AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

Conditions

• Early Preclinical Alzheimer's Disease
• Preclinical Alzheimer's Disease

Eligibility Criteria

Sex

ALL

Age

55 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Lecanemab — DRUG
  IV infusion.
• Placebo — DRUG
  IV infusion.

Study Details

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Key Dates

Start date

Jul 14, 2020

Status verified

Jun 2026

Primary completion

Dec 21, 2028

Completion

Jan 16, 2031

Study Design

Enrollment

1,400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)
  Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216 in core study.
• Placebo Comparator: A45 Trial: Placebo (Core Study)
  Participants will receive placebo (0.9 percent \[%\] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216.
• Experimental: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)
  Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216 in core study.
• Placebo Comparator: A3 Trial: Placebo (Core Study)
  Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.
• Experimental: A3 and A45 Trial: Lecanemab 10 mg/kg (Extension Phase)
  Participants (from either A3 or A45 Trial) progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase for at least 216 weeks from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 5 mg/kg for initial 4 doses, than 10 mg/kg, administered as IV infusion, every two weeks for up to 96 weeks in extension phase.

Primary Outcome Measure

A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216 [ Time Frame: Baseline, Week 216 ]

Locations (72)

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