Open label, crossover, pilot study to assess the efficacy and safety of perispinal administration of etanercept (Enbrel®) in combination with nutritional supplements versus nutritional supplements alone in subjects with mild to moderate Alzheimer’s disease receiving standard care

BackgroundWhile the cause of Alzheimer’s disease (AD) remains unknown, evidence suggests it develops due to a complex series of events in the brain that occur over time. Two pathways possibly involved in development of AD are inflammation and oxidative stress. Scientists have linked chronic inflammatory events in the brain with the onset and progression of AD. Oxidative stress has also been implicated in the pathogenesis of a number of neurological disorders including AD. Tumor necrosis factor (TNF-α), a proinflammatory cytokine, has been suggested to play a role in the pathogenesis of AD. Etanercept, an immunomodulating agent approved by the FDA for the treatment of certain arthritic disorders and plaque psoriasis, binds to TNF and blocks its interaction with cell surface TNF receptors. Open label studies with small numbers of patients have reported etanercept may be beneficial for treating AD, however a recent randomized, placebo-controlled trial did not show benefit. Several nutrients have been shown t...