A randomized controlled trial of prednisone in Alzheimer’s disease
Abstract
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.
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Follow-up clinical trials of low-dose prednisone, low-dose aspirin, NSAIDs, and selective COX-2 inhibitors failed to show any reduction in rate of cognitive decline in mild to moderate Alzheimer disease.
“However, follow-up clinical trials testing the effect of low-dose prednisone (Aisen et al., 2000), low dose aspirin (AD2000 Collaborative Group et al., 2008), NSAIDS (Aisen et al., 2003; de Jong et al., 2008), and selective COX-2 inhibitors (Aisen et al., 2003; Thal et al., 2005) failed to show any reduction in rate of cognitive decline in mild to moderate AD.”
From Alzheimer Disease: An Update on Pathobiology and Treatment Strategies (2019) · cites this paper as Aisen et al., 2000
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Self-citation
- Authors
- Aisen, P. S., Davis, K. L., Berg, J. D., Schafer, K., Campbell, K., Thomas, R. G., Weiner, M. F., Farlow, M. R., Sano, M., Grundman, M., Thal, L. J., & Study, F. T. A. D. C.
- Affiliations
- Georgetown University Medical Center (US)
- Venue
- Neurology
- Published
- 2000-02-08
- Volume
- 54
- Issue
- 3
- Pages
- 588-588
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- OpenAlex
- W2980623457
- Cited by
- 464
- References
- 29
- Citations by year
- 2026: 12 · 2025: 6 · 2024: 9 · 2023: 6 · 2022: 8 · 2021: 11 · 2020: 17 · 2019: 14 · 2018: 13 · 2017: 8 · 2016: 14 · 2015: 18 · 2014: 13 · 2013: 16 · 2012: 17
- FWCI
- 26.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neurology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Aging (U01‐AG10483, U01AG010483, U19AG010483)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- prednisone, Alzheimer's disease, cognitive decline, anti-inflammatory therapy, immunosuppressive therapy, corticosteroids, behavioral decline, dose tapering
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Prednisone
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