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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Eisai Medical Information
- Telefonnummer: +1-888-274-2378
- E-post: esi_medinfo@eisai.com
Studieorter
-
-
Alberta
-
Calgary, Alberta, Kanada
- Har inte rekryterat ännu
- University of Calgary - Hotchkiss Brain Institute
-
Edmonton, Alberta, Kanada
- Har inte rekryterat ännu
- University of Alberta, Geriatric Division
-
-
British Columbia
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Vancouver, British Columbia, Kanada
- Har inte rekryterat ännu
- University of British Columbia - CARD
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Victoria, British Columbia, Kanada
- Har inte rekryterat ännu
- UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
-
-
Ontario
-
Kingston, Ontario, Kanada
- Har inte rekryterat ännu
- Kingston HHC (Queen University)
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London, Ontario, Kanada
- Har inte rekryterat ännu
- Parkwood Hospital - London
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Mississauga, Ontario, Kanada
- Har inte rekryterat ännu
- Trillium Hospital
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Ottawa, Ontario, Kanada
- Har inte rekryterat ännu
- Bruyère Institute
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Peterborough, Ontario, Kanada
- Rekrytering
- Kawartha Center
-
Toronto, Ontario, Kanada
- Har inte rekryterat ännu
- Sunnybrook Hospital
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Toronto, Ontario, Kanada
- Rekrytering
- Toronto Memory Program
-
Toronto, Ontario, Kanada
- Har inte rekryterat ännu
- Toronto Western Hospital
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Quebec
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Gatineau, Quebec, Kanada
- Har inte rekryterat ännu
- Clinique Neuro-Outaouais
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Greenfield Park, Quebec, Kanada
- Rekrytering
- MOCA
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Montreal, Quebec, Kanada
- Har inte rekryterat ännu
- IUGM
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Montreal, Quebec, Kanada
- Har inte rekryterat ännu
- McGill University, Douglas Mental Health
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Québec, Quebec, Kanada
- Har inte rekryterat ännu
- CHU de Québec-Université Laval Research Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.
Beskrivning
Inclusion Criteria:
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada |
No intervention. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence and Severity of Known AEs
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Progression to the Next Stage of Alzheimer's Disease
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 3 years
|
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment |
Up to 3 years
|
|
Effectiveness of Risk Minimization Measures
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BAN2401-A001-506
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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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