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CADASIL Registry Study

Sponsor
Bin Cai (Other)
Overall Status
Recruiting
CT.gov ID
NCT04310098
Collaborator
(none)
1,000
Enrollment
1
Location
348
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CADASIL , to optimize clinical management.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Registry Study
    Actual Study Start Date :
    Mar 9, 2020
    Anticipated Primary Completion Date :
    Mar 9, 2039
    Anticipated Study Completion Date :
    Mar 9, 2049

    Arms and Interventions

    Arm Intervention/Treatment
    CADASIL patients
    Asymptomatic carriers of CADASIL
    Relatives of CADASIL patients and carriers
    Unrelated healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. Overall outcomes in CADASIL patients [From date of enrollment until the date of death from any cause, assessed up to 20years]

      record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    Secondary Outcome Measures

    1. The correlation of genotype and phenotype [From date of enrollment until the date of death from any cause, assessed up to 20years]

      Genotype is defined by NOTCH3 pathogenic variant position and phenotype is defined by clinical types and characteristics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Sign informed consent.

    2. Age>18

    3. Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy

    4. Asymptomatic NOTCH3 mutation carriers

    5. Relatives of CADASIL patients or carriers

    6. Unrelated healthy controls

    Exclusion Criteria:

    1. Unable to cooperate with inspectors

    2. Serious systemic illness, such as heart, liver, kidney disease or major mental illness

    3. Contraindications for imaging examination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurology , First Affiliated Hospital Fujian Medical University Fuzhou Fujian China 350004

    Sponsors and Collaborators

    • Bin Cai

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bin Cai, Professor, First Affiliated Hospital of Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT04310098
    Other Study ID Numbers:
    • MRCTA,ECFAH of FMU [2019]244-1
    First Posted:
    Mar 17, 2020
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    CADASIL
    Dementia, Multi-Infarct

    Study Results

    No Results Posted as of Mar 17, 2020