NCT05677880 Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) Study
| NCT ID | NCT05677880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | CADASIL |
| Study Type | OBSERVATIONAL |
| Enrollment | 660 participants |
| Start Date | 2022-06-03 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 660 participants in total. It began in 2022-06-03 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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). 575 participants will be enrolled and can expect to be on study for up to 5 years.
Eligibility Criteria
Inclusion Criteria for CADASIL Participants: 1. Must be at least 18 years old 2. 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 3. 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 4. 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. 5. Willing and able to undergo an MRI scan and blood draw at each in-person visit 6. 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). 7. A functional capacity less than 4 on the Modified Rankin Scale Inclusion Criteria for Healthy Controls (HC): 1\. Must meet same criteria as CADASIL participants, EXCEPT have negative NOTCH3 genetic testing Exclusion Criteria: 1. History of severe learning disability, intellectual disability, or other neurological disease or event not attributable to CADASIL 2. History of serious alcohol or drug abuse within the past year 3. Unwilling to undergo NOTCH3 genetic testing if there is no test on file
Contact & Investigator
Jane S Paulsen, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT05677880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CADASIL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05677880 currently recruiting?
Yes, NCT05677880 is actively recruiting participants. Contact the research team at info@cadasil-consortium.org for enrollment information.
Where is the NCT05677880 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Denver, United States, Atlanta, United States and 8 additional locations.
Who is sponsoring the NCT05677880 clinical trial?
NCT05677880 is sponsored by University of Wisconsin, Madison. The principal investigator is Jane S Paulsen, PhD at University of Wisconsin, Madison. The trial plans to enroll 660 participants.