Cerebral Amyloid AngiopathySENECANCT04204642
SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)
An observational study of Cerebral Amyloid Angiopathy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy
- What is being tested?
- CAA patients data collection
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 Nov 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sporadic and familial CAA patients
Who may be able to join
- 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.
Who cannot join
- evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
UOC Neurologia 5
Milan, Milano, 20133
Anna Bersano, MD, anna.bersano@istituto-besta.it
Anna Bersano, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Amyloid Angiopathy
- Being tested
- CAA patients data collection
- Medical subject headings
- Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAA patients data collectionOther
Also called Prognostic factors evaluation
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.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral amyloid angiopathy (CAA) | Cerebral amyloid angiopathy (CAA) patients Receives: Other: CAA patients data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and neuroradiological phenotype
description of the phenotypic characteristics of a large population of CAA patients collected in Italy
Measured: 24 months
Secondary outcomes (1)
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Jun 2020
- Primary completion1 May 2024
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204642
- Sponsor's protocol ID
- SENECA
- Acronym
- SENECA
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2019
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42085649Storti 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.
PubMed 40932118Storti 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.
PubMed 40626372