A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: The preadvise trial

Journal of Nutrition, Health and Aging

Volumn 17, Issue 1, 2013, Pages 72-75

  Kryscio, R J ^a   Abner, E L ^a   Schmitt, F A ^a   Goodman, P J ^b   Mendiondo, M ^a   Caban Holt, A ^a   Dennis, B C ^a   Mathews, M ^a   Klein, E A ^c   Crowley, J J ^b  

^a UNIVERSITY OF KENTUCKY   (United States)

^b USA   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Alzheimer's disease; case ascertainment; cognitive assessments; prevention; telephone screening

Indexed keywords

ALPHA TOCOPHEROL; PLACEBO; SELENIUM;

ADULT; AFRICAN AMERICAN; AGED; ALZHEIMER DISEASE; ARTICLE; COGNITION; COGNITIVE DEFECT; CONTROLLED STUDY; DRUG EXPOSURE; FAMILY HISTORY; HUMAN; MAJOR CLINICAL STUDY; MALE; MEMORY; MEMORY DISORDER; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TELECONSULTATION; TREATMENT OUTCOME;

EID: 85027924487     PISSN: 12797707     EISSN: 17604788     Source Type: Journal    
DOI: 10.1007/s12603-013-0004-0     Document Type: Article

References (29)

1. Vellas, B. Aisen, P.S., Sampaio, C., Carrillo, M, et. al. (2011). Prevention trials in Alzheimer's disease: an EU-US task force report. Prog. Neurobiol., 95(4): 594-600.
2. Breitner, J.C. Baker, L.D., Montine T.J., Meinert, C.L., Lyketsos C.G. et al. (2011). Extended results of the Alzheimer's disease anti-inflammatory prevention trial. Alzheimers Dement. 7(4): 402-411
3. Espeland MA, Rapp SR, Shumaker SA, Brunner R, et al. (2004) Conjugated equine estrogens and global cognitive function in postmenopausal women: Women's Health Initiative Memory Study. J.A.M.A. 291(24): 2959-2968.
4. Shumaker SA, Legault C, Kuller L, Rapp SR, et al. (2004) Conjugated equine estrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women's Health Initiative Memory Study. J.A.M.A. 291(24): 2947-2958.
5. Snitz, B.E., O'Meara, E.S., Carlson, M.C., Arnold, A.M. et. al. (2009) Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial. J.A.M.A., 302(24): 2663-2670.
6. Dekosky ST, Williamson JD, Fitzpatrick AL, Ives DG, et al. (2008) Ginkgo biloba for prevention of dementia: a randomized controlled trial. J.A.M.A. 300(19): 2253-2262.
7. Goss-Sampson, M.A., MacEvilly, C.J., Muller, D.P.R. (1988) Longitudinal studies of the neurobiology of vitamin E and other antioxidant systems, and neurological function in the vitamin E deficient rat. J. Neurol. Sci. 87, 25-35.
8. Pillai, S.R., Traber, M.G., Steiss, J.E., Kayden, H.J., Cox, N.R. (1993) Alpha-Tocopherol concentration of the nervous system and selected tissues of adult dogs fed three levels of vitamin E. Lipids 28, 1101-1105.
9. Sano, M., Ernesto, C., Thomas, R.G., Klauber, M.R., Schafer, K., Grundman, M., Woodbury, P., Growdon, J., Cotman, C.W., Pfeiffer, E., Schneider, L.S., and Thal, L.J. (1997) A controlled trial of selegiline, alpha-tocopherol, or both as a treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N. Engl. J. Med. 336, 1216-1222.
10. Markesbery, W.R., Lovell, M.A. (1998) Four-hydroxynonenal, a product of lipid peroxidation, is increased in the brain in Alzheimer's disease. Neurobiol. Aging 19, 33-36.
11. Markesbery, W.R., Carney, J.M. (1999) Oxidative alterations in Alzheimer's disease. Brain Pathol. 9, 133-146.
12. Lippman, S.M., Klein, E.A., Goodman, P.J., et. al. (2009) Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer prevention Trial (SELECT). J.A.M.A., 301(1): 39-51.
13. Klein, E.A., Thompson Jr. I.M., Tangen, C. M., Crowley, J.J. et al. (2011). Vitamin E and the risk of prostate cancer: the selenium and vitamin E cancer prevention trial (SELECT). J.A.M.A., 306(14): 1549-1556.
14. Klein EA, Thompson IM, Lippman SM, et al. (2000) SELECT: the Selenium and Vitamin E Cancer prevention Trial: rationale and design. Prostate Cancer Prostatic Dis. 3(3): 145-151.
15. Caban-Holt, A., Schmitt, F.A., Runyons, C.R., Kryscio, R.J., Mendiondo, M.S., Sundquist, M.S., Markesbery, W.R., Coltman, C.A., Crowley, J.J., Goodman, P., & Hartline, J.A. (2006). Studying the effects of vitamin E and Selenium for Alzheimer's disease prevention: the PREADVISE model. In: Vellas B, Fitten L, Winblad B, Feldman H, Grundman M, Giacobini E, Kurz A (eds). Research and Practice in Alzheimer's Disease: Volume 11 (pp. 124-130). Paris: Serdi Publisher.
16. Buschke, H., Kulansky, G., Katz, M., Stewart, W.F., Sliwinski, M.J., Eckholdt, H.M., & Lipton, R.B. (1999). Screening for dementia with the Memory Impairment Screen. Neurology, 52, 231-238.
17. Morris, J.C., Heyman, R.C., Mohs, J.P., Hughes, B.G. et. al. (1989) The Consortium to establish a registry for Alzheimer's disease (CERAD). Part 1. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology 39: 1159-1165.
18. Welsh KA, Butters N, Mohs RC, Beekly D, Edland S, Fillenbaum G, Heyman A. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part V. A normative study of the neuropsychological battery. Neurology. 1994 Apr;44(4):609-614.
19. Lipton, R.B., Katz, M.J., Kuslansky, G., Sliwinski, M.J., Stewart, W.F., Verghese, J., Crystal, H.A., Buschke, H. (2003). Screening for dementia by telephone using the memory impairment screen. J. Am. Geriatr. Soc., 51(10): 1382-1390.
20. Brandt, J., Spencer, M., Folstein, M. (1988). The telephone interview for cognitive status. Neuropsychiatry, Neuropsychology & Behavioral Neurology 1: 111-117.
21. Plassman BL, Welsh KA, Helms M, Brandt J, Page WF, Breitner JC. Intelligence and education as predictors of cognitive state in late life: a 50-year follow-up. Neurology. 1995 Aug;45(8):1446-1450.
22. Welsh, K.A., Breitner, J.C.S., Magruder-Habbib, K.M. (1993) Detection of dementia in the elderly using telephone screening of cognitive status. Neuropsychiatry, Neuropsychology & Behavioral Neurology, 1: 103-111.
23. Galvin JE, Fagan AM, Holtzman DM, Mintun MA, Morris JC. Relationship of dementia screening tests with biomarkers of Alzheimer's disease. Brain. 2010 Nov;133(11):3290-3300.
24. Yesavage, J. A., Brink, T. L., Rose, T. L., Lum, O., Huang, V. S., et al. (1983). Development and validation of a geriatric depression screening scale: A preliminary report. Journal of Psychiatric Research, 17, 37-39.
25. Kryscio, R.J., Mendiondo, M.S., Schmitt, F.A., Markesbery, W.R. (2004). Designing a large prevention trial: statistical issues. Stat. Med., 23(2): 285-296.
26. Stern Y, Gurland B, Tatemichi TK, Tang MX, Wilder D., Mayeaux R. (1994) Influence of education and occupation on the incidence of Alzheimer's disease. J.A.M.A. 271(13): 1004-1010.
27. Miller ER, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Metaanalysis: High dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med 2004; 142:37-46.
28. Berry D, Wathen JK, Newell M. Bayesian model averaging in meta-analysis: vitamin E supplementation and mortality. Clinical Trials 2009; 6:28-41.
29. Abner EL, Schmitt FA, Mendiondo MS, Marcum JL, Kryscio RJ (2011) Vitamin E and All-cause mortality: a meta-analysis. Current Aging Science 4(2): 158-170.