SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

NCT04204642 | Recruiting

• 1 other identifier: SENECA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Amyloid Angiopathy

Outcome Measures

Primary Outcomes (1)

• Clinical and neuroradiological phenotype

  description of the phenotypic characteristics of a large population of CAA patients collected in Italy

  24 months

Secondary Outcomes (1)

• severity of the neuroradiological picture

  24 months

Study Arms (1)

Cerebral amyloid angiopathy (CAA)

Cerebral amyloid angiopathy (CAA) patients

Other: CAA patients data collection

Interventions

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.

Also known as: Prognostic factors evaluation

Cerebral amyloid angiopathy (CAA)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sporadic and familial CAA patients

You may not qualify if:

• evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding

Sponsors & Collaborators

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

Study Sites (1)

UOC Neurologia 5

Milan, Milano, 20133, Italy

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A peripheral blood withdrawal for APOE allele screening will be performed in all patients, after informed consent obtainment. Additionally, cases with early onset clinical manifestations and/or rapid clinical progression and/or relatives with a diagnosis of CAA or presenting early onset CAA clinical features will be addressed to the genetic screening of Amyloid Precursor Protein (APP) and Transthyretin (TTR) gene. A subgroup of patients will undergo at T0, T1 and T2 a whole venous blood withdrawal, to collect serum and plasma samples, evaluate the platelet concentration of Aβ40 by thioflavin T (ThT) assay and Western blot analysis and the inflammatory and endothelial profile of CAA patients by ELISA or Bio-Plex Panels

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Anna Bersano, MD, Phd

CONTACT

+39022394; anna.bersano@istituto-besta.it

Renato Mantegazza, MD

CONTACT

+39022394; crc@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: June 1, 2020
• Primary Completion: May 1, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)