A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab
ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEisai Co., Ltd.
About this trial
The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All participants who are treated with lecanemab in routine clinical practice
Disqualifiers
None
Trial population
Participants prescribed lecanemab by a physician in routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionThis is a non-interventional study.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)
Time frame
Up to 156 weeks2
Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA
Time frame
Up to 156 weeksSecondary outcomes
1
Number of Participants With Infusion Related Reaction
Time frame
Up to 156 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov