SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)

Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Other)
Overall Status
Recruiting
CT.gov ID
NCT04204642
Collaborator
(none)
500
1
55
9.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA): Italian Network for the Study of CAA
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical and neuroradiological phenotype [24 months]

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

    Secondary Outcome Measures

    1. severity of the neuroradiological picture [24 months]

      Evaluation of the severity of the neuroradiological picture (presence and site of WMHs, CMBs, cSS, CMIs, EPVS ,global cortical atrophy and SAH)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UOC Neurologia 5 Milano Italy 20133

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
    ClinicalTrials.gov Identifier:
    NCT04204642
    Other Study ID Numbers:
    • SENECA
    First Posted:
    Dec 19, 2019
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 9, 2020