title: No effect of one-year treatment with indomethacin on Alzheimer's disease progression: a randomized controlled trial.
abstract: BACKGROUND
  The objective of this study was to determine whether treatment with the nonselective nonsteroidal anti-inflammatory drug (NSAID) indomethacin slows cognitive decline in patients with Alzheimer's disease (AD).
  
  
  RESULTS
  This double-blind, randomized, placebo-controlled trial was conducted between May 2000 and September 2005 in two hospitals in the Netherlands. 51 patients with mild to moderate AD were enrolled into the study. Patients received 100 mg indomethacin or placebo daily for 12 months. Additionally, all patients received omeprazole. The primary outcome measure was the change from baseline after one year of treatment on the cognitive subscale of the AD Assessment Scale (ADAS-cog). Secondary outcome measures included the Mini-Mental State Examination, the Clinician's Interview Based Impression of Change with caregiver input, the noncognitive subscale of the ADAS, the Neuropsychiatric Inventory, and the Interview for Deterioration in Daily life in Dementia. Considerable recruitment problems of participants were encountered, leading to an underpowered study. In the placebo group, 19 out of 25 patients completed the study, and 19 out of 26 patients in the indomethacin group. The deterioration on the ADAS-cog was less in the indomethacin group (7.8+/-7.6), than in the placebo group (9.3+/-10.0). This difference (1.5 points; CI -4.5-7.5) was not statistically significant, and neither were any of the secondary outcome measures.
  
  
  CONCLUSIONS
  The results of this study are inconclusive with respect to the hypothesis that indomethacin slows the progression of AD.
authors.affiliation: Department of Neurology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. d.dejong@neuro.umcn.nl
authors.forename: Daniëlle
authors.initials: D
authors.lastname: de Jong
authors.forename: René
authors.initials: R
authors.lastname: Jansen
authors.forename: Willibrord
authors.initials: W
authors.lastname: Hoefnagels
authors.forename: Marja
authors.initials: M
authors.lastname: Jellesma-Eggenkamp
authors.forename: Marcel
authors.initials: M
authors.lastname: Verbeek
authors.forename: George
authors.initials: G
authors.lastname: Borm
authors.forename: Berry
authors.initials: B
authors.lastname: Kremer
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D007213:Indomethacin