A randomized controlled trial of prednisone in Alzheimer's disease

Background: Laboratory and epidemiologic studies suggest that anti-inflamma tory/immunosuppressive therapy may be useful in the treatment of AD. In pre liminary studies, a regimen of low to moderate dose prednisone was found to suppress peripheral inflammatory markers without adverse effects in subjec ts with AD. Methods: We conducted a randomized, placebo-controlled multicen ter trial to determine whether prednisone treatment slowed the rate of cogn itive decline in AD. The active treatment regimen consisted of an initial d ose 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 additio nal 16 weeks. The primary outcome measure was the 1-year change in the cogn itive 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 t he primary intent-to-treat analysis, or in a secondary analysis considering completers only. Subjects treated with prednisone showed behavioral declin e compared with those in the placebo group. Conclusion: A low-dose regimen of prednisone is not; useful in the treatment of AD.