SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

Cerebral Amyloid Angiopathy Clinical Trial

— SENECA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04204642
• Other study ID #: SENECA
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2020
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: Anna Bersano, MD, Phd
• Phone: +39022394
• Email: anna.bersano[@]istituto-besta.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy

Intervention

Other:
• CAA patients data collection
Demographic and clinical data of each patient, including index event that led to the diagnosis (cerebrovascular disease, dementia, gait disturbance, TFNE, seizures, headache), vascular risk factors, history of brain injury or neurosurgery, familial history, and pharmacological treatment will be collected by neurologists in charge.

Locations

Country	Name	City	State
Italy	UOC Neurologia 5	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and neuroradiological phenotype	description of the phenotypic characteristics of a large population of CAA patients collected in Italy	24 months
Secondary	severity of the neuroradiological picture	Evaluation of the severity of the neuroradiological picture (presence and site of WMHs, CMBs, cSS, CMIs, EPVS ,global cortical atrophy and SAH)	24 months