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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Eisai Medical Information
- Telefonnummer: +1-888-274-2378
- E-post: esi_medinfo@eisai.com
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- University of British Columbia - CARD
-
Victoria, British Columbia, Canada
- UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
-
-
Ontario
-
London, Ontario, Canada
- Parkwood Hospital - London
-
Mississauga, Ontario, Canada
- Trillium Hospital
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Ottawa, Ontario, Canada
- Bruyère Institute
-
Peterborough, Ontario, Canada
- Kawartha Center
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Toronto, Ontario, Canada
- Toronto Memory Program
-
Toronto, Ontario, Canada
- Toronto Western Hospital
-
Toronto, Ontario, Canada
- Sunnybrook Hospital
-
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Quebec
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Montreal, Quebec, Canada
- McGill University, Douglas Mental Health
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Québec, Quebec, Canada
- CHU de Québec-Université Laval Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada
|
Ingen intervensjon.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and Severity of Known AEs
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Progression to the Next Stage of Alzheimer's Disease
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Up to 3 years
|
|
Duration of Treatment
Tidsramme: Up to 3 years
|
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
|
Up to 3 years
|
|
Effectiveness of Risk Minimization Measures
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BAN2401-A001-506
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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