Post-marketing surveillance of AMYViD Injection

JRCT ID: jRCT2031220067

Registered date:17/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Visualization of amyloid beta plaque in the brain of patients with cognitive dysfunction suspected o
• Date of first enrollment: 03/03/2020
• Target sample size: 500
• Study type: Observational

Outcome(s)

Primary Outcome

Collect adverse events of AMYViD and confirm its safety.
- Unknown adverse drug reactions (particularly important adverse drug reactions)
- Factors that may affect safety, efficacy, etc.
- Status of adverse drug reactions under actual use of drugs

• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who received AMYViD Injection during the enrollment period of this study.
• Exclude criteria: Patients who enrolled in other clinical studies or clinical trials during the enrollment period of this study.

Related Information

• Primary Sponsor: Kazunori Bando