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

Phase 1

• Conditions: cerebral amyloid angiopathy related inflammation (CAA-ri); MedDRA version: 21.1Level: PTClassification code 10068044Term: Cerebral amyloid angiopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002548-10-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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