Unraveling the Early Phases of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL)

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Observational
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). 575 participants will be enrolled and can expect to be on study for up to 5 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Must be at least 18 years old

• Positive NOTCH3 genetic testing; OR a positive skin biopsy; OR a willingness to have a NOTCH3 genetic test completed prior to enrolling AND are at-risk for, or diagnosed clinically with, CADASIL

• Willing to commit to three in-person visits (a baseline visit, an 18-month follow-up, and a 36-month follow-up) and to remote visits as needed by phone, email, mail or internet

• Willing to provide documentation of all current medications to study team

• a. All medications will be allowed throughout the course of study. Documentation of medications will be used for analyses to assess potential impact of medications on study outcomes.

• Willing and able to undergo an MRI scan and blood draw at each in-person visit

• Must have a designated study companion

• a. A study companion is someone who knows the participant well (has greater than or equal to 3 hours/month of contact with the CADASIL participant) and can provide additional information to the study team (either remotely or in-person).

• A functional capacity less than 4 on the Modified Rankin Scale

⁃ 1\. Must meet same criteria as CADASIL participants, EXCEPT have negative NOTCH3 genetic testing

Locations
United States
California
University of California
RECRUITING
Los Angeles
University of California
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Denver
Georgia
Georgia State University Research Foundation
RECRUITING
Atlanta
Illinois
Loyola University
RECRUITING
Chicago
New York
Columbia University
RECRUITING
New York
Oregon
Oregon Health & Science University
RECRUITING
Portland
Rhode Island
Brown University
RECRUITING
Providence
Texas
University of Texas Health Science Center
NOT_YET_RECRUITING
Houston
University of Texas
NOT_YET_RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Cadasil Consortium
info@cadasil-consortium.org
1-833-795-3016
Time Frame
Start Date: 2022-06-03
Estimated Completion Date: 2026-01
Participants
Target number of participants: 575
Treatments
Non-Carrier Cohort
About 100 participants who are at-risk, healthy family members with No NOTCH3 Mutation and no symptoms or signs of cognitive decline.
Pre-Symptomatic NOTCH3 Cohort
About 133 participants who are pre-symptomatic, at-risk, and healthy (with verified NOTCH3 mutation) family members with no symptoms.
Symptomatic NOTCH3 Cohort - No Functional Decline
About 134 participants who are symptomatic (with verified NOTCH3 mutation) family members and no functional decline (e.g., mild cognitive impairment (MCI) with premorbid functional levels maintained).
Symptomatic NOTCH3 Cohort - Functional Decline
About 133 participants who are symptomatic family members with a verified NOTCH3 CADASIL mutation and evidence of functional decline consistent with early dementia.
Sponsors
Leads: University of Wisconsin, Madison
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov