Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284213
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-16
Brief Title:
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MarkVCID
Brief Summary:
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia MarkVCID is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems Alzheimers disease and other dementias leave signatures on brain scans or in the blood called biomarkers The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss
Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes However research and patient care can be held back by limited biomarkers that identify who should be treated
The MarkVCID Consortium includes 17 US medical centers a Coordinating Center an External Advisory Committee and NIH leadership Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories so that researchers can use this information to study brain function
Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes However research and patient care can be held back by limited biomarkers that identify who should be treated
The MarkVCID Consortium includes 17 US medical centers a Coordinating Center an External Advisory Committee and NIH leadership Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories so that researchers can use this information to study brain function
Detailed Description:
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia MarkVCID is an NIH-funded multisite consortium dedicated to developing promising predictive diagnostic target engagement and progression candidate biomarkers of small vessel disease in VCID MarkVCID is a collaborative consortium of nine North American research sites consisting of 17 institutions nationwide a Coordinating Center External Advisory Committee and NIH leadership
MGH serves as the Consortiums Coordinating Center and is comprised of an administrative and data core providing participating research sites with a common support infrastructure that facilitates cross-site collaborations oversees development of standard operating procedures and data collection methods and manages consortium-wide data
In phase two of the MarkVCID study research sites are charged with enrolling and following 200 diverse human subjects with cognitive complaints andor early symptomatic stages of cognitive impairment and dementia potentially associated with cerebrovascular small vessel disease Sites will share data with the Coordinating Center which will be used for validation studies of chosen consortium biomarkers Throughout the duration of the study sites will utilize harmonized procedures and data collection methods to engage in multi-site biomarker validation Both Cores comply with regulations for the protection of human research subjects including Good Clinical Practices GCP 21 Code of Federal Regulations CFR and with the International Conference on Harmonization ICH Regulations E2A and E6
MGH serves as the Consortiums Coordinating Center and is comprised of an administrative and data core providing participating research sites with a common support infrastructure that facilitates cross-site collaborations oversees development of standard operating procedures and data collection methods and manages consortium-wide data
In phase two of the MarkVCID study research sites are charged with enrolling and following 200 diverse human subjects with cognitive complaints andor early symptomatic stages of cognitive impairment and dementia potentially associated with cerebrovascular small vessel disease Sites will share data with the Coordinating Center which will be used for validation studies of chosen consortium biomarkers Throughout the duration of the study sites will utilize harmonized procedures and data collection methods to engage in multi-site biomarker validation Both Cores comply with regulations for the protection of human research subjects including Good Clinical Practices GCP 21 Code of Federal Regulations CFR and with the International Conference on Harmonization ICH Regulations E2A and E6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None