Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05677880
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-12-12
Brief Title:
Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy CADASIL Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Unraveling the Early Phases of Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy CADASIL
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is an observational study to better understand the risk factors and progression of CADASIL a leading cause of vascular cognitive impairment and dementia VCID 500 participants will be enrolled and can expect to be on study for up to 5 years
Detailed Description:
Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy CADASIL is the most common monogenic vascular dementia Individuals with CADASIL are destined to develop vascular cognitive impairment and dementia VCID which can be studied in pre-symptomatic and prodromal disease stages to detect the earliest changes in biological fluids neuroimaging and the emerging phenotype of symptomatic VCID
The objective of the proposed research is to exploit an autosomal dominant vascular dementia as a model to investigate specific features of VCID and to examine interactions with risk factors impacting the aging life course
The study will enroll a total of 500 participants with a CADASIL family history who have had a genetic test for a NOTCH3 variant Participants will complete a clinical interview a neurological exam neurocognitive and behavior assessments MRI and a blood draw at each study visit Participants will complete 3 in-person visits in total as part of this study baseline visit 2 18 months after baseline visit 3 36 months after baseline Additional contact will occur by phone mail email or the internet as needed and will be referred to as remote visits
The objective of the proposed research is to exploit an autosomal dominant vascular dementia as a model to investigate specific features of VCID and to examine interactions with risk factors impacting the aging life course
The study will enroll a total of 500 participants with a CADASIL family history who have had a genetic test for a NOTCH3 variant Participants will complete a clinical interview a neurological exam neurocognitive and behavior assessments MRI and a blood draw at each study visit Participants will complete 3 in-person visits in total as part of this study baseline visit 2 18 months after baseline visit 3 36 months after baseline Additional contact will occur by phone mail email or the internet as needed and will be referred to as remote visits
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Neurology-Gen | OTHER | UW Madison | httpsreporternihgovquickSearch1RF1AG074608-01 |
| 2021-6179 | OTHER | None | None |
| 1RF1AG074608-01 | NIH | None | None |
| Protocol Version 70 | OTHER | None | None |