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SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA) (SENECA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04204642
Recruitment Status : Not yet recruiting
First Posted : December 19, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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
Cerebral Amyloid Angiopathy 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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024


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 Name: Prognostic factors evaluation




Primary Outcome Measures :
  1. Clinical and neuroradiological phenotype [ Time Frame: 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 [ Time Frame: 24 months ]
    Evaluation of the severity of the neuroradiological picture (presence and site of WMHs, CMBs, cSS, CMIs, EPVS ,global cortical atrophy and SAH)


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


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sporadic and familial CAA patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204642


Contacts
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Contact: Anna Bersano, MD, Phd +39022394 ext 2321 anna.bersano@istituto-besta.it
Contact: Renato Mantegazza, MD +39022394 ext 2321 crc@istituto-besta.it

Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT04204642    
Other Study ID Numbers: SENECA
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn