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NIH launches study to unravel mysteries of rare genetic brain disease CADASIL

NCT ID NCT02821780

Knowledge-focused Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 15 times

Summary

This study looked at 20 people with CADASIL, a rare genetic disease that damages brain arteries and causes migraines, strokes, and dementia. Researchers used blood tests, skin biopsies, eye exams, and brain scans to learn more about how the disease works. The goal was to better understand CADASIL, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help researchers better understand how CADASIL progresses, potentially pointing toward future treatments.
What could go wrong
This is a small, observational study with only 20 participants. It is not testing any treatment, so it will not directly lead to a cure or therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

20 people

The number who actually took part.

Started

Oct 2016

Finished

May 2022

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Male or female, age 18 to 100 years (inclusive). Established diagnosis of CADASIL, as determined by genetic testing, in early stages of disease (0-5 years after diagnosis) with mild or no cognitive impairment

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * Male or female, age 18 to 100 years (inclusive). * Established diagnosis of CADASIL, as determined by genetic testing, in early stages of disease (0-5 years after diagnosis) with mild or no cognitive impairment. * Willing and able to comply with study requirements. EXCLUSION CRITERIA: * Subjects unable to give informed consent without requirement for a legally authorized representative * Subjects who decline to provide samples for blood and/or tissue studies, or who do not consent to have samples stored for future research * Pregnant women are excluded due to study procedures (pregnancy test will be done in females of childbearing age under other NHLBI-approved protocols the subject is consented to, up to 48 hours prior to consenting to this protocol). * Subjects unable to undergo an MRI scan * Subjects who have internal non-MRI compatible metals (i.e. cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye) as these rendering an MRI unsafe * Subjects with ferromagnetic dental bridges or crowns (exclusion only for 7.0T) * Subjects unable to remain supine for the expected length of the MRI (i.e. up to 1 hour) * Subjects with uncontrolled head movements * Subjects who are claustrophobic for the expected length of the MRI (i.e. up to 1 hour) and claustrophobia cannot be controlled with anti-anxiety medication. * Subjects whose scans or examinations show unexpected brain conditions. * Subjects who do not speak English

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder cerebral arteriopathy with subcortical infarcts and leukoencephalopathy cerebral arteriopathy, autosomal dominant, with subcortical infarcts and leukoencephalopathy, type 1 stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arterial stiffness Cardiovascular disease Clinical phenotype of cadasil Germline mutation in the NOTCH 3 gene Pathogenesis of cadasil

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Nationwide Children s Hospital

    Columbus, Ohio, 43205, United States

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