Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 5, Issue 5 , Pages 388-397 , September 2009

Current Alzheimer's disease clinical trials: Methods and placebo outcomes

  • Lon S. Schneider

      Affiliations

    • Department of Psychiatry and the Behavioral Sciences and Department of Neurology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA
    • Corresponding Author InformationCorresponding author. Tel.: 323-442-7600; Fax: 323-442-7601.
    • ,
  • Mary Sano

      Affiliations

    • Department of Psychiatry, Mt Sinai School of Medicine, New York, NY, USA

References 

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  2. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias. Available at: http://www.emea.europa.eu/pdfs/human/ewp/055395en.pdf. Accessed May 5, 2009.
  3. Schneider LS. Issues in design and conductance of clinical trials for cognitive-enhancing drugs. In: Animal and translational models of behavioural disorders. In: McArthur RA, Borsini F, eds. Neurological disorders. Volume 2. New York: Elsevier; 2008.
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  12. Anonymous. PhRMA Web Synopsis: protocol A2581078 01 June 2008 Final—an 80-week, randomized, multi-center, parallel-group, double-blind study of the efficacy and safety of atorvastatin 80 mg plus an acetylcholinesterase inhibitor versus an acetylcholinesterase inhibitor alone in the treatment of mild to moderate Alzheimer's disease. Available at: http://pdf.clinicalstudyresults.org/documents/company-study_4374_0.pdf. Accessed April 15, 2009.
  13. Sano M. Multi-center, randomized, double-blind, placebo-controlled trial of simvastatin to slow the progression of Alzheimer's disease: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T200.
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  16. Saumier D. Lessons learned in trial design: the ALZHEMEDTM (Tramiprosate) experience. Alzheimer's Association Research Roundtable, Washington, DC, Oct 2008.
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  26. Schneider LS, Dagerman KS, Shaikh Z, Insel P. No secular trend and high variability for ADAS-cog change among placebo groups from clinical trials: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T167.
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PII: S1552-5260(09)02128-1

doi: 10.1016/j.jalz.2009.07.038

Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 5, Issue 5 , Pages 388-397 , September 2009

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