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A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study
Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, Weiner MF, Farlow MR et al.. Neurology, 2000-02-01
Topic: Drug trials: efficacy and safety
Background Laboratory and epidemiologic studies suggest that anti-inflammatory/immunosuppressive therapy may be useful in the treatment of AD. In preliminary studies, a regimen of low to moderate dose prednisone was found to suppress peripheral inflammatory markers without adverse effects in subjects with AD. Methods We conducted a randomized, placebo-controlled multicenter trial to determine whether prednisone treatment slowed the rate of cognitive decline in AD. The active treatment regimen consisted of an initial dose of 20 mg of prednisone daily for 4 weeks tapered to a maintenance dose of 10 mg daily for 1 year, followed by gradual withdrawal during an additional 16 weeks. The primary outcome measure was the 1-year change in the cognitive subscale of the AD Assessment Scale. Results A total of 138 subjects were randomized to the drug and placebo groups. There was no difference in cognitive decline between the prednisone and placebo treatment groups in the primary intent-to-treat analysis, or in a secondary analysis considering completers only. Subjects treated with prednisone showed behavioral decline compared with those in the placebo group. Conclusion A low-dose regimen of prednisone is not useful in the treatment of AD.
Key findings
- Background Laboratory and epidemiologic studies suggest that anti-inflammatory/immunosuppressive therapy may be useful in the treatment of AD.
- Results A total of 138 subjects were randomized to the drug and placebo groups.
- Subjects treated with prednisone showed behavioral decline compared with those in the placebo group.
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Study details
- Participants138
- Evidence strengthHigh
How this study scored 77/100
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. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record and institution's track record, so those were left out: it earned 47 of the 61 points we could judge it on, which is 77 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| 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 | 2000 — older than 20 years, still counted |
| Sample size | 2 / 4 | 138 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 | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 10680787) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 47 / 61 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 47 of the 61 points we could judge it on is 77 out of 100. |
| Total | 77 / 100 | — |
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APA 7th
Aisen, P. S., Davis, K. L., Berg, J. D., Schafer, K., Campbell, K., Thomas, R. G., et al. (2000). A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study. Neurology. https://doi.org/10.1212/wnl.54.3.588
Vancouver
Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, et al. A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study. Neurology. 2000. doi:10.1212/wnl.54.3.588. PMID: 10680787.
BibTeX
@article{aisen2000-10680787,
author = {Aisen, P. S. and Davis, K. L. and Berg, J. D. and Schafer, K. and Campbell, K. and Thomas, R. G. and Weiner, M. F. and Farlow, M. R. and others},
title = {{A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study}},
journal = {Neurology},
year = {2000},
doi = {10.1212/wnl.54.3.588},
pmid = {10680787},
url = {https://doi.org/10.1212/wnl.54.3.588}
}