메뉴 건너뛰기




Volumn 5, Issue 5, 2009, Pages 388-397

Current Alzheimer's disease clinical trials: Methods and placebo outcomes

Author keywords

Activities of daily living; Alzheimer's disease; Alzheimer's Disease Assessment Scale (ADAS); Amyloid beta protein; Cholinesterase inhibitors; Clinical Dementia Rating scale; Clinical global impression of change; Clinical trials; Clinical trials methods; Memantine

Indexed keywords

AAC 001; ACC 001 VACCINE; ADVANCED GLYCATION END PRODUCT RECEPTOR ANTAGONIST; AGENTS INTERACTING WITH TRANSMITTER, HORMONE OR DRUG RECEPTORS; ALZHEIMER DISEASE VACCINE; ATORVASTATIN; AZD 103; BAPINEUZUMAB; CHOLINESTERASE INHIBITOR; DOCOSAHEXAENOIC ACID; ELND 005; GAMMA SECRETASE INHIBITOR; HOMOTAURINE; IMMUNOGLOBULIN; INOSITOL DERIVATIVE; MEMANTINE; N2 [2 (3,5 DIFLUOROPHENYL) 2 HYDROXYACETYL] N1 (6,7 DIHYDRO 5 METHYL 6 OXO 5H DIBENZ[B,D]AZEPIN 7 YL)ALANINAMIDE; PF 04360365; PF 04494700; PF 4360365; PLACEBO; QS 21; SCYLLO INOSITOL; SEMAGACESTAT; SIMVASTATIN; TARENFLURBIL; TTP 448; UNCLASSIFIED DRUG; VITAMIN B GROUP; XALIPRODEN;

EID: 69949123520     PISSN: 15525260     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jalz.2009.07.038     Document Type: Article
Times cited : (127)

References (34)
  • 1
    • 6944257397 scopus 로고    scopus 로고
    • What is the evidence that a dementia treatment works? criteria used by drug regulatory authorities
    • Qizilbash N., Schneider L.S., Chui H., et al. (Eds), Blackwells, Oxford, UK
    • Leber P. What is the evidence that a dementia treatment works? criteria used by drug regulatory authorities. In: Qizilbash N., Schneider L.S., Chui H., et al. (Eds). Evidence-based dementia practice (2003), Blackwells, Oxford, UK 376-387
    • (2003) Evidence-based dementia practice , pp. 376-387
    • Leber, P.1
  • 2
  • 3
    • 77954116746 scopus 로고    scopus 로고
    • Issues in design and conductance of clinical trials for cognitive-enhancing drugs
    • Animal and translational models of behavioural disorders, McArthur RA, Borsini F, eds, New York: Elsevier;
    • Schneider LS. Issues in design and conductance of clinical trials for cognitive-enhancing drugs. In: Animal and translational models of behavioural disorders. In: McArthur RA, Borsini F, eds. Neurological disorders. Volume 2. New York: Elsevier; 2008.
    • (2008) Neurological disorders , vol.2
    • Schneider, L.S.1
  • 4
    • 38049022527 scopus 로고    scopus 로고
    • Prevention therapeutics of dementia
    • Schneider L.S. Prevention therapeutics of dementia. Alzheimers Dementia 4 (2008) S122-S130
    • (2008) Alzheimers Dementia , vol.4
    • Schneider, L.S.1
  • 5
    • 33744900086 scopus 로고    scopus 로고
    • Optimal design of clinical trials for drugs designed to slow the course of Alzheimer's disease
    • Mohs R.C., Kawas C., and Carillo M.C. Optimal design of clinical trials for drugs designed to slow the course of Alzheimer's disease. Alzheimers Dementia 2 (2006) 131-139
    • (2006) Alzheimers Dementia , vol.2 , pp. 131-139
    • Mohs, R.C.1    Kawas, C.2    Carillo, M.C.3
  • 6
    • 33845346815 scopus 로고    scopus 로고
    • Disease-modifying trials in Alzheimer's disease: a European task force consensus
    • Vellas B., Andrieu S., Sampaio C., and Wilcock G. Disease-modifying trials in Alzheimer's disease: a European task force consensus. Lancet Neurol 6 (2007) 56-62
    • (2007) Lancet Neurol , vol.6 , pp. 56-62
    • Vellas, B.1    Andrieu, S.2    Sampaio, C.3    Wilcock, G.4
  • 7
    • 0021520020 scopus 로고
    • A new rating scale for Alzheimer's disease
    • Rosen W.G., Mohs R.C., and Davis K.L. A new rating scale for Alzheimer's disease. Am J Psychiatry 141 (1984) 1356-1364
    • (1984) Am J Psychiatry , vol.141 , pp. 1356-1364
    • Rosen, W.G.1    Mohs, R.C.2    Davis, K.L.3
  • 8
    • 0027425211 scopus 로고
    • The Clinical Dementia Rating (CDR): current version and scoring rules
    • Morris J.C. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology 43 (1993) 2412-2414
    • (1993) Neurology , vol.43 , pp. 2412-2414
    • Morris, J.C.1
  • 9
    • 0030862602 scopus 로고    scopus 로고
    • Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change
    • Schneider L.S., Olin J.T., Doody R.S., et al. Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Alzheimer Dis Assoc Disord 11 Suppl 2 (1997) S22-S32
    • (1997) Alzheimer Dis Assoc Disord , vol.11 , Issue.SUPPL. 2
    • Schneider, L.S.1    Olin, J.T.2    Doody, R.S.3
  • 10
    • 0030771116 scopus 로고    scopus 로고
    • An inventory to assess activities of daily living for clinical trials in Alzheimer's disease
    • Galasko D., Bennett D., Sano M., et al. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. Alzheimer Dis Assoc Disord 11 Suppl. (1997) 33S-39S
    • (1997) Alzheimer Dis Assoc Disord , vol.11 , Issue.SUPPL
    • Galasko, D.1    Bennett, D.2    Sano, M.3
  • 11
    • 0033193134 scopus 로고    scopus 로고
    • Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia
    • Gelinas I., Gauthier L., McIntyre M., and Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther 53 (1999) 471-481
    • (1999) Am J Occup Ther , vol.53 , pp. 471-481
    • Gelinas, I.1    Gauthier, L.2    McIntyre, M.3    Gauthier, S.4
  • 12
    • 69949114018 scopus 로고    scopus 로고
    • Anonymous. PhRMA Web Synopsis: protocol A2581078 01 June 2008 Final-an 80-week, randomized, multi-center, parallel-group, double-blind study of the efficacy and safety of atorvastatin 80 mg plus an acetylcholinesterase inhibitor versus an acetylcholinesterase inhibitor alone in the treatment of mild to moderate Alzheimer's disease. Available at: http://pdf.clinicalstudyresults.org/documents/company-study_4374_0.pdf. Accessed April 15, 2009.
    • Anonymous. PhRMA Web Synopsis: protocol A2581078 01 June 2008 Final-an 80-week, randomized, multi-center, parallel-group, double-blind study of the efficacy and safety of atorvastatin 80 mg plus an acetylcholinesterase inhibitor versus an acetylcholinesterase inhibitor alone in the treatment of mild to moderate Alzheimer's disease. Available at: http://pdf.clinicalstudyresults.org/documents/company-study_4374_0.pdf. Accessed April 15, 2009.
  • 13
    • 69949138128 scopus 로고    scopus 로고
    • Sano M. Multi-center, randomized, double-blind, placebo-controlled trial of simvastatin to slow the progression of Alzheimer's disease: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T200.
    • Sano M. Multi-center, randomized, double-blind, placebo-controlled trial of simvastatin to slow the progression of Alzheimer's disease: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T200.
  • 14
    • 54049106963 scopus 로고    scopus 로고
    • High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial
    • Aisen P.S., Schneider L.S., Sano M., et al. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. JAMA 300 (2008) 1774-1783
    • (2008) JAMA , vol.300 , pp. 1774-1783
    • Aisen, P.S.1    Schneider, L.S.2    Sano, M.3
  • 16
    • 69949124379 scopus 로고    scopus 로고
    • Lessons learned in trial design: The ALZHEMEDTM (Tramiprosate) experience
    • Washington, DC, Oct
    • Saumier D. Lessons learned in trial design: the ALZHEMEDTM (Tramiprosate) experience. Alzheimer's Association Research Roundtable, Washington, DC, Oct 2008.
    • (2008) Alzheimer's Association Research Roundtable
    • Saumier, D.1
  • 17
    • 69949158147 scopus 로고    scopus 로고
    • Green RC, Schneider LS, Hendrix SB, et al. Safety and efficacy of tarenflurbil in subjects with mild Alzheimer's disease: results from an 18-month multi-center phase III trial-Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 1): P86.
    • Green RC, Schneider LS, Hendrix SB, et al. Safety and efficacy of tarenflurbil in subjects with mild Alzheimer's disease: results from an 18-month multi-center phase III trial-Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 1): P86.
  • 18
    • 69949164968 scopus 로고    scopus 로고
    • Gilman S. Phase II trial of bapieumuzab for Alzheimer's disease: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T166.
    • Gilman S. Phase II trial of bapieumuzab for Alzheimer's disease: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T166.
  • 19
    • 69949123803 scopus 로고    scopus 로고
    • Wilcock GK, Black SE, Balch AH, et al. Safety and efficacy of tarenflurbil in subjects with mild Alzheimer's disease: results from an 18-month international multi-center phase 3 trial-Alzheimer's Association International Conference on Alzheimer's Disease. Vienna, Austria, July 13-16, 2009. Alzheimers Dementia 2009;5(Suppl 1):P86.
    • Wilcock GK, Black SE, Balch AH, et al. Safety and efficacy of tarenflurbil in subjects with mild Alzheimer's disease: results from an 18-month international multi-center phase 3 trial-Alzheimer's Association International Conference on Alzheimer's Disease. Vienna, Austria, July 13-16, 2009. Alzheimers Dementia 2009;5(Suppl 1):P86.
  • 20
    • 69949167618 scopus 로고    scopus 로고
    • Omega 3 fatty acids and Alzheimer's disease: trial design and baseline study population characteristics in a clinical trial of docosahexanoic acid for Alzheimer's disease
    • T773
    • Quinn J.F., Raman R., Thomas R., et al. Omega 3 fatty acids and Alzheimer's disease: trial design and baseline study population characteristics in a clinical trial of docosahexanoic acid for Alzheimer's disease. Alzheimers Dementia 4 Suppl 1 (2008) T773
    • (2008) Alzheimers Dementia , vol.4 , Issue.SUPPL. 1
    • Quinn, J.F.1    Raman, R.2    Thomas, R.3
  • 21
    • 0021271971 scopus 로고
    • Clinical diagnosis of Alzheimers disease: report of the NINCDS-AD Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimers Disease
    • McKhann G., Drachman D., Folstein M., et al. Clinical diagnosis of Alzheimers disease: report of the NINCDS-AD Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimers Disease. Neurology 34 (1984) 939-944
    • (1984) Neurology , vol.34 , pp. 939-944
    • McKhann, G.1    Drachman, D.2    Folstein, M.3
  • 22
    • 0016823810 scopus 로고
    • "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician
    • Folstein M.F., Folstein S.E., and McHugh P.R. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12 (1975) 189-198
    • (1975) J Psychiatr Res , vol.12 , pp. 189-198
    • Folstein, M.F.1    Folstein, S.E.2    McHugh, P.R.3
  • 23
    • 0030823158 scopus 로고    scopus 로고
    • L. Farrer LA, Cupples LA, Haines JL, et al. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease: a meta-analysis. JAMA 1997;278:1349-56.
    • L. Farrer LA, Cupples LA, Haines JL, et al. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease: a meta-analysis. JAMA 1997;278:1349-56.
  • 25
    • 0030814418 scopus 로고    scopus 로고
    • Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale (ADAS) that broaden its scope
    • Mohs R.C., Knopman D., Petersen R.C., et al. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale (ADAS) that broaden its scope. Alzheimer Dis Assoc Disord 11 (1997) S13-S21
    • (1997) Alzheimer Dis Assoc Disord , vol.11
    • Mohs, R.C.1    Knopman, D.2    Petersen, R.C.3
  • 26
    • 69949160144 scopus 로고    scopus 로고
    • Schneider LS, Dagerman KS, Shaikh Z, Insel P. No secular trend and high variability for ADAS-cog change among placebo groups from clinical trials: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T167.
    • Schneider LS, Dagerman KS, Shaikh Z, Insel P. No secular trend and high variability for ADAS-cog change among placebo groups from clinical trials: Alzheimer's Association International Conference on Alzheimer's Disease, Chicago, IL, July 26-31, 2008. Alzheimers Dementia 2008;4(Suppl 2):T167.
  • 27
    • 69949134497 scopus 로고    scopus 로고
    • Anonymous. FDA rejects wider application of Forest Labs Alzheimer's drug. The Wall Street Journal, July 25, 2005. Available at: http://online.wsj.com/article/SB112231577567995101.html?mod=googlewsj.
    • Anonymous. FDA rejects wider application of Forest Labs Alzheimer's drug. The Wall Street Journal, July 25, 2005. Available at: http://online.wsj.com/article/SB112231577567995101.html?mod=googlewsj.
  • 28
    • 20344381835 scopus 로고    scopus 로고
    • Vitamin E and donepezil for the treatment of mild cognitive impairment
    • Petersen R.C., Thomas R.G., Grundman M., et al. Vitamin E and donepezil for the treatment of mild cognitive impairment. N Engl J Med 352 (2005) 2379-2388
    • (2005) N Engl J Med , vol.352 , pp. 2379-2388
    • Petersen, R.C.1    Thomas, R.G.2    Grundman, M.3
  • 29
    • 34248372938 scopus 로고    scopus 로고
    • Effect of rivastigmine on delay to diagnosis of Alzheimer's disease from mild cognitive impairment: the InDDEx study
    • Feldman H.H., Ferris S., Winblad B., et al. Effect of rivastigmine on delay to diagnosis of Alzheimer's disease from mild cognitive impairment: the InDDEx study. Lancet Neurol 6 (2007) 501-512
    • (2007) Lancet Neurol , vol.6 , pp. 501-512
    • Feldman, H.H.1    Ferris, S.2    Winblad, B.3
  • 30
    • 45149132039 scopus 로고    scopus 로고
    • Safety and efficacy of galantamine in subjects with mild cognitive impairment
    • Winblad B., Gauthier S., Scinto L., et al. Safety and efficacy of galantamine in subjects with mild cognitive impairment. Neurology 70 (2008) 2024-2035
    • (2008) Neurology , vol.70 , pp. 2024-2035
    • Winblad, B.1    Gauthier, S.2    Scinto, L.3
  • 31
    • 34547231311 scopus 로고    scopus 로고
    • Six and 18-month changes in mild to moderate Alzheimer's patients treated with acetylcholinesterase inhibitors: what can we learn for clinical outcomes of therapeutic trials?
    • Cortes F., Portet F., Touchon J., and Vellas B. Six and 18-month changes in mild to moderate Alzheimer's patients treated with acetylcholinesterase inhibitors: what can we learn for clinical outcomes of therapeutic trials?. J Nutr Health Aging 11 (2007) 330-337
    • (2007) J Nutr Health Aging , vol.11 , pp. 330-337
    • Cortes, F.1    Portet, F.2    Touchon, J.3    Vellas, B.4
  • 32
    • 41949119170 scopus 로고    scopus 로고
    • Endpoints for trials in Alzheimer's disease: a European task force consensus
    • Vellas B., Andrieu S., Sampaio C., et al. Endpoints for trials in Alzheimer's disease: a European task force consensus. Lancet Neurol 7 (2008) 436-450
    • (2008) Lancet Neurol , vol.7 , pp. 436-450
    • Vellas, B.1    Andrieu, S.2    Sampaio, C.3
  • 33
    • 34547194399 scopus 로고    scopus 로고
    • Long-term changes in ADAS-cog: what is clinically relevant for disease modifying trials in Alzheimer?
    • Vellas B., Andrieu S., Cantet C., Dartigues J., and Gauthier S. Long-term changes in ADAS-cog: what is clinically relevant for disease modifying trials in Alzheimer?. J Nutr Health Aging 11 (2007) 338-341
    • (2007) J Nutr Health Aging , vol.11 , pp. 338-341
    • Vellas, B.1    Andrieu, S.2    Cantet, C.3    Dartigues, J.4    Gauthier, S.5
  • 34
    • 34547200153 scopus 로고    scopus 로고
    • Clinical relevance on Alzheimer's disease endpoints
    • Sampaio C. Clinical relevance on Alzheimer's disease endpoints. J Nutr Health Aging 11 (2007) 316-317
    • (2007) J Nutr Health Aging , vol.11 , pp. 316-317
    • Sampaio, C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.