SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Sporadic and familial CAA patients

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • CAA patients data collection

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Cerebral amyloid angiopathy (CAA)1 intervention

Trial outcomes

Primary outcomes

1

Clinical and neuroradiological phenotype

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

Time frame
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)

Time frame
24 months

Other outcomes

Sponsors and contacts

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