A Post Authorization Registry Study of Participants Treated With LEQEMBI
Post Authorization Registry Study of Patients Treated With LEQEMBI
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eisai Medical Information
- Numéro de téléphone: +1-888-274-2378
- E-mail: esi_medinfo@eisai.com
Lieux d'étude
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Alberta
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Calgary, Alberta, Canada
- Pas encore de recrutement
- University of Calgary - Hotchkiss Brain Institute
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Edmonton, Alberta, Canada
- Pas encore de recrutement
- University of Alberta, Geriatric Division
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British Columbia
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Vancouver, British Columbia, Canada
- Pas encore de recrutement
- University of British Columbia - CARD
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Victoria, British Columbia, Canada
- Pas encore de recrutement
- UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
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Ontario
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Kingston, Ontario, Canada
- Pas encore de recrutement
- Kingston HHC (Queen University)
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London, Ontario, Canada
- Pas encore de recrutement
- Parkwood Hospital - London
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Mississauga, Ontario, Canada
- Pas encore de recrutement
- Trillium Hospital
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Ottawa, Ontario, Canada
- Pas encore de recrutement
- Bruyère Institute
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Peterborough, Ontario, Canada
- Recrutement
- Kawartha Center
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Toronto, Ontario, Canada
- Pas encore de recrutement
- Sunnybrook Hospital
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Toronto, Ontario, Canada
- Recrutement
- Toronto Memory Program
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Toronto, Ontario, Canada
- Pas encore de recrutement
- Toronto Western Hospital
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Quebec
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Gatineau, Quebec, Canada
- Pas encore de recrutement
- Clinique Neuro-Outaouais
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Greenfield Park, Quebec, Canada
- Recrutement
- MOCA
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Montreal, Quebec, Canada
- Pas encore de recrutement
- IUGM
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Montreal, Quebec, Canada
- Pas encore de recrutement
- McGill University, Douglas Mental Health
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Québec, Quebec, Canada
- Pas encore de recrutement
- CHU de Québec-Université Laval Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.
La description
Inclusion Criteria:
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada |
No intervention. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence and Severity of Known AEs
Délai: 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. |
Up to 3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Progression to the Next Stage of Alzheimer's Disease
Délai: Up to 3 years
|
Up to 3 years
|
|
|
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Délai: 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. |
Up to 3 years
|
|
Drug Utilization of LEQEMBI
Délai: Up to 3 years
|
Drug utilization will be assessed by count (n) and proportion (%) of age group, 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. |
Up to 3 years
|
|
Duration of Treatment
Délai: Up to 3 years
|
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment |
Up to 3 years
|
|
Effectiveness of Risk Minimization Measures
Délai: 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. |
Up to 3 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BAN2401-A001-506
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Informations sur les médicaments et les dispositifs, documents d'étude
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