AzTrials
AzTrials

Cerebral Amyloid AngiopathyPRIORITYNCT06960538

Enpowering Progression Risk of Cerebral Amyloid Angiopathy

An observational study of Cerebral Amyloid Angiopathy and CAA - Cerebral Amyloid Angiopathy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cerebral amyloid angiopathy (CAA) is a microangiopathy characterized by the progressive deposition of β-amyloid in cerebral vessel walls, contributing to intracerebral hemorrhages, cognitive decline, and other clinical manifestations. Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
1 siteItaly
Study dates
1 Nov 2021to 30 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with possible or probable CAA identified on brain MRI according to modified Boston Neuroradiological Criteria 2.0 regardless of age.

Who may be able to join

  • patients of either sex over 18 years of age;
  • patients with possible and probable symptomatic or asymptomatic CAA with or without histological demonstration (modified Boston criteria);
  • patients who have had at least one brain MRI.

Who cannot join

  • patients who have contraindications to undergoing brain MRI (e.g., pacemaker, incompatible mechanical valves, claustrophobia);
  • patients who have contraindications to or refuse to undergo lumbar puncture;
  • patients who are unable to provide informed consent for the study due to aphasic or cognitive impairment;
  • patients who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan

Other trials in Italy

About this study

Official title: PRIORITY (Enpowering Progression Risk of Cerebral Amyloid Angiopathy)

Cerebral amyloid angiopathy (CAA) is a microangiopathy characterized by the progressive deposition of β-amyloid in cerebral vessel walls, contributing to intracerebral hemorrhages, cognitive decline, and other clinical manifestations. Despite recent advances in diagnosis and understanding, many pathogenic, prognostic, and therapeutic aspects remain unclear.

Study Objective:

PRIORITY is a prospective observational study aimed at identifying clinical, neuroradiological, and biochemical biomarkers that could improve early diagnosis, risk stratification, and the identification of personalized therapeutic targets for CAA.

Read the detailed description

PRIORITY is a prospective, single-center observational study conducted at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan. It will consecutively enroll patients over 18 years of age with possible or probable cerebral amyloid angiopathy (CAA), symptomatic or asymptomatic, with or without histological confirmation. Diagnosis will follow the updated Boston criteria 2.0, and a brain MRI is mandatory for inclusion.

The study duration is 36 months, with clinical and neuroimaging assessments at baseline (T0), 12 months (T1), and 24 months (T2). CSF analysis will be performed at T0; plasma biomarkers (via ELISA and SIMOA) will be assessed at all time points. Lipid profiles will be analyzed using mass spectrometry with both untargeted and targeted lipidomic approaches (e.g., sphingolipidomics).

The comprehensive clinical and biological dataset will be used to develop a machine learning-based predictive model to support diagnostic, prognostic, and therapeutic decision-making in CAAThe study duration is 36 months, with clinical and neuroimaging assessments at baseline (T0), 12 months (T1), and 24 months (T2). CSF analysis will be performed at T0; plasma biomarkers (via ELISA and SIMOA) will be assessed at all time points. Lipid profiles will be analyzed using mass spectrometry with both untargeted and targeted lipidomic approaches (e.g., sphingolipidomics).

Keywords
Cerebral Amyloid Angiopathy, CAA, plasma biomarkers, cerebrospinal fluid biomarkers
Medical subject headings
Cerebral Amyloid Angiopathy, Cerebral Amyloid Angiopathy, Familial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Progression of CAA

    Evaluation of the natural progression of cerebral amyloid angiopathy (CAA) through clinical assessments.

    At baseline, clinical data (e.g., history of stroke, a diagnosis of dementia, presence of seizures, gait disturbances, vascular risk factors, prior brain injury/surgery, family history, medications…) recorded in a binary (yes/no) scale, indicating the presence or absence of each condition or risk factor, will be collected for each patient.

    During follow-up, new clinical events (e.g., number of new ICH-intracerebral hemorrhages, number of new ischemic stroke, presence of seizures, presence of TFNEs, cognitive status, death) will be recorded and compared with T0.

    Measured: Baseline (T0), 12 months (T1), 24 months (T2).

  2. Radiological Progression of CAA

    Evaluation of the natural progression of cerebral amyloid angiopathy (CAA) through neuroimaging markers (MRI).

    MRI assessment at baseline will include T1, T2, FLAIR, T2*, GRE, SWI, and DWI sequences. Imaging will be assessed using STRIVE (Standards for Reporting Vascular Changes on Neuroimaging) criteria, with standardized rating scales for: number of Microbleeds (Microbleed Anatomical Rating Scale - MARS); presence of Lobar ICH- intracerebral hemorrhages; presence of Superficial siderosis; presence of White matter lesions (Fazekas scale: o to 3 scores, where 0 means absence of white matter lesions and 3 large presence of them); presence of Perivascular spaces (CSO-PVS); presence of Cortical microinfarcts; presence of Global cortical atrophy; presence of Subarachnoid haemorrhage.

    Follow-up includes repeated MRI with the same sequences. MRI changes will be evaluated with the same standardized rating scales for progression or appearance of the same parameters evaluated in T0.

    Measured: Baseline (T0), 12 months (T1), 24 months (T2).

  3. Identification of Protein and Lipid Biomarkers

    Analysis of cerebrospinal fluid and plasma to identify protein (e.g., concentrations in pg/mL of total Tau, p-Tau, Aβ42/Aβ40, NfL, GFAP) and lipid (qTOF-MS) signatures associated with CAA progression.

    Measured: Baseline (T0), 12 months (T1), 24 months (T2).

Secondary outcomes (5)

  1. Cognitive Decline Assessment

    Longitudinal evaluation of cognitive functions and disability to correlate with disease progression. A neuropsychological evaluation will be performed using the Montreal Cognitive Assessment (MoCA) test, scores range from 0 to 30, with lower scores indicating greater cognitive impairment.

    Measured: Baseline (T0), 12 months (T1), 24 months (T2).

  2. Development of a Predictive Model for Disease Progression

    Development and validation of machine learning models (e.g., Random Forest, Decision Trees) to predict disease progression. Performance metrics include accuracy, sensitivity, specificity, PPV, NPV, and AUC based on integrated clinical, imaging, and biomolecular data.

    Measured: 24 months (T2).

  3. Hemorrhagic and Non-Hemorrhagic Event Incidence

    Monitoring of symptomatic and asymptomatic cerebral hemorrhages, as well as other vascular events, to determine risk factors.

    Measured: 24 months (T2)

  4. Therapeutic Target Identification

    Identification of potential molecular targets for future therapeutic interventions based on CSF and plasma biomarker analysis.

    Measured: 24 months (T2)

  5. Functional assessment

    Disability will be assessed with the modified Rankin Scale (mRS, scores ranges from 0 - no symptoms - to 6 - death).

    Measured: Baseline (T0), 12 months (T1), 24 months (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start1 Nov 2021
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06960538
Sponsor's protocol ID
PRIORITY
Acronym
PRIORITY
Status last verified
Mar 2026
First submitted
2 Apr 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pollaci G, Potenza A, Gorla G, Carrozzini T, Marinoni G, De Toma C, Canavero I, Rifino N, Boncoraglio GB, Difrancesco JC, Damavandi PT, Stanziano M, Erbetta A, Caroppo P, Di Fede G, Catania M, Zulueta A, Parati EA, Bersano A, Gatti L, Storti B. CSF and Plasma Biomarkers in Patients With Iatrogenic Cerebral Amyloid Angiopathy. Neurology. 2024 Oct 22;103(8):e209828. doi: 10.1212/WNL.0000000000209828. Epub 2024 Sep 16.

    PubMed 39284112

  • Cheng X, Su Y, Wang Q, Gao F, Ye X, Wang Y, Xia Y, Fu J, Shen Y, Al-Shahi Salman R, Dong Q. Neurofilament light chain predicts risk of recurrence in cerebral amyloid angiopathy-related intracerebral hemorrhage. Aging (Albany NY). 2020 Nov 18;12(23):23727-23738. doi: 10.18632/aging.103927. Epub 2020 Nov 18.

    PubMed 33221749

  • Wang SY, Chen W, Xu W, Li JQ, Hou XH, Ou YN, Yu JT, Tan L. Neurofilament Light Chain in Cerebrospinal Fluid and Blood as a Biomarker for Neurodegenerative Diseases: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2019;72(4):1353-1361. doi: 10.3233/JAD-190615.

    PubMed 31744001

  • Palmqvist S, Janelidze S, Stomrud E, Zetterberg H, Karl J, Zink K, Bittner T, Mattsson N, Eichenlaub U, Blennow K, Hansson O. Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease-Related beta-Amyloid Status. JAMA Neurol. 2019 Sep 1;76(9):1060-1069. doi: 10.1001/jamaneurol.2019.1632.

    PubMed 31233127

  • Gatti L, Tinelli F, Scelzo E, Arioli F, Di Fede G, Obici L, Pantoni L, Giaccone G, Caroppo P, Parati EA, Bersano A. Understanding the Pathophysiology of Cerebral Amyloid Angiopathy. Int J Mol Sci. 2020 May 13;21(10):3435. doi: 10.3390/ijms21103435.

    PubMed 32414028

  • Greenberg SM, Bacskai BJ, Hernandez-Guillamon M, Pruzin J, Sperling R, van Veluw SJ. Cerebral amyloid angiopathy and Alzheimer disease - one peptide, two pathways. Nat Rev Neurol. 2020 Jan;16(1):30-42. doi: 10.1038/s41582-019-0281-2. Epub 2019 Dec 11.

    PubMed 31827267

  • Banerjee G, Ambler G, Keshavan A, Paterson RW, Foiani MS, Toombs J, Heslegrave A, Dickson JC, Fraioli F, Groves AM, Lunn MP, Fox NC, Zetterberg H, Schott JM, Werring DJ. Cerebrospinal Fluid Biomarkers in Cerebral Amyloid Angiopathy. J Alzheimers Dis. 2020;74(4):1189-1201. doi: 10.3233/JAD-191254.

    PubMed 32176643

  • Charidimou A, Boulouis G, Frosch MP, Baron JC, Pasi M, Albucher JF, Banerjee G, Barbato C, Bonneville F, Brandner S, Calviere L, Caparros F, Casolla B, Cordonnier C, Delisle MB, Deramecourt V, Dichgans M, Gokcal E, Herms J, Hernandez-Guillamon M, Jager HR, Jaunmuktane Z, Linn J, Martinez-Ramirez S, Martinez-Saez E, Mawrin C, Montaner J, Moulin S, Olivot JM, Piazza F, Puy L, Raposo N, Rodrigues MA, Roeber S, Romero JR, Samarasekera N, Schneider JA, Schreiber S, Schreiber F, Schwall C, Smith C, Szalardy L, Varlet P, Viguier A, Wardlaw JM, Warren A, Wollenweber FA, Zedde M, van Buchem MA, Gurol ME, Viswanathan A, Al-Shahi Salman R, Smith EE, Werring DJ, Greenberg SM. The Boston criteria version 2.0 for cerebral amyloid angiopathy: a multicentre, retrospective, MRI-neuropathology diagnostic accuracy study. Lancet Neurol. 2022 Aug;21(8):714-725. doi: 10.1016/S1474-4422(22)00208-3.

    PubMed 35841910

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Amyloid Angiopathy and CAA - Cerebral Amyloid Angiopathy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Progression of CAA (time frame: Baseline (T0), 12 months (T1), 24 months (T2).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06960538, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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