PET/MRI study of amyloid burden in patients with Cerebral Amyloid Angiopathy-related inflammation

PET/MRI study of amyloid burden in patients with Cerebral Amyloid Angiopathy-related inflammation - CAA AMY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002548-10-IT

Enrollment

Registered

2021-05-24

Start date

2019-10-10

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral amyloid angiopathy related inflammation (CAA-ri) MedDRA version: 21.1 Level: PT Classification code 10068044 Term: Cerebral amyloid angiopathy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10068044 Term: Cerebral amyloid angiopathy System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Neuraceq 300MBQ/ML SOLUZIONE INIETTABILE USO ENDOVENOSO FLACONCINO (VETRO) – 1 FLACONCINO MONODOSE Product Name: Neuraceq Product Code: [18FFlorbetaben] Pharmaceutical Form: Solution for i

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: male patients; diagnosis of CAA-RI; age>55 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: Evidence of focal cerebral, physical, psychiatric or metabolic disorders that may otherwise account for the cognitive disturbances; patients with hepatic or renal insufficiency; hypersensitivity to the active substance or to any of the following excipients: ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections; wearers of pacemakers, clips or metal prostheses; contraindications to PET and MRI. This medicine contains up to 1.5 mmol sodium (ie 33 mg) per dose. This must be taken into consideration in patients on a low sodium diet. This medicine contains 15% by volume of ethanol (alcohol), that is up to 1.2 g per dose equivalent to 30 mL of beer or 12.5 mL of wine. This can be dangerous for those suffering from alcoholism, and must also be taken into consideration in high-risk groups such as patients with liver disease or epilepsy.

Design outcomes

Primary

Measure	Time frame
Main Objective: to characterize the pattern of amyloid burden in patients with cerebral amyloid angiopathy- related inflammation;Secondary Objective: to define presence and severity of cerebrovascular damage in patients with cerebral amyloid angiopathy- related inflammation; to correlate data obtained from the amyloid-PET exam with specific parameters of cerebrovascular damage;Primary end point(s): use of [18F]Florbetaben radiotracer as a biomaker to be used in the clinical field, in combination with PET, in CAA-RI;Timepoint(s) of evaluation of this end point: end of study	—

Measure

Time frame

Main Objective: to characterize the pattern of amyloid burden in patients with cerebral amyloid angiopathy- related inflammation;Secondary Objective: to define presence and severity of cerebrovascular damage in patients with cerebral amyloid angiopathy- related inflammation; to correlate data obtained from the amyloid-PET exam with specific parameters of cerebrovascular damage;Primary end point(s): use of [18F]Florbetaben radiotracer as a biomaker to be used in the clinical field, in combination with PET, in CAA-RI;Timepoint(s) of evaluation of this end point: end of study

—

Secondary

Measure	Time frame
Secondary end point(s): correlation with cerebrovascular damage for diagnostic purposes;Timepoint(s) of evaluation of this end point: end of study	—

Countries

Italy

Contacts

Public ContactUnità operativa di Medicina Nuclear

IRCCS Ospedale San Raffaele

incerti.elena@hsr.it0226432717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026