Scientists are looking at whether Etanercept, an anti-inflammatory agent approved for treating arthritis, can also reduce the symptoms of Alzheimer’s disease.
As an arthritis therapy, it is marketed under the brand name Enbrel.
How etanercept works
Alzheimer’s patients have higher than normal levels of a pro-inflammatory cytokine, or protein, known as tumor necrosis factor alpha (TNF-α). The substance plays a role in signaling in the brain.
Increased levels of it can trigger continuous immune system activation, which can lead to brain tissue inflammation and eventually nerve cell death.
Higher levels of TNF-α have been associated with a much faster rate of decline in Alzheimer’s patients’ cognitive ability — thinking, learning, and memory.
Etanercept works by binding to TNF-α. This inhibits the signaling process and prevents over-activation of the immune system.
Etanercept in clinical trials
The possibility that etanercept could treat Alzheimer’s was initially assessed in a small open-label pilot study that was not placebo-controlled. The study suggested that etanercept could slow decline in cognitive ability.
After the pilot study, British researchers conducted a double-blind, placebo-controlled Phase 2 clinical trial (NCT01068353) of etanercept’s impact on Alzheimer’s patients. The 41 participants were randomized to receive either injected etanercept or a placebo once a week for 24 weeks.
The main objectives of the trial were to see whether etanercept was safe and if patients could tolerate it. Researchers also assessed whether the treatment would improve patients’ cognition, affect their behavior, and lower their TNF- α levels after 12 and 24 weeks.
The results of the study, published in the journal Neurology, showed that patients tolerated etanercept well. A key sign of that was that more participants treated with etanercept completed the trial, compared with those on the placebo.
Unfortunately, researchers found no significant changes in Alzheimer’s symptoms between the treated and control groups. They concluded that additional studies were needed to assess etanercept as an Alzheimer’s treatment. The said those studies should involve a larger, more closely matched group — such as patients at a similar stage of Alzheimer’s.
Because etanercept affects the immune system, its use can lead to severe infections, such as tuberculosis; other bacterial infections, including Legionella and Listeria; viral infections; and invasive fungal infections.
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