A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia

JAMA

Volumn 278, Issue 16, 1997, Pages 1327-1332

  Le Bars, Pierre L ^a,f   Katz, Martin M ^b   Berman, Nancy ^c   Itil, Turan M ^d,f   Freedman, Alfred M ^d   Schatzberg, Alan F ^e,g  

^a New York Inst for Medical Research   (United States)

^b ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^c HARBOR UCLA MEDICAL CENTER   (United States)

^d NEW YORK MEDICAL COLLEGE   (United States)

^e Harvard Medical Center   (United States)

^f NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GINKGO BILOBA EXTRACT; PLACEBO;

ADULT; AGED; ALZHEIMER DISEASE; ARTICLE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIINFARCT DEMENTIA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOCIAL BEHAVIOR; STROKE; SUBDURAL HEMATOMA;

GINKGO BILOBA;

EID: 0030759072     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.278.16.1327     Document Type: Article

References (42)

1. Cott J. Natural product formulations available in Europe for psychotropic indication. Psychopharmacol Bull. 1995;31:745-751.
2. DeFeudis FG. In: DeFeudis FV, ed. Ginkgo Biloba Extract (EGb 761): Pharmacological Activities and Clinical Applications. Paris, France: Editions Scientifiques Elsevier; 1991:7-146.
3. Packer L, Haramaki N, Kawabata T, et al. Ginkgo biloba extract (EGb 761). In: Christen Y, Courtois Y, Droy-Lefaix MT, eds. Effect of Ginkgo Biloba Extract (EGb 761) on Aging and Age-Related Disorders. Paris, France: Editions Scientifiques Elsevier Paris; 1995:23-17.
4. 2+-loaded brain neurons. Brain Res. 1994;635:125-129.
5. Richardson JS. Free radicals in the genesis of Alzheimer's disease. In: Nitsch RM, Growdon JH, Corkin S, Wurtman RJ, volume eds. Alzheimer's Disease: Amyloid Precursor Proteins, Signal Transduction, and Neuronal Transplantation. Ann N Y Acad Sci. 1993;695:73-76.
6. Anderson DK, Thomas CE. Mechanisms and role of oxygen free radicals in CNS pathology. In: Racagni G, Brunello N, Langer SZ, volume eds. Recent Advances in the Treatment of Neurodegenerative Disorders and Cognitive Dysfunction. Int Acad Biomed Drug Res. 1994;7:119-124.
7. Behl C, Davis JB, Lesley R, Schubert D. Hydrogen peroxide mediates amyloid β protein toxicity. Cell. 1994;77:817-827.
8. Benzi G, Moretti A. Are reactive oxygen species involved in Alzheimer's disease? Neurobiol Aging. 1995;16:661-674.
9. Warburton DM. Psycho-pharmacologie clinique de l'extrait de Ginkgo biloba. Presse Med. 1986;15:1595-1604.
10. Kleijnen J, Knipschild P. Ginkgo biloba for cerebral insufficiency. Br J Clin Pharmacol. 1992;34: 352-358.
11. Letzel H, Haan J, Feil WB. Nootropics. J Drug Dev Clin Pract. 1996;8:77-94.
12. Hofferberth B. The efficacy of EGb 761 in patients with senile dementia of the Alzheimer type, a double-blind, placebo-controlled study on different levels of investigation. Hum Psychopharmacol. 1994; 9:215-222.
13. Kanowski S, Herrmann WM, Stephan K, Wierich W, Hörr R. Proof of efficacy of the Ginkgo biloba special extract EGb 761 in outpatients suffering from mild to moderate primary degenerative dementia of the Alzheimer type or multi-infarct dementia. Pharmacopsychiatry. 1996;29:47-56.
14. Folstein MF, Folstein SE, McHugh PR. Mini-Mental State. J Psychiatr Res. 1975;12:189-198.
15. Reisberg B, Ferris SH, de Leon MJ, et al. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982;39: 1136-1139.
16. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984; 141:1356-1364.
17. Stern RG, Mohs RC, Davidson M, et al. A longitudinal study of Alzheimer's disease. Am J Psychiatry. 1994;151:390-396.
18. Schwartz GE. Development and validation of the Geriatric Evaluation by Relative's Rating Instrument (GERRI). Psychol Rep. 1983;53:479-488.
19. Morich FJ, Bieber F, Lewis JM, et al. Nimodipine in the treatment of probable Alzheimer's disease. Clin Drug Invest. 1996;11:185-195.
20. Clinical Global Assessment Scale (CGI). In: Guy W, ed. ECDEU Assessment Manual for Psychopharmacology. Rockville, Md: US Dept of Health Education and Welfare, National Institute of Mental Health; 1976:218-222.
21. Gillings D, Koch G. The application of the principle of intention-to-treat to the analysis of clinical trials. Drug Inform J. 1991;25:411-424.
22. Jorm AF, Korten AE, Henderson AS. The prevalence of dementia. Acta Psychiatr Scand. 1987;76:465-479.
23. Katzman R, Lasker B, Bernstein N. Advances in the diagnosis of dementia. In: Terry RD, ed. Aging and the Brain. New York, NY: Raven Press; 1988: 17-62.
24. Anthony JC, LeResche L, Niaz U, Von Korff MR, Folstein MF. Limits of the 'Mini-Mental State' as a screening test for dementia and delirium among hospital patients. Psychol Med. 1982;12:397-408.
25. Crum RM, Anthony JC, Bassett SS, Folstein MF. Population-based norms for the Mini-Mental State Examination by age and education level. JAMA. 1993; 269:2386-2421.
26. Welsh K, Butters N, Hughes J, Mohs R, Heyman A. Detection of abnormal memory decline in mild cases of Alzheimer's disease using CERAD neuropsychological measures. Arch Neurol. 1991;48:278-281.
27. Agresti A. Tutorial on modeling ordered categorical response data. Psychol Bull. 1989;105:290-301.
28. Kramer-Ginsberg E, Mohs RC, Aryan M, et al. Clinical predictors of course for Alzheimer patients in a longitudinal study: a preliminary report. Psychopharmacol Bull. 1988;24:458-462.
29. Davis LK, Thai LJ, Gamzu ER, et al. A doubleblind, placebo-controlled multicenter study of tacrine for Alzheimer's disease. N Engl J Med. 1992;327:1253-1259.
30. Farlow M, Gracon SI, Hershey LA, et al. A controlled trial of tacrine in Alzheimer's disease. JAMA. 1992;268:2523-2529.
31. Knapp MJ, Knopman DS, Solomon PR, et al. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA. 1994;271:985-991.
32. Morris JC, McKeel DW, Fulling K, Torack RM, Berg L. Validation of clinical diagnosis criteria for Alzheimer's disease. Ann Neurol. 1988;24:17-22.
33. Baldereschi M, Amato MP, Nencini P, et al. Cross-national interrater agreement on the clinical diagnostic criteria for dementia. Neurology. 1994;44239-242.
34. Victoroff J, Mack WJ, Lyness SA, Chui HC. Multicenter clinicopathological correlation in dementia. Am J Psychiatry. 1995;152:1476-1484.
35. Dahlke F, Lohaus A, Gutzmann H. Reliability and clinical concepts underlying global judgments in dementia. Psychopharmacol Bull. 1992;28:425-432.
36. Knopman DS, Knapp MJ, Gracon SI, Davis CS. The Clinician Interview-Based Impression (CIBI): a clinician's global change rating scale in Alzheimer's disease. Neurology. 1994;44:2315-2321.
37. Itil TM, Eralp E, Tsambis E, Itil KZ, Stein U. Central nervous system effects of Ginkgo biloba, a plant extract. Am J Ther. 1996;3:63-73.
38. Leber P. Observations and suggestions on anti-dementia drug development. Alzheimer Dis Assoc Disord. 1996;10(suppl 1):31-35.
39. Chui H, Victoroff JI, Margolin D, Jagust W, Shankle R, Katzman R. Criteria for the diagnosis of ischemic vascular dementia proposed by the State of California Alzheimer Disease Diagnostic and Treatment Centers (ADDTC). Neurology. 1992;42: 473-480.
40. Lopez OL, Larumbe MR, Becker JT, et al. Reliability of NINDS-AIREN clinical criteria for the diagnosis of vascular dementia. Neurology. 1994;44: 1240-1245.
41. 2-Adrenoceptor change during cerebral ageing: the effect of Ginkgo biloba extract. J Pharm Pharmacol. 1992;44:24-27.
42. Krištofiková Z, Klaschka J. In vitro effect of Ginkgo biloba extract (EGb 761) on the activity of presynaptic cholinergic nerve terminals in rat hippocampus. Dement Geriatr Cogn Disord. 1997;8:43-48.