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An Observational Study of LEQEMBI in Routine Clinical Practice in Taiwan

ConditionAlzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEisai Taiwan Inc.

About this trial

The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit (ARIA-H), intracerebral hemorrhage greater than 1 cm, and anaphylaxis (stratified by apolipoprotein E4 variant \[APOE4\] genotype, concomitant antithrombotic therapy, and comorbid cerebral amyloid angiopathy \[CAA\]), in participants treated with LEQEMBI in routine clinical practice in Taiwan.

To describe previously unknown adverse events related to long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.

To describe progression to the next stage of Alzheimer's Disease (AD) in routine clinical practice.

To describe drug utilization of LEQEMBI and effectiveness of risk minimization measures in routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan.

Participants who have been prescribed LEQEMBI and who consent to enroll in the program.

Disqualifiers

None

Trial population

The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan and are enrolled into the PASS Registry either prior to initiation or after beginning of therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    This is a non-interventional study.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Incidence and Severity of Known Adverse Events (AEs)

Time frame
Up to 2 years

Secondary outcomes

1

Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice

Incidence and severity of serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.

Time frame
Up to 2 years
2

Time to Progression to the Next Stage of Alzheimer's Disease

The stages of disease are assessed by the clinician using tools that they use in routine clinical practice, and are mild cognitive impairment (MCI) due to AD, mild AD, moderate AD, or severe AD.

Time frame
Up to 2 years
3

Drug Utilization of LEQEMBI

Drug utilization will be assessed by baseline demographics, apolipoprotein E4 variant (APOE4) genotype, AD diagnosis, and baseline magnetic resonance imaging (MRI) findings, baseline antithrombotic use.

Time frame
Up to 2 years
4

Duration of Treatment

Drug Utilization of LEQEMBI will be assessed by Duration of Treatment

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisai Taiwan Inc.

Lead sponsor

Source ClinicalTrials.gov

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