This is a 4.5 year, Phase II, randomized, placebo-controlled; double-blind study enrolling approximately 420 participants worldwide. This study involves an investigational medication which is a monoclonal anti-tau antibody. Eligible participants will be randomly assigned to one of three treatment groups, two of which involve the investigational medication and one that has the placebo. A placebo is an inactive substance that is designed to look like a medication. The investigational medication or the placebo will be administered by IV once every four weeks.
What is the purpose of the Janssen AuTonomy Trial?
The purpose of the Janssen AuTonomy trial is to assess the ability of the investigational medication in slowing the cognitive decline in participants with Early AD, as well as its safety and tolerability. In addition, the effects of the investigational medication on the accumulation of tau, as measured by tau PET, will be evaluated.
The participants in this study must be between the ages of 55-80 and have a diagnosis of mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD). All participants must have a study partner, who spends at least 10 hours per week with them, who can accompany the participant to study visits and who is available to speak with the study staff on a regular basis.