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Recruiting NCT04204642

SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

— Observational Cerebral Amyloid Angiopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAA patients data collection.
Who it may be relevant to
Registry conditions: Cerebral Amyloid Angiopathy. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Clinical and neuroradiological phenotype [Time frame: 24 months]
Secondary outcome measures (1)
  • severity of the neuroradiological picture [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • UOC Neurologia 5 — Milan

Publications

  • Storti B, Capozza A, Marinoni G, Strazzabosco C, Stanziano M, Rifino N, Boncoraglio GB, Scala I, Romoli M, Paccagnella A, Canavero I, Tagliabue L, Bersano A. Amyloid PET Burden, CSF Biomarkers, and APOE Genotype in People With Iatrogenic and Sporadic Cerebral Amyloid Angiopathy. Neurology. 2026 May 26;106(10):e214949. doi: 10.1212/WNL.0000000000214949. Epub 2026 May 5. PMID 42085649
  • Storti B, Marinoni G, Cefaloni B, Francia A, Rifino N, Boncoraglio G, Indaco A, Di Fede G, Stanziano M, Canavero I, Bersano A. Cerebrospinal Fluid Biomarkers in Cerebral Amyloid Angiopathy With and Without Spontaneous Lobar Hemorrhage. J Am Heart Assoc. 2025 Sep 16;14(18):e042445. doi: 10.1161/JAHA.125.042445. Epub 2025 Sep 11. PMID 40932118
  • Storti B, Stanziano M, Marinoni G, Mazze A, Francia A, Zacarias E, Strazzabosco C, De Toma C, Rifino N, Boncoraglio G, Di Fede G, Pollaci G, Gatti L, Canavero I, Bersano A. Hippocampal Subfields Volume: Another Hint of the Continuum Between CAA and AD? Eur J Neurol. 2025 Jul;32(7):e70284. doi: 10.1111/ene.70284. PMID 40626372

Identifiers

NCT: NCT04204642 · SENECA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗