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NCT Number: NCT04204642

SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UOC Neurologia 5

Milan, Milano, 20133, Italy

Location status: Recruiting

Location contact

Anna Bersano, MD

CONTACT

[email protected]

Anna Bersano, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAA patients data collection

Other

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.

Other names: Prognostic factors evaluation

Primary outcomes

  1. 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

  1. severity of the neuroradiological picture

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Bersano, MD, Phd

CONTACT

[email protected]

+39022394 ext. 2321

Renato Mantegazza, MD

CONTACT

[email protected]

+39022394 ext. 2321

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: SENECA

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Dec 19, 2019
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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