Report of the task force on designing clinical trials in early (predementia) AD

被引：144

作者：

Aisen, P. S. ^{[1
]}

Andrieu, S. ^{[2
]}

Sampaio, C. ^{[4
]}

Carrillo, M. ^{[5
]}

Khachaturian, Z. S. ^{[6
]}

Dubois, B. ^{[7
]}

Feldman, H. H. ^{[8
,9
]}

Petersen, R. C. ^{[10
]}

Siemers, E. ^{[11
]}

Doody, R. S. ^{[12
]}

Hendrix, S. B. ^{[13
]}

Grundman, M. ^{[14
]}

Schneider, L. S. ^{[15
]}

Schindler, R. J. ^{[16
]}

Salmon, E. ^{[18
]}

Potter, W. Z. ^{[19
]}

Thomas, R. G.

Salmon, D.

Donohue, M.

Bednar, M. M. ^{[17
]}

Touchon, J. ^{[20
]}

Vellas, B. ^{[3
]}

机构：

[1] UCSD, Dept Neurosci, La Jolla, CA 92093 USA

[2] Toulouse Univ Hosp, INSERM, UMR U558, Toulouse, France

[3] Toulouse Univ Hosp, INSERM, Gerontopole U1027, Toulouse, France

[4] Lisbon Sch Med, Lisbon, Portugal

[5] Alzheimers Assoc, Chicago, IL USA

[6] PAD2020, Rockville, MD USA

[7] Univ Salpetriere Hosp, Paris, France

[8] Bristol Myers Squibb Co, Wallingford, CT 06492 USA

[9] Yale Univ, New Haven, CT USA

[10] Mayo Clin, Rochester, MN USA

[11] Eli Lilly & Co, Indianapolis, IN 46285 USA

[12] Baylor Coll Med, Houston, TX 77030 USA

[13] Pentara Corp, Salt Lake City, UT USA

[14] Global R&D Partners, San Diego, CA USA

[15] Univ So Calif, Los Angeles, CA USA

[16] Pfizer Inc, New York, NY USA

[17] Pfizer Inc, Groton, CT 06340 USA

[18] Univ Liege, Liege, Belgium

[19] Merck, N Wales, PA USA

[20] F CHU Gui de Chauliacrance, Toulouse, France

来源：

NEUROLOGY | 2011年 / 76卷 / 03期

基金：

加拿大健康研究院;

关键词：

MILD COGNITIVE IMPAIRMENT; NEUROIMAGING INITIATIVE ADNI; ALZHEIMERS-DISEASE; CSF BIOMARKERS; FOLLOW-UP; PREVALENCE; PREDICTION; A-BETA(42); DIAGNOSIS; DEMENTIA;

D O I：

10.1212/WNL.0b013e318207b1b9

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

Background: A large number of promising candidate disease-modifying treatments for Alzheimer disease (AD) continue to advance into phase II and phase III testing. However, most completed trials have failed to demonstrate efficacy, and there is growing concern that methodologic difficulties may contribute to these clinical trial failures. The optimal time to intervene with such treatments is probably in the years prior to the onset of dementia, before the neuropathology has progressed to the advanced stage corresponding to clinical dementia. Method: An international task force of individuals from academia, industry, nonprofit foundations, and regulatory agencies was convened to discuss optimal trial design in early (predementia) AD. Results: General consensus was reached on key principles involving the scope of the AD diagnosis, the selection of subjects for trials, outcome measures, and analytical methods. Conclusion: A consensus has been achieved in support of the testing of candidate treatments in the early (predementia) AD population. Neurology (R) 2011; 76:280-286

引用

页码：280 / 286

页数：7

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