Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179797
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-12
Brief Title:
Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment A Dose Escalation Study
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment A Dose Escalation Study
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
To evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in patients with age-related cerebral white matter hyperintensities on MRI in preparation for a subsequent larger efficacy trial
Detailed Description:
Objective The objective of this early phase study is to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in preparation for a subsequent larger efficacy trial In addition we will evaluate the tolerability and adherence to the treatment protocol
Aim We aim to measure blood biomarkers in response to daily remote ischemic conditioning RIC using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI
Hypothesis We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion
Aim We aim to measure blood biomarkers in response to daily remote ischemic conditioning RIC using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI
Hypothesis We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion
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