Actively Recruiting

Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT05072483

Natural History Study of CADASIL

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-05-14

155

Participants Needed

1

Research Sites

997 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: CADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia. Researchers want to monitor people with CADASIL over time. Objective: To learn more about how CADASIL affects a person s blood vessels over time. Eligibility: Adults ages 18 and older who have CADASIL, and healthy volunteers. Design: Participants will be screened with a medical record review. Participants will have 4 study visits over 9 years. Visits will last 6 8 hours per day, for 2 4 days. Participants will give blood and urine samples. They will have an electrocardiogram to record their heart s electrical activity. They will fill out a family tree. They will have tests that measure mental abilities like memory and attention. They may have a skin biopsy. They may have a lumbar puncture. Participants will have an eye exam. Their pupils will be dilated. They will receive a dye via intravenous (IV) line. Pictures will be taken of their eyes. Participants will have an imaging scan of their brain. They may receive a contrast agent via IV. Participants blood flow and blood vessel flexibility will be measured. In one test, a probe will be pressed against the skin of the their wrist, neck, and groin. In another test, they will hold one arm still while a microscope makes videos of the blood flow through a fingernail. In another test, they will perform light exercise or other activities while wearing an elastic band around their head or probes placed on their arm or leg. Healthy volunteers will complete some of the above tests.

CONDITIONS

Official Title

Natural History Study of CADASIL

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to comply with all study procedures and availability for the duration of the study
  • Male or female aged 18 to 100 years (inclusive)
  • Established diagnosis of CADASIL or NOTCH3 mutations by genetic testing, or healthy control status
Not Eligible

You will not qualify if you...

  • Pregnancy at time of consent
  • Lack of capacity to consent without a legally authorized representative
  • Decline to provide blood and/or tissue samples
  • Do not speak English
  • Scans or exams showing brain conditions other than CADASIL that interfere with test interpretation
  • Unable to undergo MRI or presence of internal non-MRI compatible metals (e.g., pacemaker, brain stimulator, shrapnel, surgical metal, clips, cochlear implants, artificial heart valves, metal fragments in eye)
  • Presence of ferromagnetic dental bridges or crowns (exclusion for 7.0T MRI only)
  • Unable to remain supine for up to 1 hour during MRI
  • Uncontrolled head movements
  • Claustrophobia during MRI not controlled by medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

W

William R Whalen, C.R.N.P.

CONTACT

E

Elisa A Ferrante Brenlla, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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