Alzheimer disease: Disease modifying trials where are we? Where do we need to go? A reflective paper

Journal of Nutrition, Health and Aging

Volumn 10, Issue 2, 2006, Pages 113-115

  Sampaio, C ^a,b  

^a INSTITUTO DE MEDICINA MOLECULAR   (Portugal)

^b HOSPITAL DE SANTA MARIA   (Portugal)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; ATORVASTATIN; DONEPEZIL; ESTROGEN; GALANTAMINE; GESTAGEN; HYDROXYCHLOROQUINE; NAPROXEN; PIRACETAM; PREDNISONE; RALOXIFENE; RIVASTIGMINE; ROFECOXIB;

ALZHEIMER DISEASE; AMYOTROPHIC LATERAL SCLEROSIS; CLINICAL TRIAL; COGNITIVE DEFECT; CONFERENCE PAPER; DEMENTIA; DISEASE COURSE; HUMAN; PRIMARY PREVENTION; PRIORITY JOURNAL; STROKE;

EID: 33646008227     PISSN: 12797707     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (31)

1. Aizheimer Disease In Dementia. A clinical approach. Mendez MF and Cummings JL , Butterworth Heinemann, USA, 2003.
2. Mann UM, Mohr E, Gearing M, Chase TN. Heterogeneity in Aizheimer Disease progression rate segregated by distinct neuropsychological and cerebral metabolic profiles. J Neurol Neurosurg Psychiat 1992; 55:956-959.
3. CPMP Note for guidance on clinical investigation of medicinal products for the treatment of multiple sclerosis, www.emea.eu.int/pdfs/human/ewp/056198en.pdf accessed on March 25, 2005.
4. Hilbush BS, Morrison JH,†Young, WG, Sutcliffe, JG,Bloom FE. New Prospects and Strategies for Drug Target Discovery in Neurodegenerative Disorders. NeuroRX 2005; 2:627-637.
5. Mulnard RA, Cotman CW, Kawas C, van Dyck CH, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal LJ. Estrogen replacement therapy for treatment of mild to moderate Aizheimer disease: a randomized controlled trial. Alzheimer's Disease Cooperative Study. JAMA. 2000;283(8):1007-15.
6. Yaffe K, Krueger K, Cummings SR, Blackwell T, Henderson VW, Sarkar S, Ensrud K, Grady D. Effect of raloxifene on prevention of dementia and cognitive impairment in older women: the Multiple Outcomes of Raloxifene Evaluation (MORE) randomized trial. Am J Psychiatry. 2005 (4): 683-90.
7. Petersen RC, Thomas RG, Grundman M, et al. Vitamin E and donepezil for the treatment of mild cognitive impairment. N Engl J Med 2005;352:2379-2388.
8. Johnson SA, Simmon VF. Randomized, double-blind, placebo-controlled international clinical trial of the Ampakine CX516 in elderly participants with mild cognitive impairment: a progress report.J Mol Neurosci. 2002;19(1-2):197-20.
9. Visser PJ, Scheltens P, Verhey FR. Do MCI criteria in drug trials accurately identify subjects with predementia Alzheimer's disease?J Neurol Neurosurg Psychiatry. 2005 ;76(10):1348-54.
10. Feldman H, Scheltens P, Scarpini E, Hermann N, Mesenbrink P, Mancione L, Tekin S, Lane R, Ferns S. Behavioral symptoms in mild cognitive impairment. Neurology. 2004;62(7):1199-201.
11. Thai LJ, Ferris SH, Kirby L, Block GA, Lines CR, Yuen E, Assaid C, Nessly ML, Norman BA, Baranak CC, Reines SA; Rofecoxib Protocol 078 study group.A randomized, double-blind, study of rofecoxib in patients with mild cognitive impairment. Neuropsychopharmacology. 2005;30(6):1204-15
12. Thai L, Carta A, Clarke W, et al. A 1-year multicenter placebo-controlled study of acetyl-L-carnitine in patients with Alzheimer's disease. Neurology 1996; 47: 705-7.
13. Sparks DL, Sabbagh MN, Connor DJ, Lopez J, Launer IJ, Browne P, Wasser D, Johnson-Traver S, Lochhead J, Ziolwolski C. Atorvastatin for the treatment of mild to moderate Alzheimer disease: preliminary results. Arch Neurol. 2005; 62:753-757
14. Van Gool WA, Weinstein HC, Scheltens PK, Walstra GJ Effect of hydroxychloroquine on progression of dementia in early Alzheimer's disease: an 18-month randomised, double-blind, placebo-controlled study_. Lancet 2001; 358(9280) 455-460.
15. L. J. Thal, M. Grundman, J. Berg, K. Ernstrom, R. Margolin, E. Pfeiffer, M. F. Weiner, E. Zamrini, R. G. Thomas. Idebenone treatment fails to slow cognitive decline in Alzheimer's disease. Neurology 2003;61:1498-1502
16. Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ; Alzheimer's Disease Cooperative Study.Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003;289(21):2819-26
17. Aisen P, Davis K, Berg M, et al. A randomized controlled trial of prednisone in Alzheimer's disease. Neurology 2000; 54: 588-593.
18. Elm JJ, Goetz CG, Ravina B, Shannon K, Wooten GF, Tanner CM, Palesch YY, Huang P, Guimaraes P, Kamp C, Tilley BC, Kieburtz K; NET-PD Investigators. A responsive outcome for Parkinson's disease neuroprotection futility studies. Ann Neurol. 2005;57(2):197-203
19. Palesch YY, Tilley BC. An efficient multi-stage, single-arm Phase II futility design for ALS Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5 Suppl 1:55-6.
20. Palesch YY, Tilley BC, Sackett DL, Johnston KC, Woolson R. Applying a Phase II Futility Study Design to Therapeutic Stroke Trials. Stroke 2005 ; [Epub ahead of print]
21. Sano M, Ernesto C, Thomas RG, et al. A controlled trial of selegiline, -tocopherol, or both as treatment for Alzheimer's disease. N Engl J Med . 1997; 336: 1216-1222.
22. AD2000 Collaborative group.Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial_Lancet 2004; 363 (9427): 2105-2115.
23. Jack CR Jr, Slomkowski M, Gracon S, Hoover TM, Felmlee JP, Stewart K, Xu Y, Shiung M, O'Brien PC, Cha R, Knopman D, Petersen RC. MRI as a biomarker of disease progression in a therapeutic trial of milameline for AD. Neurology. 2003;60(2):253-60.
24. Fox NC, Black RS, Gilman S, Rossor MN, Griffith SG, Jenkins L, Koller M; AN1792(QS-21)-201 Study. Effects of Abeta immunization (AN1792) on MRI measures of cerebral volume in Alzheimer disease. Neurology;64(9):1563-72.
25. Leber P. Observations and suggestions on antidementia drug development. Alzheimer Dis Assoc Disord 1996; 10: Suppl 1:31-35.
26. Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease: the TEMPO Study. Arch Neurol. 2002;59(12):1937-43
27. Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thai LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 ;61(1):59-66.
28. Biomarkers Definition Working Group: Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 2001, 69:89-95
29. Lachin JM. A review of methods for futility stopping based on conditional power. Stat Med. 2005 Sep 30;24(18):2747-64.
30. Tilley BC, Pillemer SR, Heyse SP, Li S, Clegg DO, Alarcon GS. Global statistical tests for comparing multiple outcomes in rheumatoid arthritis trials. MIRA Trial Group. Arthritis Rheum. 1999; 42(9):1879-8
31. Tang L, Song J, Belin TR, Unutzer J. A comparison of imputation methods in a longitudinal randomized clinical trial. Stat Med. 2005;24 (14):2111-28.