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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05556395
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke

Detailed Description

It is well known that ischemic stroke is a risk factor for developing dementia. Prior studies have shown that after a stroke, there can be a change in the trajectory of cognitive performance with acceleration of decline. The mechanism of this phenomenon has not been established. It is known that vascular changes in the brain, referred to as cerebral small vessel disease, are associated with cognitive decline and dementia. Cerebral small vessel disease is readily seen on MRI scans of the brain, and the larger the burden of these findings, the higher the risk of cognitive deficits. Disruption of the blood-brain barrier has been implicated in the development of the changes seen on MRI. Acute stroke has been shown to disrupt the blood-brain barrier, even in parts of the brain not directly affect by the stroke. The investigators hypothesize that when there is diffuse blood-brain barrier disruption in response to an acute stroke it sets off a cascade of changes in the brain that lead to post-stroke cognitive decline.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2027
• Anticipated Study Completion Date: Apr 1, 2027

Outcome Measures

Primary Outcome Measures

1. Change in Cognition (Cognitive Decline) [Assessments occur every 6 months for 3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to perform telephone-based cognitive assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Richard Leigh, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05556395
• Other Study ID Numbers: IRB00312030
• First Posted: Sep 27, 2022
• Last Update Posted: Sep 27, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johns Hopkins University: blood-brain barrier; post-stroke cognitive impairment and dementia; vascular cognitive impairment and dementia; Alzheimer's disease and related dementias; stroke
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cognitive Dysfunction

Study Results

No Results Posted as of Sep 27, 2022