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SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04204642
Acronym
SENECA
Enrollment
500
Registered
2019-12-19
Start date
2020-06-01
Completion date
2027-11-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Amyloid Angiopathy

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.

Interventions

OTHERCAA 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.

Sponsors

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical and neuroradiological phenotype24 monthsdescription of the phenotypic characteristics of a large population of CAA patients collected in Italy

Secondary

MeasureTime frameDescription
severity of the neuroradiological picture24 monthsEvaluation of the severity of the neuroradiological picture (presence and site of WMHs, CMBs, cSS, CMIs, EPVS ,global cortical atrophy and SAH)

Countries

Italy

Contacts

CONTACTAnna Bersano, MD, Phd
anna.bersano@istituto-besta.it+39022394
CONTACTRenato Mantegazza, MD
crc@istituto-besta.it+39022394

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026