Phase 2 study of JNJ-63733657, an anti-tau monoclonal antibody, in participants with early Alzheimer’s disease (Autonomy)

The aim of this study is to evaluate the effect of JNJ-63733657, which is a monoclonal anti-tau antibody to prevent collection of tau in the brain by clearing it from the brain. The study will investigate whether JNJ-63733657 can slow cognitive decline in participants with Early Alzheimer’s disease with evidence of elevated brain tau (T+) and assess its safety and tolerability.

Who can be involved?

• Male or female, aged ≥55 - 80 years inclusive, at the time of informed consent
• Must be diagnosed with MCI or dementia/mild or major neurocognitive disorders
• 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

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 including Tau PET and MRI scan.

What is involved?

• Monthly visits
• 5 years trial duration
• Monthly IV injection
• Must be able to tolerate MRI and PET scans
• 33% chance of receiving placebo