A 26-week analysis of a double-blind, placebo-controlled trial of the Ginkgo biloba extract EGb 761® in dementia

Dementia and Geriatric Cognitive Disorders

Volumn 11, Issue 4, 2000, Pages 230-237

  Le Bars, Pierre L ^a   Kieser, Meinhard ^c   Itil, Kurt Z ^b  

^a Memory Centers of America   (United States)

^b NeuroTrax Corporation   (United States)

^c DR WILLMAR SCHWABE GMBH AND CO KG   (Germany)

Author keywords

Alzheimer's disease; Dementia; EGb 761 ; Geriatric Evaluation by Relative's Rating Instrument; Ginkgo biloba; Randomized controlled trial

Indexed keywords

GINKGO BILOBA EXTRACT;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DEMENTIA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; SIDE EFFECT; SOCIAL BEHAVIOR;

EID: 0034125340     PISSN: 14208008     EISSN: None     Source Type: Journal    
DOI: 10.1159/000017242     Document Type: Article

References (22)

1. Leber P: Observations and suggestions on anti-dementia drug development. Alzheimer Dis Assoc Disord 1996;10(suppl 1):31-35.
2. Whitehouse PJ, Kittner B, Roessner M, Rossor M, Sano M, Thal L, Winblad B: Clinical trial designs for demonstrating disease-course-altering effects in dementia. Alzheimer Dis Assoc Disord 1998;12:281-294.
3. 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.
4. Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF: A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. JAMA 1997;278:1327-1332.
5. Knapp MJ, Knopman DS, Solomon PR, Pendlebury WW, Davis CS, Gracon SI: A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA 1994;271:985-991.
6. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT: A 24-week, double blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology 1998;50:136-145.
7. Kleijnen J, Knipschild P: Ginkgo biloba for cerebral insufficiency. Br J Clin Pharmacol 1992;34:352-358.
8. Letzel H, Haan J, Feil WB: Nootropics: Efficacy and tolerability of products from three active substance classes. J Drug Dev Clin Pract 1996;8:77-94.
9. DeFeudis FV (ed): Ginkgo bilobia Extract (EGb 761): From Chemistry to the Clinic. Wiesbaden, Ullstein Medical, 1998.
10. Rosen WG, Mohs RC, Davis KL: A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141:1356-1364.
11. Schwartz GE: Development and validation of the Geriatric Evaluation by Relative's Rating Instrument (GERRI). Psychol Rep 1983;53: 479-488.
12. Clinical Global Assessment Scale (CGI): in Guy W (ed): ECDEU Assessment Manual for Psychopharmacology. Rockville, US Department of Health Education and Welfare, National Institute of Mental Health, 1976, pp 218-222.
13. Gillings D, Koch G: The application of the principle of intention-to-treat to the analysis of clinical trials. Drug Inf J 1991;25:411-424.
14. 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.
15. Stern RG, Mohs RC, Davidson M, Schmeidler J, Silverman J, Kramer-Ginsberg E, Searcey T, Bierer L, Davis KL: A longitudinal study of Alzheimer's disease: Measurement, rate, and predictors of cognitive deterioration. Am J Psychiatry 1994;151:390-396.
16. Agresti A: Tutorial on modeling ordered categorical response data. Psychol Bull 1989;105: 290-301.
17. Rother M, Erkinjuntti T, Roessner M, Kittner B, Marcusson J, Karlsson I: Propentofylline in the treatment of Alzheimer's disease and vascular dementia: A review of phase III trials. Dement Geriatr Cogn Disord 1998;9(suppl 1): 36-43.
18. 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.
19. Roman GC, Tatemichi TK, Erkinjuntti T, Cummings JL, Masdeu JC, Garcia JH, et al: Vascular dementia: Diagnostic criteria for research studies. Report of the NINDS-AIREN International Workshop. Neurology 1993;43: 250-260.
20. Snowdon DA, Greiner LH, Mortimer JA, Riley KP, Greiner PA, Markesbery WR: Brain infarction and the clinical expression of Alzheimer disease. JAMA 1997;277:813-817.
21. Wallin A: The overlap between Alzheimer's disease and vascular dementia: The role of white matter changes. Dement Geriatr Cogn Disord 1998;9(suppl 1):30-35.
22. Morich FJ, Richer F, Lewis JM, Kaiser L, Cutler NR, Escobar JI, Willmer J, Petersen RC, Reisberg B: Nimodipine in the treatment of probable Alzheimer's disease. Results of two multicenter trials. Clin Drug Invest 1996;11: 185-195.