A Postmarketing Study of LEQEMBI in United Kingdom (UK) Participants With Alzheimer's Disease (AD)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEisai Limited

About this trial

The primary purpose of the study is to describe the incidence and severity of known adverse events (AEs), including Amyloid-Related Imaging Abnormalities Oedema/Effusion (ARIA-E), Amyloid-Related Imaging Abnormalities-Microhemorrhage and Haemosiderin Deposit (ARIA-H), intracerebral hemorrhage greater than (\>) 1 centimeter (cm) in diameter, and anaphylaxis (stratified by apolipoprotein E4 variant \[APOE4\] genotype, concomitant antithrombotic therapy, and comorbid Cerebral Amyloid Angiopathy \[CAA\]), of LEQEMBI in routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant (and/or legally authorised representative) has provided written informed consent to participate in the Post-Authorisation Safety Study (PASS) and for use of their protected health information (PHI).

The participant is registered in the Controlled Access Programme (CAP) and has been prescribed LEQEMBI.

Disqualifiers

None

Trial population

Participants with AD who are prescribed LEQEMBI by a physician in routine clinical practice in the UK.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    No intervention.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Participants Treated With LEQEMBI1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis

Time frame
Up to 3 years

Secondary outcomes

1

Time to Progression to the Next Stage of Alzheimer's Disease (AD)

Time frame
Up to 3 years
2

Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment

Time frame
Up to 3 years
3

Drug Utilisation of LEQEMBI Based on Baseline Characteristics

Baseline demographics will include age/age group, sex, race, ethnicity, clinical disease stage, APOE4 genotypes, diagnosis of AD, baseline magnetic resonance imaging (MRI) findings consistent with a high risk of cerebral amyloid angiopathy (CAA), use of AD treatment, and use of concomitant antithrombotic medications at baseline.

Time frame
Up to 3 years
4

Duration of Treatment

Drug Utilization of LEQEMBI will be assessed by Duration of Treatment

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: