Alzheimers Disease
Conditions
Keywords
Alzheimer's Disease, Early Alzheimer's Disease, LEQEMBI, ARIA
Brief summary
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.
Detailed description
This is a noninterventional, prospective, observational Patient Registry study that will be conducted in Canada, the main purpose of which is to describe the incidence and severity of known adverse events in participants treated with LEQEMBI during routine clinical practice.
Interventions
OTHERNo Intervention
No intervention.
Sponsors
Eisai Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Known AEs | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression to the Next Stage of Alzheimer's Disease | Up to 3 years | — |
| Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice | Up to 3 years | 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. |
| Drug Utilization of LEQEMBI | Up to 3 years | 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. |
| Duration of Treatment | Up to 3 years | Drug Utilization of LEQEMBI will be assessed by Duration of Treatment |
| Effectiveness of Risk Minimization Measures | Up to 3 years | Effectiveness of Risk Minimization Measures will be assessed by the proportion of participants using antithrombotic medications during treatment, demonstrating compliance with MRI monitoring (before the 3rd, 5th, 7th, and 14th infusions), with dose suspension or discontinuation of LEQEMBI for ARIA or ICH \>1 cm, and reporting physician compliance with providing educational materials at treatment initiation and after safety updates (if applicable), including type of materials, distribution method, and quantity. |
Countries
Canada
Contacts
CONTACTEisai Medical Information
Outcome results
None listed