AHEAD 3-45 (H-48340)

A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment with BAN2401 in Subjects with Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects with Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)

This study will test whether the anti-amyloid drug, lecanemab, will prevent cognitive decline and amyloid plaque development compared to placebo.

Inclusion criteria:

• Cognitively normal between 55-80 (inclusive); subjective memory complaints are okay, but no diagnosis of MCI or dementia
• Available for infusions every 2 or 4 weeks for 4 years, in addition to periodic safety MRIs every ~3 months
• Has a study partner that can attest to their memory and independent functioning

Exclusion criteria:

• Current or recent history of stroke, TIA, seizure, cancer (except skin or prostate cancer in situ), substance abuse or dependence, major psychiatric or neurological disorder, autoimmune disorder that requires immunosuppressants, bleeding disorder, HIV
• Current use of immunosuppressants and/or monoclonal antibody treatment
• Severe visual or hearing impairments that would prevent valid performance on cognitive testing
• Contraindications to 3T MRI