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Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial.

Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial.
Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial.
Objectives: To determine whether the tumor necrosis factor ? inhibitor etanercept is well tolerated and obtain preliminary data on its safety in Alzheimer disease dementia.

Methods: 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).

Results: 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.

Conclusions: 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.

Classification of evidence: This study shows Class I evidence that weekly subcutaneous etanercept is well tolerated in Alzheimer disease dementia.
0028-3878
2161-2168
Butchart, Joseph
f5e66a87-26f6-4679-9fad-34141c132acf
Brook, Laura
ac5421a0-5eb1-4709-a07f-ad1bd1725e3a
Hopkins, Vivienne
20f9cb08-6c50-4c73-902f-707934ffdc43
Teeling, Jessica
fcde1c8e-e5f8-4747-9f3a-6bdb5cd87d0a
Puntener, Ursula
6209ac61-20b4-41c0-8339-fa22742334a3
Sharples, Richard
ca441da0-f3b3-4d57-ab42-3b3dfe070a56
Sharif, Saif
43ce459a-cfcf-492d-85a2-83b3d69abb15
McFarlane, Brady
e65d6960-01e9-44fb-947a-a0f963c88376
Raybould, Rachel
e50082d7-12bb-4e64-8cc7-0a3ec3e71431
Thomas, Rhodri
f53e5e89-7652-4fb8-be75-0c3894f38846
Passmore, Peter
175afd4d-532f-4340-b40b-ce5f4b7e8945
Perry, V. Hugh
8f29d36a-8e1f-4082-8700-09483bbaeae4
Holmes, Clive
ada5abf3-8459-4cf7-be40-3f4e9391cc96
Butchart, Joseph
f5e66a87-26f6-4679-9fad-34141c132acf
Brook, Laura
ac5421a0-5eb1-4709-a07f-ad1bd1725e3a
Hopkins, Vivienne
20f9cb08-6c50-4c73-902f-707934ffdc43
Teeling, Jessica
fcde1c8e-e5f8-4747-9f3a-6bdb5cd87d0a
Puntener, Ursula
6209ac61-20b4-41c0-8339-fa22742334a3
Sharples, Richard
ca441da0-f3b3-4d57-ab42-3b3dfe070a56
Sharif, Saif
43ce459a-cfcf-492d-85a2-83b3d69abb15
McFarlane, Brady
e65d6960-01e9-44fb-947a-a0f963c88376
Raybould, Rachel
e50082d7-12bb-4e64-8cc7-0a3ec3e71431
Thomas, Rhodri
f53e5e89-7652-4fb8-be75-0c3894f38846
Passmore, Peter
175afd4d-532f-4340-b40b-ce5f4b7e8945
Perry, V. Hugh
8f29d36a-8e1f-4082-8700-09483bbaeae4
Holmes, Clive
ada5abf3-8459-4cf7-be40-3f4e9391cc96

Butchart, Joseph, Brook, Laura, Hopkins, Vivienne, Teeling, Jessica, Puntener, Ursula, Sharples, Richard, Sharif, Saif, McFarlane, Brady, Raybould, Rachel, Thomas, Rhodri, Passmore, Peter, Perry, V. Hugh and Holmes, Clive (2015) Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial. Neurology, 84 (21), 2161-2168. (doi:10.1212/WNL.0000000000001617). (PMID:25934853)

Record type: Article

Abstract

Objectives: To determine whether the tumor necrosis factor ? inhibitor etanercept is well tolerated and obtain preliminary data on its safety in Alzheimer disease dementia.

Methods: 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).

Results: 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.

Conclusions: 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.

Classification of evidence: This study shows Class I evidence that weekly subcutaneous etanercept is well tolerated in Alzheimer disease dementia.

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More information

e-pub ahead of print date: 1 May 2015
Published date: 26 May 2015
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 395340
URI: https://eprints.soton.ac.uk/id/eprint/395340
ISSN: 0028-3878
PURE UUID: eb7f70cc-4099-4716-ae89-2411d151c0d8
ORCID for Clive Holmes: ORCID iD orcid.org/0000-0003-1999-6912

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Date deposited: 27 May 2016 11:00
Last modified: 20 Feb 2019 01:36

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Contributors

Author: Joseph Butchart
Author: Laura Brook
Author: Vivienne Hopkins
Author: Jessica Teeling
Author: Ursula Puntener
Author: Richard Sharples
Author: Saif Sharif
Author: Brady McFarlane
Author: Rachel Raybould
Author: Rhodri Thomas
Author: Peter Passmore
Author: V. Hugh Perry
Author: Clive Holmes ORCID iD

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