Optimal composite scores for longitudinal clinical trials under the linear mixed effects model

Author:

Ard M. Colin1,Raghavan Nandini2,Edland Steven D.13

Affiliation:

1. Department of Neurosciences University of California, San Diego La Jolla CA USA

2. Janssen Research & Development, LLC Raritan NJ USA

3. Division of Biostatistics, Department of Family and Preventive Medicine University of California San Diego, La Jolla CA USA

Funder

National Institute on Aging

Janssen Research and Development

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference16 articles.

1. Improved Statistical Power of Alzheimer Clinical Trials by Item-Response Theory

2. Power calculations for clinical trials in Alzheimer's disease;Ard MC;Journal of Alzheimer's Disease,2011

3. US Dept of Health and Human Services; US Food and Drug Administration; Center for Drug Evaluation and Research.Guidance for industry: Alzheimer's disease: developing drugs for the treatment of early stage disease (draft guidance). Available at:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf. (Published February 2013. Accessed 19 June 2014).

4. Regulatory Innovation and Drug Development for Early-Stage Alzheimer's Disease

5. The ADAS‐Cog revisited: Novel composite scales based on ADAS‐Cog to improve efficiency in MCI and early AD trials

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