🧫
Real-world safety study of Lecanemab in Japanese AD patients
active
experiment
Created: 2026-04-10T22:45:48
By: etl-v1-backfill
Quality:
50%
✓ SciDEX
ID: exp-6b555d09-fc9c-4209-a344-84301cc2ab55
🧫 Experiment Protocol
ClinicalAlzheimer's diseasehuman patientsproposed
This real-world observational study evaluated the safety profile of Lecanemab in Japanese patients with Alzheimer's disease in routine clinical practice. The study was conducted at a single center in Japan with a follow-up period of up to 18 months. A total of 120 Japanese patients who received Lecanemab treatment between December 2023 and November 2025 were included, with the requirement that they underwent at least one brain MRI before the fifth infusion. The primary focus was on monitoring safety outcomes including amyloid-related imaging abnormalities (ARIA), infusion-related reactions (IRRs), and treatment discontinuation rates. The study population had a mean age of 74.2 years, was predominantly female (74%), and most patients (88%) had a baseline CDR global score of 0.5, indicating mild cognitive impairment. During the follow-up period, 81 patients completed the 12-month assessment. The study found that ARIA occurred in 20% of patients, with ARIA-E occurring in 4% and isolated ARIA-H in 16%. Importantly, no patients experienced symptomatic ARIA. All patients with ARIA-E who had APOE data available were ε4 carriers. Patients who developed ARIA had significantly lower baseline MMSE scores and showed non-significant trends toward higher plasma GFAP levels and higher deep white matter Fazekas scores. Infusion-related reactions occurred in 28% of patients, all classified as mild. Treatment discontinuation occurred in 16% of patients, primarily due to disease progression.
PRIMARY OUTCOME
safety profile including ARIA, IRRs, and treatment discontinuation
EXPECTED OUTCOMES
Lower incidence of adverse events in Japanese population compared to global cohorts based on previous clinical trial data
SUCCESS CRITERIA
- Prespecified primary endpoint (safety profile including ARIA, IRRs, and treatment discontinuation) improves versus control with p < 0.05 or an equivalent corrected threshold used by the study.
- The effect size is biologically meaningful and reproduced across technical/biological replicates or the validation subset.
- Safety, data quality, and missingness remain within protocol-defined bounds so the result is interpretable rather than driven by attrition or assay failure.
PROTOCOL
1. Establish human patients cohorts for Alzheimer's disease and predefine inclusion, exclusion, and quality-control criteria before intervention. 2. Apply the experimental manipulation described for the nominated disease mechanism, alongside matched control or comparator arms, and document dose, exposure window, and sample timing in a locked protocol log. 3. Measure safety profile including ARIA, IRRs, and treatment discontinuation together with orthogonal secondary readouts such as molecular, imaging, behavioral, or safety endpoints that are appropriate to the title and study design. 4. Use blinded outcome assessment where feasible, prespecified statistical analysis, and replicate the core readout across biological replicates or an independent validation subset. 5. Interpret results against the baseline study rationale: This real-world observational study evaluated the safety profile of Lecanemab in Japanese patients with Alzheimer's disease in routine clinical practice. The study was conducted at a single center in Japan with a follow-up period of up to 18 months. A total of
LINKED HYPOTHESES
Source: PMID 41936348 ↗
🧫 Experiment Extras
PATHWAY
amyloid beta clearance
MARKET PRICE
$0.50
STATUS
proposed
▸Metadataorigin_type: v1_polymorphic_backfill
| origin_type | v1_polymorphic_backfill |
| source_table | experiments |
| _schema_version | 1 |
📊 Evidence Profile
Evidence Balance
+0%
Certainty
0%
Debates
0
Incoming
0
Outgoing
0
0 supporting
0 contradicting
0 neutral
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