Literature DB >> 21983242

Clinical trial methodologies for disease-modifying therapeutic approaches.

Paul S Aisen1.   

Abstract

In recent years, advances in Alzheimer's disease (AD) biomarker research have provided powerful tools to improve trial design. In particular, biomarkers provide powerful methods for the selection of individuals with Alzheimer's disease prior to the onset of dementia. Data suggest that neuroimaging biomarkers will be useful as endpoints for trials in very early, even asymptomatic disease, though further work is necessary to establish validity for regulatory purposes.
Copyright © 2011 Elsevier Inc. All rights reserved.

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Year:  2011        PMID： 21983242      PMCID： PMC3232303          DOI： 10.1016/j.neurobiolaging.2011.09.008

Source DB:  PubMed          Journal:  Neurobiol Aging        ISSN： 0197-4580            Impact factor:   4.673


  8 in total

Review 1.  Clinical Core of the Alzheimer's Disease Neuroimaging Initiative: progress and plans.

Authors:  Paul S Aisen; Ronald C Petersen; Michael C Donohue; Anthony Gamst; Rema Raman; Ronald G Thomas; Sarah Walter; John Q Trojanowski; Leslie M Shaw; Laurel A Beckett; Clifford R Jack; William Jagust; Arthur W Toga; Andrew J Saykin; John C Morris; Robert C Green; Michael W Weiner
Journal:  Alzheimers Dement       Date:  2010-05       Impact factor: 21.566

2.  Human amyloid-beta synthesis and clearance rates as measured in cerebrospinal fluid in vivo.

Authors:  Randall J Bateman; Ling Y Munsell; John C Morris; Robert Swarm; Kevin E Yarasheski; David M Holtzman
Journal:  Nat Med       Date:  2006-06-25       Impact factor: 53.440

3.  Safety and changes in plasma and cerebrospinal fluid amyloid beta after a single administration of an amyloid beta monoclonal antibody in subjects with Alzheimer disease.

Authors:  Eric R Siemers; Stuart Friedrich; Robert A Dean; Celedon R Gonzales; Martin R Farlow; Steven M Paul; Ronald B Demattos
Journal:  Clin Neuropharmacol       Date:  2010 Mar-Apr       Impact factor: 1.592

4.  11C-PiB PET assessment of change in fibrillar amyloid-beta load in patients with Alzheimer's disease treated with bapineuzumab: a phase 2, double-blind, placebo-controlled, ascending-dose study.

Authors:  Juha O Rinne; David J Brooks; Martin N Rossor; Nick C Fox; Roger Bullock; William E Klunk; Chester A Mathis; Kaj Blennow; Jerome Barakos; Aren A Okello; Sofia Rodriguez Martinez de Liano; Enchi Liu; Martin Koller; Keith M Gregg; Dale Schenk; Ronald Black; Michael Grundman
Journal:  Lancet Neurol       Date:  2010-02-26       Impact factor: 44.182

5.  Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade.

Authors:  Clifford R Jack; David S Knopman; William J Jagust; Leslie M Shaw; Paul S Aisen; Michael W Weiner; Ronald C Petersen; John Q Trojanowski
Journal:  Lancet Neurol       Date:  2010-01       Impact factor: 44.182

6.  A gamma-secretase inhibitor decreases amyloid-beta production in the central nervous system.

Authors:  Randall J Bateman; Eric R Siemers; Kwasi G Mawuenyega; Guolin Wen; Karen R Browning; Wendy C Sigurdson; Kevin E Yarasheski; Stuart W Friedrich; Ronald B Demattos; Patrick C May; Steven M Paul; David M Holtzman
Journal:  Ann Neurol       Date:  2009-07       Impact factor: 10.422

7.  Alzheimer's Disease Neuroimaging Initiative (ADNI): clinical characterization.

Authors:  R C Petersen; P S Aisen; L A Beckett; M C Donohue; A C Gamst; D J Harvey; C R Jack; W J Jagust; L M Shaw; A W Toga; J Q Trojanowski; M W Weiner
Journal:  Neurology       Date:  2009-12-30       Impact factor: 9.910

8.  Alzheimer's disease therapeutic research: the path forward.

Authors:  Paul S Aisen
Journal:  Alzheimers Res Ther       Date:  2009-07-09       Impact factor: 6.982
  8 in total
  7 in total

1.  Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.

Authors:  Anna Caroli; Annapaola Prestia; Sara Wade; Kewei Chen; Napatkamon Ayutyanont; Susan M Landau; Cindee M Madison; Cathleen Haense; Karl Herholz; Eric M Reiman; William J Jagust; Giovanni B Frisoni
Journal:  Alzheimer Dis Assoc Disord       Date:  2015 Apr-Jun       Impact factor: 2.703

2.  Indicators of amyloid burden in a population-based study of cognitively normal elderly.

Authors:  Michelle M Mielke; Heather J Wiste; Stephen D Weigand; David S Knopman; Val J Lowe; Rosebud O Roberts; Yonas E Geda; Dana M Swenson-Dravis; Bradley F Boeve; Matthew L Senjem; Prashanthi Vemuri; Ronald C Petersen; Clifford R Jack
Journal:  Neurology       Date:  2012-09-12       Impact factor: 9.910

3.  Imaging-based enrichment criteria using deep learning algorithms for efficient clinical trials in mild cognitive impairment.

Authors:  Vamsi K Ithapu; Vikas Singh; Ozioma C Okonkwo; Richard J Chappell; N Maritza Dowling; Sterling C Johnson
Journal:  Alzheimers Dement       Date:  2015-06-18       Impact factor: 21.566

Review 4.  Apolipoprotein E, gender, and Alzheimer's disease: an overlooked, but potent and promising interaction.

Authors:  Leo Ungar; Andre Altmann; Michael D Greicius
Journal:  Brain Imaging Behav       Date:  2014-06       Impact factor: 3.978

5.  Early identification and heritability of mild cognitive impairment.

Authors:  William S Kremen; Amy J Jak; Matthew S Panizzon; Kelly M Spoon; Carol E Franz; Wesley K Thompson; Kristen C Jacobson; Terrie Vasilopoulos; Eero Vuoksimaa; Hong Xian; Rosemary Toomey; Michael J Lyons
Journal:  Int J Epidemiol       Date:  2013-12-26       Impact factor: 7.196

6.  APOE-ε2 and APOE-ε4 correlate with increased amyloid accumulation in cerebral vasculature.

Authors:  Peter T Nelson; Nina M Pious; Gregory A Jicha; Donna M Wilcock; David W Fardo; Steven Estus; G William Rebeck
Journal:  J Neuropathol Exp Neurol       Date:  2013-07       Impact factor: 3.148

7.  Clinical trial design of serious gaming in mild cognitive impairment.

Authors:  Cristina Muscio; Pietro Tiraboschi; Ugo P Guerra; Carlo A Defanti; Giovanni B Frisoni
Journal:  Front Aging Neurosci       Date:  2015-03-11       Impact factor: 5.750
  7 in total

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