RecruitingNot Applicable

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

United States660 participantsStarted 2022-06-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Willing and able to undergo an MRI scan and blood draw at each in-person visit
✓. Must have a designated "study companion"
✓. A functional capacity less than 4 on the Modified Rankin Scale

Exclusion criteria

✕. 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

What they're measuring

Performance Measured by Change in Cognitive Executive Function Composite Z-Score

Timeframe: baseline and 36 months

Change in total brain volume between baseline and 36 months

Timeframe: baseline and 36 months

Change in total cerebral spinal volume between baseline and 36 months

Timeframe: baseline and 36 months

Percent change in brain connectivity from baseline to 36 months

Timeframe: baseline and 36 months

Change in Neurofilament Light (Nfl)

Timeframe: baseline and 36 months

Change in World Health Organization Disability Assessment Schedule (WHODAS) Score

Timeframe: baseline and 36 months

Change in CADASIL Severity Score

Timeframe: baseline and 36 months

Trial details

NCT IDNCT05677880

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06

Contact for this trial

Cadasil Consortium

1-833-795-3016 info@cadasil-consortium.org

View on ClinicalTrials.gov More CADASIL trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Willing and able to undergo an MRI scan and blood draw at each in-person visit
✓. Must have a designated "study companion"
✓. A functional capacity less than 4 on the Modified Rankin Scale

Exclusion criteria

✕. 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

What they're measuring

Performance Measured by Change in Cognitive Executive Function Composite Z-Score

Timeframe: baseline and 36 months

Change in total brain volume between baseline and 36 months

Timeframe: baseline and 36 months

Change in total cerebral spinal volume between baseline and 36 months

Timeframe: baseline and 36 months

Percent change in brain connectivity from baseline to 36 months

Timeframe: baseline and 36 months

Change in Neurofilament Light (Nfl)

Timeframe: baseline and 36 months

Change in World Health Organization Disability Assessment Schedule (WHODAS) Score

Timeframe: baseline and 36 months

Change in CADASIL Severity Score

Timeframe: baseline and 36 months