A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease

Neurology

Volumn 68, Issue 1, 2007, Pages 20-28

  Kieburtz, Karl ^a,az   Ravina, Bernard ^a,b   Galpern, Wendy R ^b   Tilley, Barbara ^c   Shannon, Kathleen ^d   Tanner, Caroline ^e   Wooten, G Frederick ^f   Hamill, Robert ^g   Sage, Jacob I ^h   Kosa, Emily ^h   Watts, Ray L ⁱ   Stover, Natividad R ⁱ   McMurray, Rebecca ⁱ   Lew, Mark F ^j   Kawai, Connie ^j   Coffey, David ^k   LeBlanc, Pauline ^k   Carter, Julie ^l   Brodsky, Matthew ^l   Andrews, Pamela ^l   Siderowf, Andrew ^m   Reichwein, Sue ^m   Shulman, Lisa ⁿ   Weiner, William J ⁿ   Pabst, Katharine ⁿ   Jaglin, Jeana ^d   Hauser, Robert ^o   McClain, Theresa ^o   Delgado, Holly ^o   Suchowersky, Oksana ^p   Derwent, Lorelei ^p   Rao, Jayaraman ^q   Cook, Maureen ^q   Aminoff, Michael J ^r   Christine, Chad ^r   Roth, Jessie ^r   Leehey, Maureen ^s   Bainbridge, Jacci ^s   Ross, G Webster ^t   Terashita, Stephanie ^t   Singer, Carlos ^u   Perez, Marian A ^u   Blenke, Anita ^u   Racette, Brad ^v   Deppen, Patricia ^v   Elble, Rodger ^w   Young, Charlene ^w   Stewart, Tracy ^e   Sethi, Kapil ^x   Dill, Buff ^x   Taylor, John ^y   Roberge, Peggy ^y   Dewey Jr , Richard B ^z   Hayward, Brigid ^z   Jankovic, Joseph ^aa   Hunter, Christine ^aa   Wooten, Frederick ^f   Keller, Margaret F ^f   Jennings, Danna ^ab   Kelsey, Tammie ^ab   Martin, Wayne ^ac   McInnes, Germaine ^ac   Wojcieszek, Joanne ^ad   Belden, Joann ^ad   Albin, Roger ^ae   Wernette, Kristine ^ae   Savitt, Joseph ^af   Dunlop, Becky ^af   Pahwa, Rajesh ^ag   Lyons, Kelly E ^ag   Parsons, Amy ^ag   Fang, John ^ah   Shearon, Dorothy ^ah   Feigin, Andrew ^ai   Cox, Margaret Marie ^ai   Adler, Charles ^aj   Lind, Marlene ^aj   Scott, Burton ^ak   Field, Joanne ^ak   Nance, Martha ^al   Peterson, Susan ^al   Burns, Richard S ^am   Marlor, Lynn ^am   Van Bodis Wollner, I ^an   Hayes, Elizabeth ^an   Schneider, Jay ^ao   Sendek, Stephanie ^ao   Gollomp, Stephen ^ao   Vernon, Gwyn ^ao   LeWitt, Peter ^ap   DeAngelis, Maryan ^ap   Simon, David ^aq   Paul, Linda ^aq   Gorell, Jay ^ar   Krstevska, Shana ^ar   Flewellen, Marilyn ^ar   McCarthy, Sharon ^ar   Uitti, Ryan ^as   Turk, Margaret ^as   Bower, James ^at   Torgrimson, Susan ^at   Sabbagh, Marwan ^au   Obradov, Zoran ^au   Juncos, Jorge ^av   Weeks, Mary Louise Musante ^av   Fernandez, Hubert ^aw   Brown, Gordon ^aw   Elm, Jordan ^c   Guimaraes, Paulo ^c   Huang, Peng ^c   Palesch, Yuko ^c   Kamp, Cornelia ^a   Shinaman, Aileen ^a   Fraser, Debbie ^a   Brocht, Alicia ^a   Bennett, Susan ^a   Weaver, Chris ^a   Baker, Debbie ^a   Olsen, Beverly ^a   Goetz, Christopher ^d   Miyasaki, Janis ^ax   Fagan, Susan ^ay   Mauldin, Patrick ^c   more..

^a UNIVERSITY OF ROCHESTER   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d RUSH UNIVERSITY   (United States)

^e PARKINSON S INSTITUTE   (United States)

^f UNIVERSITY OF VIRGINIA   (United States)

^g UNIVERSITY OF VERMONT   (United States)

^h ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

ⁱ UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^j UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^k DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^l OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^m UNIVERSITY OF PENNSYLVANIA   (United States)

ⁿ UNIVERSITY OF MARYLAND   (United States)

^o UNIVERSITY OF SOUTH FLORIDA   (United States)

^p UNIVERSITY OF CALGARY   (Canada)

^q LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^r UNIVERSITY OF CALIFORNIA   (United States)

^s UNIVERSITY OF COLORADO   (United States)

^t PACIFIC HEALTH RESEARCH INSTITUTE   (United States)

^u UNIVERSITY OF MIAMI   (United States)

^v WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^w SOUTHERN ILLINOIS UNIVERSITY   (United States)

^x MEDICAL COLLEGE OF GEORGIA   (United States)

^y VETERANS AFFAIRS MEDICAL CENTER   (United States)

^z UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^aa BAYLOR COLLEGE OF MEDICINE   (United States)

^ab INSTITUTE FOR NEURODEGENERATIVE DISORDERS   (United States)

^ac UNIVERSITY OF ALBERTA   (Canada)

^ad INDIANA UNIVERSITY   (United States)

^ae UNIVERSITY OF MICHIGAN   (United States)

^af JOHNS HOPKINS UNIVERSITY   (United States)

^ag UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

^ah VANDERBILT UNIVERSITY   (United States)

^ai NORTH SHORE UNIVERSITY HOSPITAL   (United States)

^aj MAYO CLINIC   (United States)

^ak DUKE UNIVERSITY   (United States)

^al Struthers Parkinson's Center   (United States)

^am BARROW NEUROLOGICAL INSTITUTE   (United States)

^an SUNY DOWNSTATE MEDICAL CENTER   (United States)

^ao THOMAS JEFFERSON UNIVERSITY   (United States)

^ap WILLIAM BEAUMONT HOSPITAL   (United States)

^aq BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^ar HENRY FORD HEALTH SYSTEM   (United States)

^as MAYO CLINIC   (United States)

^at MAYO CLINIC ROCHESTER   (United States)

^au SUN HEALTH RESEARCH INSTITUTE   (United States)

^av EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^aw UNIVERSITY OF FLORIDA   (United States)

^ax TORONTO WESTERN HOSPITAL   (Canada)

^ay UNIVERSITY OF GEORGIA   (United States)

^az UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GPI 1485; PLACEBO; UBIQUINONE;

CALIBRATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG COST; HUMAN; OUTCOME ASSESSMENT; PARKINSON DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; UNIFIED PARKINSON DISEASE RATING SCALE;

EID: 33846115045     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.wnl.0000250355.28474.8e     Document Type: Article

References (44)

1. Ravina BM, Fagan SC, Hart RG, et al. Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology 2003;60:1324-1340.
2. Beyer RE. An analysis of the role of coenzyme Q in free radical generation and as an antioxidant. Biochem Cell Biol 1992;70:390-403.
3. Do TQ, Schultz JR, Clarke CF. Enhanced sensitivity of ubiquinone-deficient mutants of saccharomyces cerevisiae to products of autoxidized polyunsaturated fatty acids. Proc Natl Acad Sci USA 1996;93:7534-7539.
4. Forsmark-Andree P, Lee C-P, Dallner G, Ernster L. Lipid peroxidation and changes in the Ubiquinone content and the respiratory chain enzymes of submitochondrial particles. Free Radical Biology Med 1997;22:391-400.
5. Noack H, Kube U, Augustin W. Relations between tocopherol depletion and coenzyme Q during lipid peroxidation in rat liver mitochondria. Free Radical Research 1994;20:375-386.
6. Abou-Sleiman PM, Muqit MMK, Wood NW. Expanding insights of mitochondrial dysfunction in Parkinson's disease. Nat Rev Neurosci 2006;7:207-219.
7. Schapira AH, Cooper JM, Dexter D, Clark JB, Jenner P, Marsden CD. Mitochondrial complex I deficiency in Parkinson's disease. J Neurochem 1990;54:823-827.
8. Shults CW, Haas RH, Passov D, Beal MF. Coenzyme Q10 levels correlate with the activities of complexes 1 and II/III in mitochondria from Parkinsonian and nonparkinsonian subjects. Ann Neurol 1997;42:261-264.
9. Matsubara T, Azuma T, Yoshida S, Yamagami T. Serum coenzyme Q10 level in Parkinson syndrome. In: Fokers K, Littarru GP, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q. New York, NY: Elsevier Science Publishers, 1991:159-166.
10. Beal MF, Matthews RT, Tieleman A, Shults CW. Coenzyme Q10 attenuates the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) induced loss of striatal dopamine and dopaminergic axons in aged mice. Brain Res 1998;783:109-114.
11. Ferrante RJ, Andreassen OA, Dedeoglu A, et al. Therapeutic effects of coenzyme Q10 and remacemide in transgenic mouse models of Huntington's disease. J Neurosci 2002;22:1592-1599.
12. Shults CW, Oakes D, Kieburtz K, et al. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol 2002;59:1541-1550.
13. Shults CW, Beal FM, Song D, Fontaine D. Pilot trial of high dosages of coenzyme Q10 in patients with Parkinson's disease. Exp Neurol 2004;188:491-494.
14. Snyder SH, Sabatini DM. Immunophilins and the nervous system. Nat Med 1995;1:32-37.
15. Steiner JP, Dawson TM, Fotuhi M, et al. High brain densities of the immunophilin FKBP colocalized with calcineurin. Nature 1992;358:584-587.
16. Lyons WE, George EB, Dawson TM, Steiner JP, Snyder SH. Immunosuppressant FK506 promotes neurite outgrowth in cultures of PC12 cells and sensory ganglia. Proc Natl Acad Science USA 1994;91:3191-3195.
17. Gold BG, Zeleny-Pooley BS, Wang MS, Chaturvedi P, Armistead DM. A nonimmunosuppressant FKBP-12 ligand increases nerve regeneration. Exp Neurol 1997;147:269-278.
18. Steiner JP, Hamilton GS, Ross DT, et al. Neurotrophic immunophilin ligands stimulate structural and functional recovery in neurodegenerative animal models. Proc Natl Acad Science USA 1997;94:2019-2024.
19. Gold BG, Zeleny-Pooley M, Chaturvedi P, Wang MS. Oral administration of a nonimmunosuppressant FKBP-12 ligand speeds nerve regeneration. Neurol Rep 1998;9:553-558.
20. Sabatini DM, Lai MM, Snyder SH. Neural roles of immunophilins and their ligands. Molec Neurobiol 1997;15:223-229.
21. Snyder SH, Sabatini DM, Lai MM, Steiner JP, Hamilton GS, Suzdak PD. Neural actions of immunophilin ligands. Trends Pharmacol Science 1998;19:21-26.
22. Poulter MO, Payne KB, Steiner JP. Neuroimmunophilins: a novel drug treatment for the reversal of neurodegenerative disease? Neuroscience 2004;128:1-6.
23. The NINDS NET-PD Investigators. A randomized, double blinded, futility clinical trial of creatine and minocycline in early Parkinson's disease. Neurology 2006;66:664-671.
24. Tilley BC, Palesch YY, Kieburtz K, et al. Optimizing the ongoing search for new treatments for Parkinson's disease: using futility designs. Neurology 2006;66:628-633.
25. Herson J, Carter SK. Calibrated phase II clinical trials in oncology. Stat Med 1986;5:441-447.
26. Elm JJ, Ravina B, Shannon K, et al. A responsive outcome for Parkinson's disease neuroprotection futility studies. Ann Neurol 2005;57:197-203.
27. Fahn S, Elton RL, members of the UP DRS Development Committee. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CO, Calne DB, Goldstein M, eds. Recent developments in Parkinson's disease. Florham Park, NJ: Macmillan Health Care Information, 1987:153-163.
28. Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology 1967;17:427-442.
29. Schwab RS, England AC Jr. Projection technique for evaluating surgery in Parkinson's disease. In: Gillingham FJ, Donaldson IM, eds. Third Symposium on Parkinson's Disease held at the Royal College of Surgeons of Edinburgh on 21 and 22 May 1986. Edinburgh, Scotland: E & S Livingstone, 1969:152-157.
30. Meara J, Mitchelmore E, Hobson P. Use of the GDS-15 geriatric depression scale as a screening instrument for depressive symptomatology in patients with Parkinson's disease and their careers in the community. Age Aging 1999;28:35-38.
31. Van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988;19:604-607.
32. Shoulson I, Kurlan R, Rugin RJ, et al. Assessment of functional capacity in neurodegenerative movement disorders: Huntington's disease as a prototype. Munsat T, ed. Quantification of neurologic deficit. Stoneham: Butterworths, 1989.
33. Ferraro FR, Chelminski I. Preliminary normative data on the Geriatric Depression Scale-Short Form (GDS-SF) in a young adult sample. J Clin Psychol 1996;52:443-447.
34. Jenkinson C, Pitzpatrick R, Peto V. The Parkinson's disease questionnaire. User manual for the PDQ-39, PDQ-8 and PDQ Summary Index. Oxford: Health Services Research Unit, Department of Public Health, University of Oxford: 1998. Americanized version adapted by Bushnell DM, Mortin ML, 1999.
35. Randolph C. RBANS manual-Repeatable Battery for the Assessment of Neuropsychological Status. San Antonio, TX: Psychological Corp (Harcourt), 1998.
36. Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB. A frontal assessment battery at bedside. Neurology 2000;55:1621-1626.
37. Wechsler D. WMS-II Administration and Scoring Manual. The Psychological Corporation. San Antonio, TX: Harcourt, Brace and Company, 1997.
38. The Parkinson Study Group. Effect of deprenyl on the progression of disability in early Parkinson's disease. N Engl J Med 1989;321:1364-1371.
39. Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chron Dis 1976;29:175-188.
40. Friedman L, Furberg C, DeMets D. Fundamentals of clinical trials. 2nd ed. Littleton, MA: John Wright-PSG Inc., 1985:94.
41. The Parkinson Study Group PRECEPT Investigators. Baseline comparison of the PRECEPT and DATATOP Clinical Trial Cohorts (abstract). Mov Disord 2006;21(suppl 13):S121.
42. Levy G, Kaufmann P, Buchsbaum R, et al. A two-stage design for a phase II clinical trial of coenzyme Q10 in ALS. Neurology 2006;66:660-663.
43. Miller ER III, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med 2005;142:37-46.
44. Marras C, Lang AE, Oakes D, et al. Letter to the editor. Ann Intern Med 2005;143:152-153.