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To determine whether the tumor necrosis factor α inhibitor etanercept is well tolerated and obtain preliminary data on its safety in Alzheimer disease dementia.In a double-blind study, patients with mild to moderate Alzheimer disease dementia were randomized (1:1) to subcutaneous etanercept (50 mg) once weekly or identical placebo over a 24-week period. Tolerability and safety of this medication was recorded including secondary outcomes of cognition, global function, behavior, and systemic cytokine levels at baseline, 12 weeks, 24 weeks, and following a 4-week washout period. This trial is registered with EudraCT (2009-013400-31) and ClinicalTrials.gov (NCT01068353).Forty-one participants (mean age 72.4 years; 61% men) were randomized to etanercept (n = 20) or placebo (n = 21). Etanercept was well tolerated; 90% of participants (18/20) completed the study compared with 71% (15/21) in the placebo group. Although infections were more common in the etanercept group, there were no serious adverse events or new safety concerns. While there were some interesting trends that favored etanercept, there were no statistically significant changes in cognition, behavior, or global function.This study showed that subcutaneous etanercept (50 mg/wk) was well tolerated in this small group of patients with Alzheimer disease dementia, but a larger more heterogeneous group needs to be tested before recommending its use for broader groups of patients.This study shows Class I evidence that weekly subcutaneous etanercept is well tolerated in Alzheimer disease dementia.

Original publication

DOI

10.1212/wnl.0000000000001617

Type

Journal article

Journal

Neurology

Publication Date

05/2015

Volume

84

Pages

2161 - 2168

Addresses

From the Faculty of Medicine, Clinical Experimental Sciences (J.B., L.B., D.C., C.H.), and Faculty of Natural and Environmental Science, Centre for Biological Sciences (J.T., U.P., V.H.P.), University of Southampton; Memory Assessment and Research Centre (J.B., L.B., V.H., R.S., S.S., C.H.), Moorgreen Hospital, Southern Health Foundation Trust, Southampton; Becton Health Centre (B.M.), Southern Health Foundation Trust, New Milton; Centre for Public Health (P.P.), Queens University Belfast; MRC Centre for Neuropsychiatric Genetics and Genomics (R.R., R.T.), Institute of Psychological Medicine and Clinical Neurosciences, Cardiff University, UK.

Keywords

Humans, Alzheimer Disease, Tumor Necrosis Factor-alpha, Immunoglobulin G, Receptors, Tumor Necrosis Factor, Anti-Inflammatory Agents, Non-Steroidal, Treatment Outcome, Injections, Subcutaneous, Double-Blind Method, Aged, Female, Male, Etanercept