Alzheimer’s disease (AD) is an irreversible, progressive brain disorder that impacts memory function and cognitive skills.
JNJ-63733657 has been developed for the potential treatment of AD, primarily for the possible prevention or slowing of cognitive decline.
JNJ-63733657 is a monoclonal antibody that recognises and binds to the tau protein. Tau proteins in the brains of people with Alzheimer’s disease are misfolded and abnormally shaped. Alzheimer’s disease is well known to feature neurofibrillary tangles that are composed of modified tau protein. Tau proteins also exist in smaller versions, and these smaller forms of tau circulate among the brain cells in people with AD, interfering with cellular function. They are found in brains that are developing AD decades before the disease can be clinically diagnosed. It is thought that JNJ-63733657 may help prevent the spread and progression of cell damage due to tau, by interacting and counteracting its effects, which possibly may lead to a reduction of tau build up in the brain in some people with AD.
This study medication is formulated as an IV infusion. To compare how well this drug works, patients will randomly be assigned to 3 different groups: 1 of 2 dosages of JNJ-63733657 (1000 or 3000 mg) or placebo at a ratio of 1:1:1. Therefore, all participants have a 2 in 3 chance of receiving the active study drug.
Following a screening period of up to 90 days, this study will require participation for up to 4.5 years, including on-site visits every month during that period.
Main Inclusion criteria*:
- 55 to 80 years of age
- Early AD: Gradual and progressive decline in cognition over at least the past 6 months
- Availability of a designated study partner
- If receiving medication for symptomatic AD, have a stable dosing regimen for at least 2 months prior screening
*Please note that there are additional criteria that must be met in order to qualify to participate in this study.