SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA) (SENECA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Amyloid Angiopathy
• Intervention / Treatment: Other: CAA patients data collection

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Renato Mantegazza, MD; Phone Number: 2321 +39022394; Email: crc@istituto-besta.it
• Study Contact Backup: Name: Anna Bersano, MD, Phd; Phone Number: 2321 +39022394; Email: anna.bersano@istituto-besta.it

Study Locations

• Italy
  • Milano
    • Milan, Milano, Italy, 20133
      • Recruiting
      • UOC Neurologia 5
      • Contact: Anna Bersano, MD; Email: anna.bersano@istituto-besta.it
      • Principal Investigator: Anna Bersano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sporadic and familial CAA patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cerebral amyloid angiopathy (CAA); Cerebral amyloid angiopathy (CAA) patients

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.; Other Names: Prognostic factors evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and neuroradiological phenotype	description of the phenotypic characteristics of a large population of CAA patients collected in Italy	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Proteostasis Deficiencies; Intracranial Arterial Diseases; Cerebral Arterial Diseases; Amyloidosis; Nutritional and Metabolic Diseases; Cerebral Amyloid Angiopathy
• Other Study ID Numbers: SENECA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No