Application of Clinical Trial Simulation to Compare Proof-of-Concept Study Designs for Drugs with a Slow Onset of Effect; An Example in Alzheimer's Disease

被引:0
|
作者
Peter Lockwood
Wayne Ewy
David Hermann
Nick Holford
机构
[1] Pfizer Global Research and Development,Department of Pharmacology and Clinical Pharmacology, School of Medicine
[2] deCODE genetics,undefined
[3] University of Auckland,undefined
来源
Pharmaceutical Research | 2006年 / 23卷
关键词
Alzheimer's disease; clinical trial simulation; pharmacokinetic pharmacodynamic model; trial design;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
相关论文
共 50 条
  • [41] Multi-parametric [18F]PI-2620 tau PET/MRI in Alzheimer's disease variants: A proof-of-concept study
    Melasch, J.
    Rullmann, M.
    Scherlach, C.
    Saur, D.
    Schroeter, M. L.
    Tiepolt, S.
    Stephens, A.
    Koglin, N.
    Hesse, S.
    Strauss, M.
    Brendel, M.
    Aghakhanyan, G.
    Schildan, A.
    Mishchenko, O.
    Patt, M.
    Classen, J.
    Hoffmann, K.
    Sabri, O.
    Barthel, H.
    EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING, 2021, 48 (SUPPL 1) : S173 - S173
  • [42] Classification of Patients with Alzheimer's Disease and Dementia with Lewy Bodies using Resting EEG Selected Features at Sensor and Source Levels: A Proof-of-Concept Study
    San-Martin, Rodrigo
    Fraga, Francisco J.
    Del Percio, Claudio
    Lizio, Roberta
    Noce, Giuseppe
    Nobili, Flavio
    Arnaldi, Dario
    D'Antonio, Fabrizia
    De Lena, Carlo
    Guntekin, Bahar
    Hanoglu, Lutfu
    Taylor, John Paul
    McKeith, Ian
    Stocchi, Fabrizio
    Ferri, Raffaele
    Onofrj, Marco
    Lopez, Susanna
    Bonanni, Laura
    Babiloni, Claudio
    CURRENT ALZHEIMER RESEARCH, 2021, 18 (12) : 956 - 969
  • [43] Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study
    McDade, Eric
    Cummings, Jeffrey L.
    Dhadda, Shobha
    Swanson, Chad J.
    Reyderman, Larisa
    Kanekiyo, Michio
    Koyama, Akihiko
    Irizarry, Michael
    Kramer, Lynn D.
    Bateman, Randall J.
    ALZHEIMERS RESEARCH & THERAPY, 2022, 14 (01)
  • [44] Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study
    Eric McDade
    Jeffrey L. Cummings
    Shobha Dhadda
    Chad J. Swanson
    Larisa Reyderman
    Michio Kanekiyo
    Akihiko Koyama
    Michael Irizarry
    Lynn D. Kramer
    Randall J. Bateman
    Alzheimer's Research & Therapy, 14
  • [45] A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody (vol 13, 80, 2021)
    Swanson, Chad J.
    Zhang, Yong
    Dhadda, Shobha
    Wang, Jinping
    Kaplow, June
    Lai, Robert Y. K.
    Lannfelt, Lars
    Bradley, Heather
    Rabe, Martin
    Koyama, Akihiko
    Reyderman, Larisa
    Berry, Donald A.
    Berry, Scott
    Gordon, Robert
    Kramer, Lynn D.
    Cummings, Jeffrey L.
    ALZHEIMERS RESEARCH & THERAPY, 2022, 14 (01)
  • [46] A Multi-Center Randomized Proof-of-Concept Clinical Trial Applying [18F]FDG-PET for Evaluation of Metabolic Therapy with Rosiglitazone XR in Mild to Moderate Alzheimer's Disease
    Tzimopoulou, Sofia
    Cunningham, Vincent J.
    Nichols, Thomas E.
    Searle, Graham
    Bird, Nick P.
    Mistry, Prafull
    Dixon, Ian J.
    Hallett, William A.
    Whitcher, Brandon
    Brown, Andrew P.
    Zvartau-Hind, Marina
    Lotay, Narinder
    Lai, Robert Y. K.
    Castiglia, Mary
    Jeter, Barbara
    Matthews, Julian C.
    Chen, Kewei
    Bandy, Dan
    Reiman, Eric M.
    Gold, Michael
    Rabiner, Eugenii A.
    Matthews, Paul M.
    JOURNAL OF ALZHEIMERS DISEASE, 2010, 22 (04) : 1241 - 1256
  • [47] Beneficial effect of repetitive transcranial magnetic stimulation combined with cognitive training for the treatment of Alzheimer’s disease: a proof of concept study
    Jonathan Bentwich
    Evgenia Dobronevsky
    Sergio Aichenbaum
    Ran Shorer
    Ruth Peretz
    Michael Khaigrekht
    Revital Gandelman Marton
    Jose M. Rabey
    Journal of Neural Transmission, 2011, 118 : 463 - 471
  • [48] Beneficial effect of repetitive transcranial magnetic stimulation combined with cognitive training for the treatment of Alzheimer's disease: a proof of concept study
    Bentwich, Jonathan
    Dobronevsky, Evgenia
    Aichenbaum, Sergio
    Shorer, Ran
    Peretz, Ruth
    Khaigrekht, Michael
    Marton, Revital Gandelman
    Rabey, Jose M.
    JOURNAL OF NEURAL TRANSMISSION, 2011, 118 (03) : 463 - 471
  • [49] Patient-centred rehabilitation for non-communicable disease in a low-resource setting: study protocol for a feasibility and proof-of-concept randomised clinical trial
    Heine, Martin
    Fell, Brittany Leigh
    Robinson, Ashleigh
    Abbas, Mumtaz
    Derman, Wayne
    Hanekom, Susan
    BMJ OPEN, 2019, 9 (04):
  • [50] Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder with peripartum onset: A multicenter, open-label, controlled proof-of-concept clinical trial (DELOS-1)
    Deligiannidis, Kristina M.
    Robakis, Thalia
    Homitsky, Sarah C.
    Ibroci, Erona
    King, Bridget
    Jacob, Sunu
    Coppola, Diana
    Raines, Shane
    Alataris, Konstantinos
    JOURNAL OF AFFECTIVE DISORDERS, 2022, 316 : 34 - 41