A Post Authorization Registry Study of Participants Treated With LEQEMBI
ConditionAlzheimers Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEisai Limited
About this trial
To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy \[CAA\]).
The secondary purpose of this study is,
To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.
To describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).
To describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Disqualifiers
None
Trial population
The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionNo intervention.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Participants Treated With LEQEMBI1 intervention
Trial outcomes
Primary outcomes
1
Incidence and Severity of Known AEs
Incidence and severity of known AEs will be reported. AEs will include ARIA-E and ARIA-H (including asymptomatic and symptomatic) and ICH \>1 cm in diameter in participants treated with LEQEMBI.
Time frame
Up to 3 yearsSecondary outcomes
1
Time to Progression to the Next Stage of Alzheimer's Disease
Time frame
Up to 3 years2
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Incidence and severity of serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment.
Time frame
Up to 3 years3
Drug Utilization of LEQEMBI
Drug utilization will be assessed by count (n) and proportion (%) of age, ethnicity, sex, residential location, APOE4 genotype, AD diagnosis, baseline MRI findings, baseline antithrombotic use, participants prescribed LEQEMBI according to PM, and treatment discontinuation by reason.
Time frame
Up to 3 years4
Duration of Treatment
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: