Skip to main content
Clinical Trials/NCT04204642
NCT04204642
Recruiting
Not Applicable

SEarchiNg BiomarkErs Cerebral Amyloid Angiopathy (SENECA): Italian Network for the Study of CAA

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 site in 1 country500 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Amyloid Angiopathy
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Enrollment
500
Locations
1
Primary Endpoint
Clinical and neuroradiological phenotype
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Cerebral amyloid angiopathy (CAA) is one of the major types of cerebral small vessel disease, and a leading cause of spontaneous intracerebral hemorrhage and cognitive decline in elderly patients. Although increasingly detected, a number of aspects including the pathophysiology, the clinical and neuroradiological phenotype and the disease course are still under investigation. The incomplete knowledge of the disease limits the implementation of evidence based guidelines on patient's clinical management and the development of treatments able to prevent or reduce disease progression.

The SENECA (SEarchiNg biomarkErs of Cerebral Angiopathy) project is the first Italian multicentre cohort study aimed at better defining the disease natural history and identifying clinical and neuroradiological markers of disease progression. By a multidisciplinary approach and the collection of a large and well phenotyped series and biorepository of CAA patients, the study is ultimately expected to improve the diagnosis and the knowledge of CAA pathophysiological mechanisms.

Detailed Description

The SENECA is an Italian multicenter network integrating the experience of neurologists, neuroradiologists, neuro-ophthalmologists and biologists and allowing the standardized collection of a well-characterized wide series of sporadic and familial CAA patients.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
November 1, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All consecutive patients ≥55 years (with the exception of genetic cases), referred to the participating centres, with a diagnosis of possible probable and definite symptomatic or asymptomatic CAA, defined according to the modified Boston neuroradiological criteria, who had undergone at least one brain MRI (mandatory requirement for inclusion of the patient in the study) will be recruited.

Exclusion Criteria

  • evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding

Outcomes

Primary Outcomes

Clinical and neuroradiological phenotype

Time Frame: 24 months

description of the phenotypic characteristics of a large population of CAA patients collected in Italy

Secondary Outcomes

  • severity of the neuroradiological picture(24 months)

Study Sites (1)

Loading locations...

Similar Trials