Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

NCT05556395 | Recruiting

• 1 other identifier: IRB00312030
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.

Conditions

Ischemic Stroke

Keywords

blood-brain barrier; post-stroke cognitive impairment and dementia; vascular cognitive impairment and dementia; Alzheimer's disease and related dementias; stroke

Outcome Measures

Primary Outcomes (1)

• Change in Cognition (Cognitive Decline)

  Serial telephone-based cognitive assessments will be performed to detect cognitive changes (cognitive decline).

  Assessments occur every 6 months for 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are admitted to the hospital and diagnosed with an ischemic stroke based on an MRI scan that also includes perfusion imaging with an exogenous contrast agent and are will/able to be contacted for serial phone-based cognitive evaluations.

You may qualify if:

• Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent

You may not qualify if:

• Inability to perform telephone-based cognitive assessments

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Dementia; Alzheimer Disease; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Richard Leigh, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Echavarria

CONTACT

410 502 5355; dechava1@jhu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)