A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Conditions

• Early Alzheimer's Disease

Eligibility Criteria

Sex

ALL

Age

50 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Lecanemab IV — DRUG
  Administered as IV infusion.
• Placebo — DRUG
  Biweekly (once every 2 weeks) administered as IVinfusion.
• Lecanemab SC — DRUG
  Administered weekly as a SC injection.

Study Details

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.

Key Dates

Start date

Mar 27, 2019

Status verified

Mar 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

1,906 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Core Study: Lecanemab 10 milligram per kilogram (mg/kg) biweekly
• Placebo Comparator: Core Study: Placebo
• Experimental: Extension Phase: Lecanemab 10 mg/kg biweekly
• Experimental: Extension Phase: Lecanemab Subcutaneous (SC) Injection Dose 1
  This will include approximately 40 de novo participants (those that did not participate in the core study) with EAD.
• Experimental: Extension Phase: Lecanemab SC Injection Dose 2
• Experimental: Extension Phase: Lecanemab SC Injection Dose 3
• Experimental: Extension Phase: Lecanemab SC Injection Dose 4
• Experimental: Extension Phase: Lecanemab 10 mg/kg IV Infusion Once Every 4 Weeks (Q4W)
• Experimental: Extension Phase B
  Participants will receive Lecanemab 10 mg/kg IV infusion Q2W, or Q4W, or Dose 3, or Dose 4, SC injection, weekly.

Primary Outcome Measure

Core Study: Change from Baseline in the CDR-SB at 18 Months [ Time Frame: Baseline, 18 months ]

Locations (112)

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