Addressing the challenges to successful recruitment and retention in Alzheimer's disease clinical trials

被引:143
作者
Grill, Joshua D. [1 ]
Karlawish, Jason [2 ,3 ]
机构
[1] Univ Calif Los Angeles, Dept Neurol, Mary S Easton Ctr Alzheimers Dis Res, Los Angeles, CA 90095 USA
[2] Univ Penn, Dept Med, Penn Ctr Bioeth, Penn Memory Ctr, Philadelphia, PA 19104 USA
[3] Univ Penn, Dept Med Eth, Penn Ctr Bioeth, Penn Memory Ctr, Philadelphia, PA 19104 USA
关键词
MILD COGNITIVE IMPAIRMENT; PLACEBO-CONTROLLED-TRIAL; DOUBLE-BLIND; GLOBAL FUNCTION; MODERATE; DONEPEZIL; DEMENTIA; AD; PARTICIPATION; DECLINE;
D O I
10.1186/alzrt58
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Among the key challenges in Alzheimer's disease drug development is the timely completion of clinical trials. Unfortunately, clinical trials often suffer from slow or insufficient enrollment. Successful clinical trial recruitment describes a balance between expeditiously achieving full enrollment and ensuring an appropriate study sample. Investigators face a number of challenges to the successful negotiation of this balance. The failure to address these challenges means that drug development may take more time and money and that trial results may not adequately represent drug efficacy or may not be applicable beyond the study. We review the challenges to recruitment and retention in Alzheimer's disease clinical trials and present a framework to address them.
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页数:11
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共 71 条
[1]   High-dose B vitamin supplementation and cognitive decline in Alzheimer disease - A randomized controlled trial [J].
Aisen, Paul S. ;
Schneider, Lon S. ;
Sano, Mary ;
Diaz-Arrastia, Ramon ;
van Dyck, Christopher H. ;
Weiner, Myron F. ;
Bottiglieri, Teodoro ;
Jin, Shelia ;
Stokes, Karen T. ;
Thomas, Ronald G. ;
Thal, Leon J. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (15) :1774-1783
[2]   Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression - A randomized controlled trial [J].
Aisen, PS ;
Schafer, KA ;
Grundman, M ;
Pfeiffer, E ;
Sano, M ;
Davis, KL ;
Farlow, MR ;
Jin, S ;
Thomas, RG ;
Thal, LJ .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 289 (21) :2819-2826
[3]   Participation in clinical trials and long-term outcomes in Alzheimer's disease [J].
Albert, SM ;
Sane, M ;
Marder, K ;
Jacobs, DM ;
Brandt, J ;
Albert, M ;
Stern, Y .
NEUROLOGY, 1997, 49 (01) :38-43
[4]  
Alzheimer's Association, 2010, Alzheimers Dement, V6, P158, DOI 10.1016/j.jalz.2010.01.009
[5]   Donepezil preserves cognition and global function in patients with severe Alzheimer disease [J].
Black, S. E. ;
Doody, R. ;
Li, H. ;
McRae, T. ;
Jambor, K. M. ;
Xu, Y. ;
Sun, Y. ;
Perdomo, C. A. ;
Richardson, S. .
NEUROLOGY, 2007, 69 (05) :459-469
[6]   Defining the role of the caregiver in Alzheimer's disease treatment [J].
Brodaty, H ;
Green, A .
DRUGS & AGING, 2002, 19 (12) :891-898
[7]   Comparison of Recruitment Efforts Targeted at Primary Care Physicians Versus the Community at Large for Participation in Alzheimer Disease Clinical Trials [J].
Carr, Sarah A. ;
Davis, Roberta ;
Spencer, Diane ;
Smart, Marie ;
Hudson, Joanna ;
Freeman, Stephanie ;
Cooper, Greg E. ;
Schmitt, Fred A. ;
Markesbery, William R. ;
Danner, Deborah ;
Jicha, Gregory A. .
ALZHEIMER DISEASE & ASSOCIATED DISORDERS, 2010, 24 (02) :165-170
[8]   Caregivers' attitudes toward their family members' participation in Alzheimer disease research: Implications for recruitment and retention [J].
Connell, CM ;
Shaw, BA ;
Holmes, SB ;
Foster, NL .
ALZHEIMER DISEASE & ASSOCIATED DISORDERS, 2001, 15 (03) :137-145
[9]   Donepezil treatment of patients with MCI A 48-week randomized, placebo-controlled trial [J].
Doody, R. S. ;
Ferris, S. H. ;
Salloway, S. ;
Sun, Y. ;
Goldman, R. ;
Watkins, W. E. ;
Xu, Y. ;
Murthy, A. K. .
NEUROLOGY, 2009, 72 (18) :1555-1561
[10]   Effect of dimebon on cognition, activities of daily living, behaviour, and global function in patients with mild-to-moderate Alzheimer's disease: a randomised, double-blind, placebo-controlled study [J].
Doody, Rachelle S. ;
Gavrilova, Svetlana I. ;
Sano, Mary ;
Thomas, Ronald G. ;
Aisen, Paul S. ;
Bachurin, Sergey O. ;
Seely, Lynn ;
Hung, David .
LANCET, 2008, 372 (9634) :207-215