ARIA-H

Eisai: Additional Detailed Analyses from Phase 2 Study 201 of Lecanemab Published as Three Papers in Peer-Reviewed Journals

Retrieved on: 
Friday, March 31, 2023
Apolipoprotein E, Alzheimer's disease, Lecanemab, BIIB, PET, Horseshoe kidney, Cmax, Biomarker, MCI, Plasma, Eisai, Incidence, ARIA, ARIA-H, Amyloid, Amyloid-related imaging abnormalities, Patient, Co-promotion, Intracerebral hemorrhage, ADAS, Research, AD, Phase, OLE, Safety, Pharmaceutical industry, Medical imaging, Biogen, Dementia

Consistency of efficacy results across various clinical measures and statistical methods in Study 201: Alzheimer's Research and Therapy

Key Points: 
  • Consistency of efficacy results across various clinical measures and statistical methods in Study 201: Alzheimer's Research and Therapy
    3.
  • ARIA (amyloid-related imaging abnormality) profile in Study 201: Alzheimer's & Dementia: Translational Research and Clinical Interventions
    Study 201 was a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD.
  • ARIA-H events in the OLE were generally consistent with the rate seen in the lecanemab 10 mg/kg biweekly group in the core study.
  • Based on the fact that lecanemab was generally well tolerated at the highest dose in this study, the Phase 3 Clarity AD study was conducted without dose titration.

EISAI PRESENTED NEW ANALYSES OF ARIA AND QOL ON LECANEMAB IN CLARITY AD AT THE AD/PD™ 2023 ANNUAL MEETING

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Disease, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Incidence, QOL, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, 2023 International Conference on Climate Resilient Pakistan, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity, Eisai

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer's Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, Edema, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Eisai, QOL, Incidence, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer’s Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Additional Detailed Analyses From Phase 2 Study 201 of Lecanemab Published as Three Papers in Peer-Reviewed Journals

Retrieved on: 
Friday, March 31, 2023
Apolipoprotein E, Alzheimer's disease, Lecanemab, BIIB, PET, Horseshoe kidney, Brain, Cmax, Biomarker, MCI, Dose, Plasma, Eisai, Incidence, ARIA, ARIA-H, Amyloid, Amyloid-related imaging abnormalities, Patient, Headquarters, Corporation, Co-promotion, Intracerebral hemorrhage, ADAS, Research, AD, Phase, OLE, Safety, Medical imaging, Pharmaceutical industry, Biogen, Dementia

Detailed results on biomarker, cognitive, and clinical effects from Study 201.

Key Points: 
  • Detailed results on biomarker, cognitive, and clinical effects from Study 201.
  • The sensitivity analysis showed that 18 months of lecanemab treatment consistently reduced the clinical decline in all statistical models examined.
  • ARIA-H events in the OLE were generally consistent with the rate seen in the lecanemab 10 mg/kg biweekly group in the core study.
  • Based on the fact that lecanemab was generally well tolerated at the highest dose in this study, the Phase 3 Clarity AD study was conducted without dose titration.