CADASIL Registry Study

Cadasil Clinical Trial

Official title:

Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310098
• Other study ID #: MRCTA,ECFAH of FMU [2019]244-1
• Status: Recruiting
• Start date: March 9, 2020
• Est. completion date: March 9, 2049

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Lin Yi, PhD
• Phone: 13615039153
• Email: caibin929[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 9, 2049
• Est. primary completion date: March 9, 2039
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cadasil
• Dementia, Multi-Infarct

Locations

Country	Name	City	State
China	Department of Neurology , First Affiliated Hospital Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Bin Cai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall outcomes in CADASIL patients	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.	From date of enrollment until the date of death from any cause, assessed up to 20years
Secondary	The correlation of genotype and phenotype	Genotype is defined by NOTCH3 pathogenic variant position and phenotype is defined by clinical types and characteristics.	From date of enrollment until the date of death from any cause, assessed up to 20years