How JNJ-54861911 works
The process that leads to beta amyloid clumping starts when an enzyme cuts amyloid precursor protein into short fragments of beta amyloid. The enzyme is called enzyme beta-amyloid cleaving enzyme 1, or BACE1.
JNJ-54861911 inhibits BACE1. Janssen hopes that preventing the enzyme from generating beta amyloid will head off the formation of toxic protein clumps in the brain.
JNJ-5861911 in clinical trials
A number of clinical trials have investigated, or are still investigating, JNJ-54861911’s effectiveness and safety, and patients’ ability to tolerate it.
A Phase 1 study (NCT01887535) that began in 2013 investigated whether it was safe for healthy older people, and if they could tolerate it. The participants were divided into five groups, each receiving a different dose.
A key measure of effectiveness was whether JNJ-54861911 could lower beta amyloid levels in the cerebrospinal fluid that bathes the brain and spinal cord. Janssen discovered that it did. It presented the results at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases in 2016.
Another Phase 1 trial (NCT02360657) evaluated JNJ-54861911’s ability to lower beta amyloid levels in the cerebrospinal fluid of people at risk of Alzheimer’s but had yet to develop symptoms. It also assessed the treatment’s safety and participants’ ability to tolerate it.
Researchers randomly assigned patients to one of three groups. One received 10 mg of JNJ-54861911 once a day for up to four weeks. Another received 50 mg of JNJ-54861911, and the third a placebo. The study has been completed but no results have been published.
A Phase 2 trial (NCT02406027) has been evaluating whether JNJ-54861911 is safe for patients with early Alzheimer’s. For this study, researchers enrolled patients who had completed Phase 1b or Phase 2 clinical trials of JNJ-54861911 and wanted to continue treatment.
Janssen is conducting a Phase 2b/3 trial (NCT02569398) comparing JNJ-54861911 and a placebo’s ability to slow cognitive decline in people who are at risk of developing Alzheimer’s but have yet to develop symptoms. Researchers hope to enroll 1,650 people for the study. They are recruiting participants at 199 locations across the world. Janssen expects the study to be completed in 2024.
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