RecruitingNCT05677880

Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) Study

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


Sponsor

University of Wisconsin, Madison

Enrollment

660 participants

Start Date

Jun 3, 2022

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

Min Age: 18 Years

Inclusion Criteria10

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

Exclusion Criteria3

  • History of severe learning disability, intellectual disability, or other neurological disease or event not attributable to CADASIL
  • History of serious alcohol or drug abuse within the past year
  • Unwilling to undergo NOTCH3 genetic testing if there is no test on file

Interested in this trial?

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Interventions

OTHERStudy Procedures

Participants will experience * Neurocognitive Tests and Self-Report Measures * Clinical Interviews * Neurological Exam * MRI screening at baseline, 18 months, 36 months * Fasted Blood draw


Locations(12)

University of California

Los Angeles, California, United States

University of California

San Francisco, California, United States

University of Colorado

Denver, Colorado, United States

Georgia State University Research Foundation

Atlanta, Georgia, United States

Loyola University

Chicago, Illinois, United States

Columbia University

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Brown University

Providence, Rhode Island, United States

University of Texas Health Science Center

Houston, Texas, United States

University of Texas

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05677880