CADASILNCT05677880
Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) Study
An observational study of CADASIL, run by University of Wisconsin, Madison at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CADASIL
- What is being tested?
- Study Procedures
- How many people
- 660 participants
- Where
- 12 sitesUnited States
- Study dates
- 3 Jun 2022to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll a total of 500 participants with a CADASIL family history who have had a genetic test for a NOTCH3 variant. All ethnicities, sexes and ages throughout the adult lifespan will be recruited. CADASIL research participants will be recruited across the earlier part of the disease spectrum from pre-symptomatic (no symptoms or signs) through the prodromal phase (having symptoms and signs without significant functional decline) to varying levels of early dementia or mild to moderate functional impairment.
Who may be able to join
- 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
- 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
Show all 10Show fewer
- Must have a designated "study companion"
- 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
- 1. Must meet same criteria as CADASIL participants, EXCEPT have negative NOTCH3 genetic testing
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Georgia State University Research Foundation
Atlanta, Georgia, 30303
- Recruiting
Loyola University
Chicago, Illinois, 60660
- Recruiting
University of Colorado
Denver, Colorado, 80204
- Not yet recruiting
University of Texas Health Science Center
Houston, Texas, 77030
- Recruiting
University of California
Los Angeles, California, 90095
- Recruiting
Columbia University
New York, New York, 10027
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
Brown University
Providence, Rhode Island, 02912
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
- Not yet recruiting
University of Texas
San Antonio, Texas, 78249
- Recruiting
University of California
San Francisco, California, 94143
- Recruiting
University of Washington
Seattle, Washington, 98195
About this study
Official title: Unraveling the Early Phases of Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)
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.
Read the detailed description
Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) is the most common monogenic vascular dementia. Individuals with CADASIL are destined to develop vascular cognitive impairment and dementia (VCID), which can be studied in pre-symptomatic and prodromal disease stages to detect the earliest changes in biological fluids, neuroimaging, and the emerging phenotype of symptomatic VCID.
The objective of the proposed research is to exploit an autosomal dominant vascular dementia as a model to investigate specific features of VCID and to examine interactions with risk factors impacting the aging life course.
The study will enroll a total of 575 participants with a CADASIL family history who have had a genetic test for a NOTCH3 variant. Participants will complete: a clinical interview, a neurological exam, neurocognitive and behavior assessments, MRI, and a blood draw at each study visit. Participants will complete 3 in-person visits in total as part of this study: baseline, visit 2 (18 months after baseline), visit 3 (36 months after baseline). Additional contact will occur by phone, mail, email or the internet as needed and will be referred to as "remote visits".
- Conditions
- CADASIL
- Being tested
- Study Procedures
- Keywords
- neurodegeneration, dementia, cognitive impairment, NOTCH3, vascular dementia
- Medical subject headings
- CADASIL, Nerve Degeneration, Dementia, Cognitive Dysfunction, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ProceduresOther
Participants will experience
- Neurocognitive Tests and Self-Report Measures
- Clinical Interviews
- Neurological Exam
- MRI screening at baseline, 18 months, 36 months
- Fasted Blood draw
| Study group | Role | What they receive |
|---|---|---|
| Non-Carrier Cohort | About 100 participants who are at-risk, healthy family members with No NOTCH3 Mutation and no symptoms or signs of cognitive decline. Receives: Other: Study Procedures | |
| Pre-Symptomatic NOTCH3 Cohort | About 133 participants who are pre-symptomatic, at-risk, and healthy (with verified NOTCH3 mutation) family members with no symptoms. Receives: Other: Study Procedures | |
| Symptomatic NOTCH3 Cohort - No Functional Decline | About 134 participants who are symptomatic (with verified NOTCH3 mutation) family members and no functional decline (e.g., mild cognitive impairment (MCI) with premorbid functional levels maintained). Receives: Other: Study Procedures | |
| Symptomatic NOTCH3 Cohort - Functional Decline | About 133 participants who are symptomatic family members with a verified NOTCH3 CADASIL mutation and evidence of functional decline consistent with early dementia. Receives: Other: Study Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Measured by Change in Cognitive Executive Function Composite Z-Score
A composite Cognitive Executive Function Score will be reported based on data from two electronic assessments (Favorites and Match). Favorites tests both episodic and associative memory and consists of 2 learning trials followed by an immediate recall trial, 10 minute delayed recall, and delayed recognition trials. The Match assessment tests the processing speed and executive functions. The primary performance metric is the total correct score in 2 minutes. Scores are reported on a continuous scale with greater values indicating better performance. Demographically adjusted regression based z score for Favorites Total Recall and Match Total Correct are calculated to produce the composite score.
Measured: baseline and 36 months
Change in total brain volume between baseline and 36 months
MRI structural integrity is measured using available analytic packages as well as newly validated outcome measures from the investigator's imaging core. MRI outcomes will reflect changes in the total brain volume from two time points. Less volumes will reflect greater brain loss and greater change over time will suggest a more rapid rate of progression.
Measured: baseline and 36 months
Change in total cerebral spinal volume between baseline and 36 months
MRI structural integrity is measured using available analytic packages as well as newly validated outcome measures from the investigator's imaging core. MRI outcomes will reflect changes in the total cerebral spinal fluid volume from two time points. Less volumes will reflect greater brain loss and greater change over time will suggest a more rapid rate of progression.
Measured: baseline and 36 months
Percent change in brain connectivity from baseline to 36 months
MRI functional integrity is measured using available analytic packages as well as newly validated outcome measures from the investigator's imaging core. MRI outcomes will reflect the strength of connectivity among different areas of the brain. Levels of connectivity will be associated with cognitive performances. Greater connectivity is associated with better cognition.
Measured: baseline and 36 months
Change in Neurofilament Light (Nfl)
Blood will be analyzed using validated assays to measure the amount of NfL. Greater levels of NfL reflect worsened brain atrophy and change over time will demonstrate worsening over time.
Measured: baseline and 36 months
Change in World Health Organization Disability Assessment Schedule (WHODAS) Score
Functional capacity is assessed using the WHODAS instrument. The measure consists of 12 items and allows responses on a 5-point scale for each item, the total possible range of scores is converted to 0-100 where 0 is no disability and 100 is full disability. The change in total WHODAS score from baseline to 36 months will show the rate of progression in loss of capacity.
Measured: baseline and 36 months
Change in CADASIL Severity Score
CADASIL severity is determined using established disease-specific scales involving the frequency, severity, and duration of clinical signs and symptoms of CADASIL. The CADASIL scale is a 12-item scale of CADASIL symptoms and signs. Each item is given a weighted score according to a large sample of patients in Europe. A summary of all items is the total CADASIL score which can range from 0-25. Higher scores represent greater CADASIL severity. Change in total score from baseline to 36 months is used to measure the rate of symptomatic worsening or improvements over time.
Measured: baseline and 36 months
Secondary outcomes (5)
Age of Disease Onset
Date of disease onset is determined by family and medical history and self-, proxy- and clinician-reported symptoms and signs. Earlier disease onset will suggest worsened burden for the participant.
Measured: baseline
NOTCH3 variant characteristics
There are various methods used to define the NOTCH3 variations: Specific mutations are documented in available databases and hypothesis testing will include those with and without a cysteine residue and the location of variant as determined by the 34 epidermal growth factor-like repeat domains (EGFrs). Participants will gene mutations in exons 1-6 are expected to demonstrate worsened cognition, MRI abnormality, biofluid NfL marker, functional capacity and symptomatic severity than participants having gene mutation in exons 7-34.
Measured: baseline
Frequency of NOTCH2 CADASIL Genetic Variations associated with VCID
All mutations in the NOTCH3 CADASIL gene will be characterized and the frequency of each mutation will be tallied. Gene mutations that are present for the most participants will be determined.
Measured: baseline
Polygenic Risk Score (PRS)
Polygenic risk scores (PRS) for cerebral small vessel disease and dementia will be derived for each participant. We will derive PRSs for phenotypes in the data, such as worsened white matter hyperintensities or disabling headache. The best-fit PRS for each phenotype will be used to address how the PRS may impact the association of NOTCH3 canonical mutations with clinical, neuroimaging, and fluid markers of CADASIL and whether PRSs will add information to a predictive risk model to inform management of CADASIL.
Measured: baseline
Statistical Analysis of Risk Factors that Modify Clinical Meaningful Outcomes
Lifestyle risk factors for VCID (e.g., inactivity, obesity, heavy alcohol use, smoking, SES) and comorbid health conditions (e.g., hypertension, hyperlipidemia, hypercholesterolemia, atrial fibrillation, diabetes) may contribute to disease outcomes.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start3 Jun 2022
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CADASILStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jane S Paulsen, PhD, Principal investigator, University of Wisconsin, MadisonMichael D Geschwind, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677880
- Sponsor's protocol ID
- 2021-1033
- Other IDs
- 2021-6179, 1RF1AG074608-01, Protocol Version 8.0, Neurology-Gen
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All clinical research data collected as part of this study will be stored in a designated NIH database such as the National Institute on Aging Genetics of Alzheimer's Disease Data Storage Site (NIAGADS) NIA Genetic and for sharing with approved researchers worldwide. Summaries of studies and the contents of measured variables as well as original study document text are generally available to the public, while access to individual-level data including phenotypic data tables and genotypes require varying levels of authorization. Data to be de-identified such that the identities of data subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users.
Publications
Caruso MR, Fischer BL, Adams WH, Burks DK, Le B, Salardini A, Majersik JJ, Salloway SP, Elliott JL, Bockholt HJ, Jayadev S, Geschwind MD, Biller J, Lutsep HL, Doyle SJ, Hinman JD, Liebeskind DS, Naqvi IA, Eklund K, Seshadri S, Krishnamurthy LC, Fornage M, Paulsen JS, Huey ED; United States CADASIL Consortium. Neuropsychiatric Symptom Associations with NOTCH3 Genotype in the United States CADASIL Consortium. medRxiv [Preprint]. 2026 Sep 30:2026.09.24.26363718. doi: 10.64898/2026.09.24.26363718.
PubMed 42856679
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Early Phases of Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)
- ClinicalTrials.gov ID
- NCT05677880
- Acronym / sponsor ID
- 2021-1033
- Conditions
- CADASIL
- Keywords
- neurodegeneration, dementia, cognitive impairment, NOTCH3, vascular dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) is the most common monogenic vascular dementia. Individuals with CADASIL are destined to develop vascular cognitive impairment and dementia (VCID), which can be studied in pre-symptomatic and prodromal disease stages to detect the earliest changes in biological fluids, neuroimaging, and the emerging phenotype of symptomatic VCID.
The objective of the proposed research is to exploit an autosomal dominant vascular dementia as a model to investigate specific features of VCID and to examine interactions with risk factors impacting the aging life course.
The study will enroll a total of 575 participants with a CADASIL family history who have had a genetic test for a NOTCH3 variant. Participants will complete: a clinical interview, a neurological exam, neurocognitive and behavior assessments, MRI, and a blood draw at each study visit. Participants will complete 3 in-person visits in total as part of this study: baseline, visit 2 (18 months after baseline), visit 3 (36 months after baseline). Additional contact will occur by phone, mail, email or the internet as needed and will be referred to as "remote visits".
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Carrier Cohort | – | Other: Study ProceduresAbout 100 participants who are at-risk, healthy family members with No NOTCH3 Mutation and no symptoms or signs of cognitive decline. |
| Pre-Symptomatic NOTCH3 Cohort | – | Other: Study ProceduresAbout 133 participants who are pre-symptomatic, at-risk, and healthy (with verified NOTCH3 mutation) family members with no symptoms. |
| Symptomatic NOTCH3 Cohort - No Functional Decline | – | Other: Study ProceduresAbout 134 participants who are symptomatic (with verified NOTCH3 mutation) family members and no functional decline (e.g., mild cognitive impairment (MCI) with premorbid functional levels maintained). |
| Symptomatic NOTCH3 Cohort - Functional Decline | – | Other: Study ProceduresAbout 133 participants who are symptomatic family members with a verified NOTCH3 CADASIL mutation and evidence of functional decline consistent with early dementia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll a total of 500 participants with a CADASIL family history who have had a genetic test for a NOTCH3 variant. All ethnicities, sexes and ages throughout the adult lifespan will be recruited. CADASIL research participants will be recruited across the earlier part of the disease spectrum from pre-symptomatic (no symptoms or signs) through the prodromal phase (having symptoms and signs without significant functional decline) to varying levels of early dementia or mild to moderate functional impairment.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study ProceduresParticipants will experience * Neurocognitive Tests and Self-Report Measures * Clinical Interviews * Neurological Exam * MRI screening at baseline, 18 months, 36 months * Fasted Blood draw | Other | Non-Carrier Cohort, Pre-Symptomatic NOTCH3 Cohort, Symptomatic NOTCH3 Cohort - Functional Decline, Symptomatic NOTCH3 Cohort - No Functional Decline |
Primary outcome
Performance Measured by Change in Cognitive Executive Function Composite Z-Score
Time frame: baseline and 36 months
A composite Cognitive Executive Function Score will be reported based on data from two electronic assessments (Favorites and Match). Favorites tests both episodic and associative memory and consists of 2 learning trials followed by an immediate recall trial, 10 minute delayed recall, and delayed recognition trials. The Match assessment tests the processing speed and executive functions. The primary performance metric is the total correct score in 2 minutes. Scores are reported on a continuous scale with greater values indicating better performance. Demographically adjusted regression based z score for Favorites Total Recall and Match Total Correct are calculated to produce the composite score.
Change in total brain volume between baseline and 36 months
Time frame: baseline and 36 months
MRI structural integrity is measured using available analytic packages as well as newly validated outcome measures from the investigator's imaging core. MRI outcomes will reflect changes in the total brain volume from two time points. Less volumes will reflect greater brain loss and greater change over time will suggest a more rapid rate of progression.
Change in total cerebral spinal volume between baseline and 36 months
Time frame: baseline and 36 months
MRI structural integrity is measured using available analytic packages as well as newly validated outcome measures from the investigator's imaging core. MRI outcomes will reflect changes in the total cerebral spinal fluid volume from two time points. Less volumes will reflect greater brain loss and greater change over time will suggest a more rapid rate of progression.
Percent change in brain connectivity from baseline to 36 months
Time frame: baseline and 36 months
MRI functional integrity is measured using available analytic packages as well as newly validated outcome measures from the investigator's imaging core. MRI outcomes will reflect the strength of connectivity among different areas of the brain. Levels of connectivity will be associated with cognitive performances. Greater connectivity is associated with better cognition.
Change in Neurofilament Light (Nfl)
Time frame: baseline and 36 months
Blood will be analyzed using validated assays to measure the amount of NfL. Greater levels of NfL reflect worsened brain atrophy and change over time will demonstrate worsening over time.
Change in World Health Organization Disability Assessment Schedule (WHODAS) Score
Time frame: baseline and 36 months
Functional capacity is assessed using the WHODAS instrument. The measure consists of 12 items and allows responses on a 5-point scale for each item, the total possible range of scores is converted to 0-100 where 0 is no disability and 100 is full disability. The change in total WHODAS score from baseline to 36 months will show the rate of progression in loss of capacity.
Change in CADASIL Severity Score
Time frame: baseline and 36 months
CADASIL severity is determined using established disease-specific scales involving the frequency, severity, and duration of clinical signs and symptoms of CADASIL. The CADASIL scale is a 12-item scale of CADASIL symptoms and signs. Each item is given a weighted score according to a large sample of patients in Europe. A summary of all items is the total CADASIL score which can range from 0-25. Higher scores represent greater CADASIL severity. Change in total score from baseline to 36 months is used to measure the rate of symptomatic worsening or improvements over time.
5 secondary outcomes
Age of Disease Onset
Time frame: baseline
NOTCH3 variant characteristics
Time frame: baseline
Frequency of NOTCH2 CADASIL Genetic Variations associated with VCID
Time frame: baseline
Polygenic Risk Score (PRS)
Time frame: baseline
Statistical Analysis of Risk Factors that Modify Clinical Meaningful Outcomes
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 42856679Caruso MR, Fischer BL, Adams WH, Burks DK, Le B, Salardini A, Majersik JJ, Salloway SP, Elliott JL, Bockholt HJ, Jayadev S, Geschwind MD, Biller J, Lutsep HL, Doyle SJ, Hinman JD, Liebeskind DS, Naqvi IA, Eklund K, Seshadri S, Krishnamurthy LC, Fornage M, Paulsen JS, Huey ED; United States CADASIL Consortium. Neuropsychiatric Symptom Associations with NOTCH3 Genotype in the United States CADASIL Consortium. medRxiv [Preprint]. 2026 Sep 30:2026.09.24.26363718. doi: 10.64898/2026.09.24.26363718.
- Registry for CADASILLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All clinical research data collected as part of this study will be stored in a designated NIH database such as the National Institute on Aging Genetics of Alzheimer's Disease Data Storage Site (NIAGADS) NIA Genetic and for sharing with approved researchers worldwide. Summaries of studies and the contents of measured variables as well as original study document text are generally available to the public, while access to individual-level data including phenotypic data tables and genotypes require varying levels of authorization. Data to be de-identified such that the identities of data subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane S Paulsen, PhD principal investigator
University of Wisconsin, Madison
Michael D Geschwind, MD principal investigator
University of California, San Francisco
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CADASIL, run by University of Wisconsin, Madison at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cadasil Consortium (1-833-795-3016, info@cadasil-consortium.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Measured by Change in Cognitive Executive Function Composite Z-Score (time frame: baseline and 36 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.