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Volumn 8, Issue 3, 2009, Pages 225-238

Washout and delayed start designs for identifying disease modifying effects in slowly progressive diseases using disease progression analysis

Author keywords

Alzheimer's disease; Delayed start design; Disease progression modelling; Parkinson's disease; Statistical power; Washout design

Indexed keywords

DRUG; PLACEBO;

EID: 73349127010     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.355     Document Type: Article
Times cited : (39)

References (36)
  • 1
    • 0035038023 scopus 로고    scopus 로고
    • Drug treatment effects on disease progression
    • DOI: 10.1146/annurev.pharmtox.41.1.625
    • Chan PL, Holford NH. Drug treatment effects on disease progression. Annual Review of Pharmacology and Toxicology 2001; 41:625-659. DOI: 10.1146/annurev.pharmtox.41.1.625.
    • (2001) Annual Review of Pharmacology and Toxicology , vol.41 , pp. 625-659
    • Chan, P.L.1    Holford, N.H.2
  • 2
    • 34548484589 scopus 로고    scopus 로고
    • Parkinson's disease
    • DOI: 10.1136/bmj.39289.437454.AD
    • Clarke CE. Parkinson's disease. British Medical Journal 2007; 335(7617):441-445. DOI: 10.1136/bmj.39289.437454.AD.
    • (2007) British Medical Journal , vol.335 , Issue.7617 , pp. 441-445
    • Clarke, C.E.1
  • 3
    • 41049099938 scopus 로고    scopus 로고
    • Progress in neuroprotection in Parkinson's disease
    • DOI: 10.1111/j.1468-1331.2008.02055.x
    • Schapira AH. Progress in neuroprotection in Parkinson's disease. European Journal of Neurology 2008; 15(Suppl 1):5-13. DOI: 10.1111/j.1468-1331.2008.02055.x.
    • (2008) European Journal of Neurology , vol.15 , Issue.SUPPL. 1 , pp. 5-13
    • Schapira, A.H.1
  • 4
    • 3142547870 scopus 로고    scopus 로고
    • A 'cure' for Parkinson's disease: Can neuroprotection be proven with current trial designs?
    • DOI: 10.1002/mds.20057
    • Clarke CE. A 'cure' for Parkinson's disease: can neuroprotection be proven with current trial designs? Movement Disorders 2004; 19(5):491-498. DOI: 10.1002/mds.20057.
    • (2004) Movement Disorders , vol.19 , Issue.5 , pp. 491-498
    • Clarke, C.E.1
  • 5
    • 33749515432 scopus 로고    scopus 로고
    • Challenges to demonstrating disease-modifying effects in Alzheimer's disease clinical trials
    • Cummings JL. Challenges to demonstrating disease-modifying effects in Alzheimer's disease clinical trials. Alzheimer's and Dementia 2006; 2(4):263-271.
    • (2006) Alzheimer's and Dementia , vol.2 , Issue.4 , pp. 263-271
    • Cummings, J.L.1
  • 6
    • 33745786419 scopus 로고    scopus 로고
    • Disease progression and pharmacodynamics in Parkinson disease-evidence for functional protection with levodopa and other treatments
    • DOI: 10.1007/s10928-006-9012-6
    • Holford NH, Chan PL, Nutt JG, Kieburtz K, Shoulson I. Disease progression and pharmacodynamics in Parkinson disease-evidence for functional protection with levodopa and other treatments. Journal of Pharmacokinetics and Pharmacodynamics 2006; 33(3):281-311. DOI: 10.1007/s10928-006-9012-6.
    • (2006) Journal of Pharmacokinetics and Pharmacodynamics , vol.33 , Issue.3 , pp. 281-311
    • Holford, N.H.1    Chan, P.L.2    Nutt, J.G.3    Kieburtz, K.4    Shoulson, I.5
  • 7
    • 34447301510 scopus 로고    scopus 로고
    • Clinical trials for neuroprotection in Parkinson's disease: Overcoming angst and futility?
    • DOI: 10.1097/WCO.0b013e32826388d6
    • Hung AY, Schwarzschild MA. Clinical trials for neuroprotection in Parkinson's disease: overcoming angst and futility? Current Opinion in Neurology 2007; 20(4):477-483. DOI: 10.1097/WCO.0b013e32826388d6.
    • (2007) Current Opinion in Neurology , vol.20 , Issue.4 , pp. 477-483
    • Hung, A.Y.1    Schwarzschild, M.A.2
  • 8
    • 33744929621 scopus 로고    scopus 로고
    • Finding potent drugs for Alzheimer's disease is more important than proving the drugs are disease modifying
    • Knopman D. Finding potent drugs for Alzheimer's disease is more important than proving the drugs are disease modifying. Alzheimer's and Dementia 2006; 2(3):147-149.
    • (2006) Alzheimer's and Dementia , vol.2 , Issue.3 , pp. 147-149
    • Knopman, D.1
  • 9
    • 0347093537 scopus 로고    scopus 로고
    • The evaluation of disease modifying therapies in Alzheimer's disease: A regulatory viewpoint
    • DOI: 10.1002/sim.1718
    • Mani RB. The evaluation of disease modifying therapies in Alzheimer's disease: a regulatory viewpoint. Statistics in Medicine 2004; 23(2):305-314. DOI: 10.1002/sim.1718.
    • (2004) Statistics in Medicine , vol.23 , Issue.2 , pp. 305-314
    • Mani, R.B.1
  • 10
    • 33845346815 scopus 로고    scopus 로고
    • Disease-modifying trials in Alzheimer's disease: A European task force consensus
    • DOI: 10.1016/S1474-4422(06)70677-9
    • Vellas B, Andrieu S, Sampaio C, Wilcock G. Disease-modifying trials in Alzheimer's disease: a European task force consensus. Lancet Neurology 2007; 6(1):56-62. DOI: 10.1016/S1474-4422(06)70677-9.
    • (2007) Lancet Neurology , vol.6 , Issue.1 , pp. 56-62
    • Vellas, B.1    Andrieu, S.2    Sampaio, C.3    Wilcock, G.4
  • 12
    • 2342655732 scopus 로고    scopus 로고
    • A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease
    • Parkinson Study Group, DOI: 10.1001/archneur.61.4.561
    • Parkinson Study Group. A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease. Archives of Neurology 2004; 61(4):561-566. DOI: 10.1001/archneur.61.4.561.
    • (2004) Archives of Neurology , vol.61 , Issue.4 , pp. 561-566
  • 13
    • 26444597591 scopus 로고    scopus 로고
    • Does levodopa slow or hasten the rate of progression of Parkinson's disease?
    • DOI: 10.1007/s00415-005-4008-5
    • Fahn S. Does levodopa slow or hasten the rate of progression of Parkinson's disease? Journal of Neurology 2005; 252(Suppl 4):IV37-IV42. DOI: 10.1007/s00415-005-4008-5.
    • (2005) Journal of Neurology , vol.252 , Issue.SUPPL. 4
    • Fahn, S.1
  • 14
    • 0036764810 scopus 로고    scopus 로고
    • Quantitative description of loss of clinical benefit following withdrawal of levodopa-carbidopa and bromocriptine in early Parkinson's disease
    • DOI: 10.1002/mds.10226
    • Hauser RA, Holford NH. Quantitative description of loss of clinical benefit following withdrawal of levodopa-carbidopa and bromocriptine in early Parkinson's disease. Movement Disorders 2002; 17(5):961-968. DOI: 10.1002/mds.10226.
    • (2002) Movement Disorders , vol.17 , Issue.5 , pp. 961-968
    • Hauser, R.A.1    Holford, N.H.2
  • 15
    • 33947105151 scopus 로고    scopus 로고
    • Levodopa slows progression of Parkinson's disease: External validation by clinical trial simulation
    • DOI: 10.1007/s11095-006-9202-3
    • Chan PL, Nutt JG, Holford NH. Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation. Pharmaceutical Research 2007; 24(4):791-802. DOI: 10.1007/s11095-006-9202-3.
    • (2007) Pharmaceutical Research , vol.24 , Issue.4 , pp. 791-802
    • Chan, P.L.1    Nutt, J.G.2    Holford, N.H.3
  • 16
    • 33749510058 scopus 로고    scopus 로고
    • Commentary on 'Challenges to demonstrating disease-modifying effects in Alzheimer's disease clinical trials'
    • Aisen PS. Commentary on 'Challenges to demonstrating disease-modifying effects in Alzheimer's disease clinical trials'. Alzheimer's and Dementia 2006; 2(4):272-274.
    • (2006) Alzheimer's and Dementia , vol.2 , Issue.4 , pp. 272-274
    • Aisen, P.S.1
  • 17
    • 33744900086 scopus 로고    scopus 로고
    • Optimal design of clinical trials for drugs designed to slow the course of Alzheimer's disease
    • Mohs RC, Kawas C, Carrillo MC. Optimal design of clinical trials for drugs designed to slow the course of Alzheimer's disease. Alzheimer's and Dementia 2006; 2(3):131-139.
    • (2006) Alzheimer's and Dementia , vol.2 , Issue.3 , pp. 131-139
    • Mohs, R.C.1    Kawas, C.2    Carrillo, M.C.3
  • 18
    • 0036906924 scopus 로고    scopus 로고
    • Design and analysis of two-period studies of potentially disease-modifying treatments
    • McDermott MP, Hall WJ, Oakes D, Eberly S. Design and analysis of two-period studies of potentially disease-modifying treatments. Controlled Clinical Trials 2002; 23(6):635-649.
    • (2002) Controlled Clinical Trials , vol.23 , Issue.6 , pp. 635-649
    • McDermott, M.P.1    Hall, W.J.2    Oakes, D.3    Eberly, S.4
  • 19
    • 48649093789 scopus 로고    scopus 로고
    • Are delayed-start design trials to show neuroprotection in Parkinson's disease fundamentally flawed?
    • DOI: 10.1002/mds.21918
    • Clarke CE. Are delayed-start design trials to show neuroprotection in Parkinson's disease fundamentally flawed? Movement Disorders 2008; 23(6):784-789. DOI: 10.1002/mds.21918.
    • (2008) Movement Disorders , vol.23 , Issue.6 , pp. 784-789
    • Clarke, C.E.1
  • 20
    • 0027530638 scopus 로고
    • Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. The Parkinson Study Group
    • Parkinson Study Group
    • Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. The Parkinson Study Group. The New England Journal of Medicine 1993; 328(3):176-183.
    • (1993) The New England Journal of Medicine , vol.328 , Issue.3 , pp. 176-183
  • 22
    • 3242717603 scopus 로고    scopus 로고
    • Alpha-dihydroergocryptine in the treatment of de novo Parkinsonian patients: Results of a multicentre, randomized, double-blind, placebo-controlled study
    • Bergamasco B, Frattola L, Muratorio A, Piccoli F, Mailland F, Parnetti L. Alpha-dihydroergocryptine in the treatment of de novo Parkinsonian patients: results of a multicentre, randomized, double-blind, placebo-controlled study. Acta Neurologica Scandinavica 2000; 101(6):372-380.
    • (2000) Acta Neurologica Scandinavica , vol.101 , Issue.6 , pp. 372-380
    • Bergamasco, B.1    Frattola, L.2    Muratorio, A.3    Piccoli, F.4    Mailland, F.5    Parnetti, L.6
  • 23
    • 34147143423 scopus 로고    scopus 로고
    • Randomized trial of the triple monoamine reuptake inhibitor NS 2330 (tesofensine) in early Parkinson's disease
    • DOI: 10.1002/mds.21258
    • Hauser RA, Salin L, Juhel N, Konyago VL. Randomized trial of the triple monoamine reuptake inhibitor NS 2330 (tesofensine) in early Parkinson's disease. Movement Disorders 2007; 22(3):359-365. DOI: 10.1002/mds.21258.
    • (2007) Movement Disorders , vol.22 , Issue.3 , pp. 359-365
    • Hauser, R.A.1    Salin, L.2    Juhel, N.3    Konyago, V.L.4
  • 24
    • 33846115045 scopus 로고    scopus 로고
    • A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease
    • The NINDS NET-PD Investigators, DOI: 10.1212/01.wnl.0000250355.28474.8e
    • The NINDS NET-PD Investigators. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology 2007; 68(1):20-28. DOI: 10.1212/01.wnl.0000250355.28474.8e.
    • (2007) Neurology , vol.68 , Issue.1 , pp. 20-28
  • 25
    • 0036894795 scopus 로고    scopus 로고
    • A controlled trial of rasagiline in early Parkinson disease: The TEMPO Study
    • Parkinson Study Group
    • Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease: the TEMPO Study. Archives of Neurology 2002; 59(12):1937-1943.
    • (2002) Archives of Neurology , vol.59 , Issue.12 , pp. 1937-1943
  • 27
    • 20944437732 scopus 로고    scopus 로고
    • Trial of subtherapeutic pergolide in de novo Parkinson's disease
    • DOI: 10.1002/mds.20361
    • Grosset K, Grosset D, Lees A. Trial of subtherapeutic pergolide in de novo Parkinson's disease. Movement Disorders 2005; 20(3):363-366. DOI: 10.1002/mds.20361.
    • (2005) Movement Disorders , vol.20 , Issue.3 , pp. 363-366
    • Grosset, K.1    Grosset, D.2    Lees, A.3
  • 29
    • 0346754905 scopus 로고    scopus 로고
    • A controlled trial of rotigotine monotherapy in early Parkinson's disease
    • Parkinson Study Group, DOI: 10.1001/archneur.60.12.1721
    • Parkinson Study Group. A controlled trial of rotigotine monotherapy in early Parkinson's disease. Archives of Neurology 2003; 60(12):1721-1728. DOI: 10.1001/archneur.60.12.1721.
    • (2003) Archives of Neurology , vol.60 , Issue.12 , pp. 1721-1728
  • 30
    • 33846438955 scopus 로고    scopus 로고
    • Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease
    • DOI: 10.1212/01.wnl. 0000252355.79284.22
    • Watts RL, Jankovic J, Waters C, Rajput A, Boroojerdi B, Rao J. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 2007; 68(4):272-276. DOI: 10.1212/01.wnl. 0000252355.79284.22.
    • (2007) Neurology , vol.68 , Issue.4 , pp. 272-276
    • Watts, R.L.1    Jankovic, J.2    Waters, C.3    Rajput, A.4    Boroojerdi, B.5    Rao, J.6
  • 31
    • 73349087556 scopus 로고    scopus 로고
    • Bhattaram VA, Siddiqu O, Gobburu J. Understanding Parkinson's disease: model-based approach. Available at: www.fda.gov/ohrms/dockets/ac/06/slides/2006- 4248s2-4-FDABhattaram&Siddiqui.ppt (last visited at 2008-04-27).
    • Bhattaram VA, Siddiqu O, Gobburu J. Understanding Parkinson's disease: model-based approach. Available at: www.fda.gov/ohrms/dockets/ac/06/slides/2006- 4248s2-4-FDABhattaram&Siddiqui.ppt (last visited at 2008-04-27).
  • 35
    • 0038402581 scopus 로고    scopus 로고
    • A joint model for nonlinear longitudinal data with informative dropout
    • Hu C, Sale ME. A joint model for nonlinear longitudinal data with informative dropout. Journal of Pharmacokinetics and Pharmacodynamics 2003; 30(1):83-103.
    • (2003) Journal of Pharmacokinetics and Pharmacodynamics , vol.30 , Issue.1 , pp. 83-103
    • Hu, C.1    Sale, M.E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.