EUCTR2018-002548-10-ITActive, not recruitingPhase 1
PET/MRI study of amyloid burden in patients with Cerebral Amyloid Angiopathy-related inflammation - CAA AMY
OSPEDALE SAN RAFFAELE0 sites10 target enrollmentStarted: May 24, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
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.
Investigators
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