AHEAD 3-45 Study: Efficacy and safety of treatment with BAN2401 in participants with preclinical Alzheimer's disease and elevated amyloid and in participants with early preclinical Alzheimer's disease and intermediate amyloid

This is a Phase 3 study to test whether treatment with BAN2401 prevents cognitive decline and reduces brain amyloid accumulation, which is considered as one of the causes of Alzheimer’s disease. The changes in the amount of amyloid and tau in the brain will be monitored to determine the efficacy of the investigational medication.

Who can be involved?

• Male or female, aged 55 - 80 years inclusive, at the time of informed consent
• Must have risk factors for Alzheimer’s disease
• Has an identified, reliable, study partner
• If using medications to treat symptoms related to Alzheimer’s disease, doses must be stable for at least 3 months prior to screening

What is involved?

• Fortnightly / monthly visits
• 4.5 years trial duration
• Fortnightly / monthly IV injection
• Must be able to tolerate MRI and PET scans
• 50% chance of receiving placebo

Participants will be screened for the study after signing the approved informed consent form. This process takes up to 90 days. As part of the screening phase, subjects will undertake an extensive medical and neurological assessments as well as a MRI scan.