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The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in patients treated with LEQEMBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEQEMBI | Patients with alzheimer's disease treated with LEQEMBI in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from the JOY-ALZ registry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events of Special Interest (AESIs) | AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm. | Up to 6 years |
| Exposure-adjusted Incidence Rate of AESIs | AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm. | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs), Adverse drug reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs) | Up to 6 years | |
| Exposure-Adjusted Incidence Rate of AEs, ADRs, SAEs, SADRs | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with alzheimer's disease prescribed LEQEMBI based on the approved prescribing information in South Korea and clinical judgement.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eisai Korea Inc. Medical department Serena SoYoun Kwon | Contact | +82-2-3451-5533 | s-kwon@eisaikorea.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #1 | Recruiting | Nutley | New Jersey | 07110 | United States |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Incidence of AEs and ADRs That are not Reflected in the Approved Prescribing Information | Up to 6 years |
| Exposure-Adjusted Incidence Rate of AEs and ADRs That are not Reflected in the Approved Prescribing Information | Up to 6 years |
| Incidence of ARIA-Related Events by Baseline Characteristics | Baseline characteristics include APOE4 genotype status, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease treatments, and antithrombotic therapy. | Up to 6 years |
| Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics | Baseline characteristics include APOE4 genotype status, baseline MRI findings, prior Alzheimer's disease treatments, and antithrombotic therapy. | Up to 6 years |
| Incidence of AEs by Baseline Characteristics | Baseline characteristics will include age, medical history, comorbidities, and concomitant medications. | Up to 6 years |
| Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics | Baseline characteristics will include age, medical history, comorbidities, and concomitant medications. | Up to 6 years |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |