TY - JOUR
T1 - EU/US/CTAD Task Force
T2 - Lessons Learned from Recent and Current Alzheimer's Prevention Trials
AU - Aisen, P.
AU - Touchon, J.
AU - Amariglio, R.
AU - Andrieu, S.
AU - Bateman, R.
AU - Breitner, John C.S.
AU - Donohue, M.
AU - Dunn, B.
AU - Doody, R.
AU - Fox, N.
AU - Gauthier, S.
AU - Grundman, M.
AU - Hendrix, S.
AU - Ho, C.
AU - Isaac, M.
AU - Raman, R.
AU - Rosenberg, P.
AU - Schindler, R.
AU - Schneider, L.
AU - Sperling, R.
AU - Tariot, P.
AU - Welsh-Bohmer, K.
AU - Weiner, M.
AU - Vellas, B.
PY - 2017
Y1 - 2017
N2 - At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient- and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.
AB - At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient- and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.
KW - Alzheimer’s disease
KW - clinical trials
KW - cognitive composites
KW - cognitive outcome measures
KW - informant-reported outcome measures
KW - mild behavioral impairment
KW - molecular imaging
KW - patient-reported outcome measures
KW - secondary prevention trials
UR - http://www.scopus.com/inward/record.url?scp=85054930234&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85054930234&partnerID=8YFLogxK
U2 - 10.14283/jpad.2017.13
DO - 10.14283/jpad.2017.13
M3 - Article
C2 - 29186281
AN - SCOPUS:85054930234
SN - 2426-0266
VL - 4
SP - 116
EP - 124
JO - The journal of prevention of Alzheimer's disease
JF - The journal of prevention of Alzheimer's disease
IS - 2
ER -