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Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial
Butchart J, Brook L, Hopkins V, Teeling J, Püntener U, Culliford D, Sharples R, Sharif S et al.. Neurology, 2015-05-01
Topic: Amyloid, tau and blood-test diagnosis
Objectives To determine whether the tumor necrosis factor α 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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APA 7th
Butchart, J., Brook, L., Hopkins, V., Teeling, J., Püntener, U., Culliford, D., et al. (2015). Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial. Neurology. https://doi.org/10.1212/wnl.0000000000001617
Vancouver
Butchart J, Brook L, Hopkins V, Teeling J, Püntener U, Culliford D, et al. Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial. Neurology. 2015. doi:10.1212/wnl.0000000000001617. PMID: 25934853.
BibTeX
@article{butchart2015-25934853,
author = {Butchart, J. and Brook, L. and Hopkins, V. and Teeling, J. and Püntener, U. and Culliford, D. and Sharples, R. and Sharif, S. and others},
title = {{Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial}},
journal = {Neurology},
year = {2015},
doi = {10.1212/wnl.0000000000001617},
pmid = {25934853},
url = {https://doi.org/10.1212/wnl.0000000000001617}
}
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Key findings
- 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.
- 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.
Why it matters
In this small phase 2 trial of 41 patients with mild to moderate Alzheimer disease, etanercept was well tolerated but there were no statistically significant changes in cognition, behavior, or global function. The study was small and the authors note that a larger trial is needed.
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Study details
- Participants20
- Evidence strengthHigh
How this study scored 72/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | 4 / 4 | Neurology: journal h-index 525 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2015 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 20 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 5 / 7 | Cited 249 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 19.2 citations a year over 13 year(s) since 2015 |
| Impact for its field and year | 4 / 6 | Cited 14.7× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 13 other studies in this library |
| Still being cited | 3 / 4 | Cited 50 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Clive Holmes: h-index 79 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Cardiff University: institution h-index 1,251 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 25934853) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 72 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1212/wnl.0000000000001617
- PubMed: 25934853
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
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