A randomized controlled study on effects of ibuprofen on cognitive progression of Alzheimer's disease
Pasqualetti P, Bonomini C, Dal Forno G, Paulon L, Sinforiani E, Marra C, Zanetti O, Rossini PM.. Aging clinical and experimental research, 2009-04-01
Topic: Amyloid, tau and blood-test diagnosis
Background and aims Epidemiological studies have examined the association between the use of non-steroidal anti-inflammatory drugs (NSAIDs) and the risk of Alzheimer's disease (AD). Recently, a variety of experimental studies indicates that a subset of NSAIDs, such as ibuprofen or flurbiprofen, also have Abeta-lowering properties in both AD transgenic mice and cell cultures of peripheral, glial and neuronal origin. In this trial, we evaluated whether the non-selective NSAID ibuprofen slows disease progression in patients with mild to moderate AD. Methods This was a 12-month multicenter, randomized, double-blind, placebo-controlled, parallel group trial. Participants with mild-moderate AD (Mini-Mental State Examination score >15, Results Fifty-one patients (77%) in the ibuprofen vs 46 (70%) in the placebo group completed the protocol (p>0.20). In intention-to- treat analysis, ADAS-Cog score worsening was similar in the two groups (p=0.951, treatment difference= 0.1, CI -2.7; 2.9). No differences were found for any secondary outcomes. In a subsample of genotyped patients, ApoE epsilon4 carriers treated with ibuprofen (n=27) were the only group without significant cognitive decline. Conclusions Ibuprofen, if used for relatively short periods of time and although well tolerated thanks to gastroprotection, does not seem to be effective in tertiary prevention of mild-moderate AD. Our results suggest the need to examine whether differences in the response to NSAIDs exist, based on ApoE epsilon4 carrier status.
Key findings
- Recently, a variety of experimental studies indicates that a subset of NSAIDs, such as ibuprofen or flurbiprofen, also have Abeta-lowering properties in both AD transgenic mice and cell cultures of peripheral, glial and neuronal origin.
- Participants with mild-moderate AD (Mini-Mental State Examination score >15, Results Fifty-one patients (77%) in the ibuprofen vs 46 (70%) in the placebo group completed the protocol (p>0.20).
- In a subsample of genotyped patients, ApoE epsilon4 carriers treated with ibuprofen (n=27) were the only group without significant cognitive decline.
- Our results suggest the need to examine whether differences in the response to NSAIDs exist, based on ApoE epsilon4 carrier status.
Why it matters
In this 12-month randomized, double-blind, placebo-controlled trial, ibuprofen did not slow cognitive progression in mild to moderate Alzheimer's disease, with similar ADAS-Cog worsening in both groups and no differences in secondary outcomes. The authors concluded ibuprofen does not seem effective in tertiary prevention of mild-moderate Alzheimer's disease.
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Study details
- Participants27
- Evidence strengthHigh
How this study scored 67/100
Published in a peer-reviewed 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 | 7 / 10 | Tier 3 — peer-reviewed journal (Aging clinical and experimental research) |
| Journal's citation record | 1 / 4 | Aging Clinical and Experimental Research: journal h-index 125 (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 | 2009 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 27 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 172 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 9.1 citations a year over 19 year(s) since 2009 |
| Impact for its field and year | 4 / 6 | Cited 8.3× 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 | 2 / 4 | Cited 17 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Paolo Maria Rossini: h-index 121 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Medical College of Wisconsin: institution h-index 747 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 19448381) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 67 / 100 | — |
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Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 8 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
Pasqualetti, P., Bonomini, C., Dal Forno, G., Paulon, L., Sinforiani, E., Marra, C., et al. (2009). A randomized controlled study on effects of ibuprofen on cognitive progression of Alzheimer's disease. Aging clinical and experimental research. https://doi.org/10.1007/bf03325217
Vancouver
Pasqualetti P, Bonomini C, Dal Forno G, Paulon L, Sinforiani E, Marra C, et al. A randomized controlled study on effects of ibuprofen on cognitive progression of Alzheimer's disease. Aging clinical and experimental research. 2009. doi:10.1007/bf03325217. PMID: 19448381.
BibTeX
@article{pasqualetti2009-19448381,
author = {Pasqualetti, P. and Bonomini, C. and Dal Forno, G. and Paulon, L. and Sinforiani, E. and Marra, C. and Zanetti, O. and Rossini, P. M.},
title = {{A randomized controlled study on effects of ibuprofen on cognitive progression of Alzheimer's disease}},
journal = {Aging clinical and experimental research},
year = {2009},
doi = {10.1007/bf03325217},
pmid = {19448381},
url = {https://doi.org/10.1007/bf03325217}
}
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