safe methods to learn more about recovery after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the StrokeCog-BBB trial because it aims to uncover how strokes might affect cognitive outcomes, which is a crucial area that needs more understanding. Unlike traditional treatments that focus primarily on physical rehabilitation or prevention of future strokes, this study looks into the brain's cognitive functions after a stroke, potentially offering insights into new therapeutic approaches. By studying both individuals with a history of stroke and those with cardiovascular risk factors but no stroke history, the trial seeks to identify unique patterns and mechanisms behind cognitive changes. This could pave the way for developing targeted therapies that not only support recovery but also enhance cognitive health post-stroke.

What evidence suggests that this trial's methods could be effective for understanding cognitive outcomes after stroke?

Previous studies have shown that having a stroke doubles the risk of developing dementia for at least ten years, even when accounting for other risk factors. About 40% of stroke survivors experience memory and thinking problems within a year after their stroke, and 10% to 20% may develop dementia. The StrokeCog-BBB trial is examining how the blood-brain barrier, a protective shield for the brain, might be affected after a stroke, potentially explaining some of these memory and thinking issues. Researchers are also investigating biological markers in the blood that might predict memory and thinking decline. These findings suggest that understanding these factors could aid in predicting and managing memory and thinking decline in stroke patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Marion Buckwalter, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

You are 45 years of age or older.

You have a history of coronary artery disease, chest pain or placement of a stent in the peripheral vasculature.

You possess one or more risk factors associated with vascular conditions, such as elevated blood pressure, diabetes, angina, prior myocardial infarction, coronary revascularization surgery or lower limb arteriopathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo initial cognitive testing and MRI imaging

1-2 weeks

1 visit (in-person)

Observational Period

Participants are monitored for cognitive outcomes and blood-brain barrier permeability

2 years

2 visits (in-person, 2 years apart)

Follow-up

Participants are monitored for safety and effectiveness after the observational period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• StrokeCog-BBB

How Is the Trial Designed?

Group I: Stroke Experimental Treatment 1 Intervention

Patients who have a history of stroke will be in the first group.

Group II: Control Experimental Treatment 1 Intervention

Patients who do not have a history of stroke, but have a history of cardiovascular risk factors will be in the second group.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of Manchester

Collaborator

Trials

370

Recruited

621,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06116630

StrokeCog-BBB to Study Cognitive Outcomes Following ...

The goal of this observational study is to learn about cognitive outcomes in stroke patients. The main question it aims to answer are: 1. Is blood-brain barrier ...

2.

trialx.com

trialx.com/clinical-trials/listings/267426/strokecog-bbb-to-study-cognitive-outcomes-following-stroke/

StrokeCog-BBB to Study Cognitive Outcomes Following ...

Having a stroke approximately doubles the risk of incident dementia for at least a decade afterwards, even after accounting for other vascular ...

3.

clinicaltrials.stanford.edu

clinicaltrials.stanford.edu/trials/s/NCT06116630.html

StrokeCog-BBB to Study Cognitive Outcomes Following Stroke

The goal of this observational study is to learn about cognitive outcomes in stroke patients. The main question it aims to answer are:

4.

hrbopenresearch.org

hrbopenresearch.org/articles/8-59

StrokeCog-R: Protocol for a Pilot Randomised...

Post-stroke cognitive impairment (PSCI) affects approximately 40% of stroke survivors within one year, yet cognitive rehabilitation is not ...

5.

ahajournals.org

ahajournals.org/eprint/PRGBSY32WHVPQ9KBHQY7/full?doi=10.1161/STROKEAHA.121.034005

StrokeCog Markov Model: Projected Prevalent and Incident ...

Just under 40% of those experiencing a stroke have cognitive impairment no dementia (CIND) at 1-year poststroke, and 10% to 20% have dementia. Systematic review ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/STR.0000000000000430

Cognitive Impairment After Ischemic and Hemorrhagic Stroke

Cognitive impairment is a common consequence of stroke and has direct implications for poststroke functioning and quality of life, ...