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

Volumn 29, Issue 2, 1996, Pages 47-56

  Kanowski, S ^a,d   Herrmann, W M ^a   Stephan, K ^b   Wierich, W ^b   Horr R ^c  

^a FREIE UNIVERSITÄT BERLIN   (Germany)

^b PAREXEL INTERNATIONAL   (United States)

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

^d CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

GINKGO BILOBA EXTRACT; PLACEBO;

ADULT; ALZHEIMER DISEASE; ARTICLE; BEHAVIOR; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEGENERATIVE DISEASE; DEMENTIA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERANCE; ELECTROENCEPHALOGRAM; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIINFARCT DEMENTIA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0029871249     PISSN: 01763679     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2007-979544     Document Type: Article

References (47)

1. Abt, K.: Significance testing of many variables. Neuropsychobiol. 9 (1983) 47-51
2. Abt, K.: Descriptive Data Analysis: A concept between confirmatory and exploratory data analysis. Meth. Informat. Med. 26 (1987) 77-88
3. Amaducci, L., J. Angst, P. Bech, O. Benkert, J. Bruinvels et al.: Consensus conference on the methodology of clinical trials of "Nootropics" Munich. Report of the Consensus Committee. Pharmacopsychiatry 23 (1990) 171-175
4. American Psychiatric Association: Diagnostic and statistical manual of mental disorders (3rd edn. rev.) DSM-III-R. Washington, DC, American Psychiatric Association, 1987
5. Anadere, I., H. Chmiel, S. Witte: Hemorheological findings in patients with completed stroke and the influence of a ginkgo biloba extract. Clinical Hemorheology 5 (1985) 411-420
6. Artmann, G., P. Michaelis, H. Schmid-Schönbein: Effect of ginkgo biloba extract 761 on microrheological parameters of red blood cells. Clin. Hemorheol. 9 (1989) 444
7. Barth, S. A., G. Inselmann, R., Engemann, H. T. Heidemann: Influences of ginkgo biloba on cyclosporin A induced lipid peroxidation in human liver microsomes in comparison to vitamin E, Gluthatione and N-Aceytlcysteine. Biochemical Pharmacology 41 (1991) 1521-1526
8. Chatterjee, S. S., B. Gabard: Protective effect of an extract of ginkgo biloba and other hydroxyl radical scavengers against hypoxia. Eighth International Congress of Pharmacology, Tokyo (1981), July 19-24, Abstracts, p. 483
9. Chatterjee, S. S., B. Gabard: Protection of Doxorubicin toxicity by an extract of ginkgo biloba. Naunyn-Schmiedeberg's Arch. Pharm. Suppl. 319, R 15, (1982) Abstr. 57
10. CIPS - Collegium Internationale Psychiatriae Scalarum (eds.): Internationale Skalen für Psychiatrie. Beltz-Test GmbH, Weinheim, 3rd edn. (1986)
11. CPMP Working Party on Efficacy of Medicinal Products: Note for Guidance. Good clinical practice for trials on medicinal products in the European Community. Office for Official Publications in the European Communities: Bruxelles - Luxembourg (1990)
12. CPMP Working Party on Efficacy of Medicinal Products: Note for guidance. Antidementia medicinal products. Commission of the European Communities, Brussels, III/3705-91-EN. Draft 5 (1992)
13. Dieli, G., V. LaMantia, M. Saetta, E. Costanzo: Studio clinico in doppio cieco del tanakan nell' insufficienza cerebrale cronica. Il Lavoro Neuropsichiatrico 68 (1981) 3-15
14. Eckmann, F., H. Schlag: Kontrollierte Doppelblind-Studie zum Wirksamkeitsnachweis von Tebonin forte bei Patienten mit zerebrovaskulärer Insuffizienz (Controlled double-blind study to test the efficacy of Tebonin forte in patients with cerebrovascular insufficiency). Fortschritte der Medizin 100 (1982) 1474-1478
15. Erzigkeit, H.: Der Syndrom-Kurztest zur Erfassung von Aufmerksamkeits- und Gedächtnisstörungen (The syndrome short-test for the assessment of disturbed concentration and memory). Vaterstetten (F.R.G.): Vless-Verlagsgesellschaft (1986)
16. FDA Antidementia Drug Assessment Symposium, Rockville, Md.: Department of Health and Human Services. Public Health Service, Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Panel. Antidementia Drug Assessment Symposium, Vol. II. Washington. D.C., Miller Reporting Co., Inc., 1989
17. Folstein, M. F., S. E. Folstein, P. R. McHugh: "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J. Psychiat. Res. 12 (1975) 189-198
18. Fröstl, W., L. Maître: The families of cognition enhancers. Pharmacopsychiatry 22 (1989) 54-100
19. Halama, P., G. Bartsch, G. Meng: Hirnleistungsstörungen vaskulärer Genese. Randomisierte Doppelblindstudie zur Wirksamkeit von Gingko-biloba-Extrakt. (Impaired brain functions of vascular origin. Randomized double-blind study of ginkgo biloba extract.) Fortschr. Med. 106 (1988) 408-412
20. Heiss, W. D., K. Zeiler: Medikamentöse Beeinflussung der Hirndurchblutung (Drug influence on cerebral circulation). Pharmakotherapie 1 (1978) 137-144
21. Hofferberth, B.: Einfluß von Ginkgo-biloba-Extrakt auf neurophysiologische und psychometrische Meßergebnisse bei Patienten mit hirnorganischem Psychosyndrom. Eine Doppelblindstudie gegen Placebo (Influence of ginkgo biloba extract on neurophysiological and psychometric results of assessment in patients with organic psychosyndrome). Arzneim.-Forsch./Drug Res. 39 (1989) 918-922
22. Hofferberth, B.: Simultanerfassung elektrophysiologischer, psychometrischer und rheologischer Parameter bei Patienten mit hirnorganischem Psychosyndrom und erhöhtem Gefäßrisiko - Eine placebokontrollierte Doppelblindstudie mit Ginkgo-biloba-Extrakt EGb 761 (Simultaneous evaluation of electrophysiological, psychometric and rheological parameters in patients with organic psychosyndrome and increased vessel risk. A placebo-controlled double-blind study with ginkgo biloba). In: Stodtmeister, R. und Pillunat L. E. (eds.), Mikrozirkulation in Gehirn und Sinnesorganen (Micro-circulation of brain and sensory organs). Enke. Stuttgart. (1991) 64-74
23. Ihl, R., T. Dierks, E. Martin, L. Frölich, K. Maurer: Ginkgo-biloba-Extrakt EGb 761 bei der Demenz vom Alzheimer Typ (Ginkgo biloba extract in dementia of the Alzheimer type). 15. Donau-symposium f. Psychiatrie (1992) Abstract N1.40
24. Israël, L., E. Dell'Accio, G. Martin, R. Hugonot: Extrait de Ginkgo biloba et exercises d'entrainement de la mémoire. Psychologie Médicale 19 (1987) 1431-1439
25. Kanowski, S., G. Ladurner, K. Maurer, W. D. Oswald, U. Stein: Outline for the evaluation of nootropic drugs. In: K. Maurer, P. Riederer, H. Beckmann (Eds.), Alzheimer's disease, epidemiology, neuropathology, neurochemistry, and clinics (1990) pp. 531-543. Wien - New York: Springer-Verlag
26. Knapp, M. J., D. S. Knopman, P. R. Solomon, W. W. Pendlebury, C. S. Davis, S. I. Gracon: A 30-week randomized controlled trial of high-dose Tacrine in patients with Alzheimer's disease. JAMA 241 (1994) 985-991
27. Kim, Y. S., D. W. Nibbelink, J. E. Overall: Factor structure and scoring of the SKT test battery. J. Clin. Psychol. 49 (1993) 61-71
28. Kleijnen, J., P. Knipschild: Ginkgo biloba for cerebral insufficiency. Br. J. of Clin. Pharmacol. 34 (1992) 352-358
29. Leber, P.: Guidelines for the clinical evaluation of antidementia drugs. 1st draft, available from the FDA, November 8 (1990)
30. Költringer, P., O. Eber, P. Lind, W. Langsteger, P. Wakonig, G. Klima, W. Rothlauer: Mikrozirkulation und Viskoelastizität des Vollblutes unter Ginkgo-biloba-Extrakt. Eine plazebokontrollierte, randomisierte Doppelblind-Studie (Microcirculation and viscoelasticity of whole blood under ginkgo biloba extract. A placebo-controlled, randomised double-blind study). Perfusion 1 (1989) 28-30
31. Kristofiková, Z., O. Benesová, H. Tejkalová: Changes of high-affinity choline uptake in the hippocampus of old rats after long-term administration of two nootropic drugs (Tacrine and Ginkgo biloba Extract). Dementia 3 (1992) 304-307
32. Leroy, M., P. Salaün, R. Chovelon, E. Bouilloux: Approche clinique et psychométrique en gériatrie. Méthodes d'études et choix d'une thérapeutique. Vie Médicale 28 (1978) 2513-2519
33. Ministry of Youth, Family, Women and Health: Bekanntmachung von Grundsätzen für die ordnungsgemäße Durchführung der klinischen Prüfung von Arzneimitteln vom 9. Dezember 1987 (Principles for the proper conduct of clinical studies with medicinal products). BAnz. (1987) p. 16617
34. Moreau, Ph.: Un nouveau stimulant circulatoire cérébral. La Nouvelle Presse Médicale 4 (1975) 2401-2402
35. NIMH National Institute of Mental Health: Clinical global impression (CGI). In: Guy, W., R. Bonato (Hrsg.): Manual for the ECDEU assessment battery. 2nd rev. edn., Chevy Chase, Md. (1970) 12.1.-12.6.
36. Overall, J. E., R. Schaltenbrand: The SKT neuropsychological test battery. J. Geriat. Psychiat. Neurol. 5 (1992) 220-227
37. Oswald, W. D., U. M. Fleischmann: Nürnberger-Alters-Inventar (NAI: Nuremberg Age Inventory). Universität Erlangen-Nürnberg, Psychologisches Institut 11 (1986)
38. Pincemail, J., M. Dupuis, C. Nasr, P. Hans, M. Haag-Berrurier, R. Anton, C. Deby: Superoxide anion scavenging effect and superoxide dismutase activity of Ginkgo biloba extract. Experientia 45 (1989) 708-712
39. Rosen, W. G., R. D. Terry, P. D. Fuld, R. Katzmann, A. Peck: Pathological verification of ischemic score in differentiation of dementias. Ann. Neurol. 7 (1980) 486-488
40. Steinwachs, K. C., H. Lehfeld, J. Jentzsch, H. Erzigkeit: Evaluation of the clinical relevance and therapy sensitivity of 32 ADL - and behaviour rating scales for dementia - Part I: Posing the problem and preliminary results of an expert-rating. Z. Gerontopsychol. & -psychiat. 6 (1993) 241-253
41. Taillandier, J., A. Ammar, J. P. Rabourdin, J. P. Ribeyre, J. Pichon, S. Niddam, H. Pierart: Traitement des troubles du vieillissement cérébral par l'extrait de Ginkgo biloba. Etude longitudinale multicentrique à double insu face au placebo. La Presse Médicale 15 (1986) 1583-1587
42. Taylor, J. E.: Liaison des neuromédiateurs à leurs récepteurs dans le cerveau de rats. La Presse Médicale 15 (1986) 1491-1493
43. Tea, S., P. Celsis, M. Clanet, J.-P. Marc-Vergnes, U. Boeters: Quantifizierte Parameter zum Nachweis von cerebraler Durchblutungs-und Stoffwechselsteigerung unter Ginkgo-biloba-Therapie (Quantified parameters for the proof of the enhancement of cerebral circulation and metabolism). Therapiewoche 37 (1987) 2655-2657
44. Weitbrecht, W.-U., W. Jansen: Primär degenerative Demenz: Therapie mit Ginkgo-biloba-Extrakt. Placebokontrollierte Doppel-blind- und Vergleichsstudie (Therapy with ginkgo biloba extract. Placebo-controlled double-blind and comparative study). Fortschr. Med. 104 (1986) 199-202
45. Winter, E.: Effects of an extract of Ginkgo biloba on learning and memory in mice. Pharmacol. Biochem. and Behaviour 38 (1991) 109-114
46. Warburton, D. M.: Psycho-pharmacologie clinique de l'extrait de Ginkgo biloba. (Clinical psychopharmacology of Ginkgo biloba extract.) Presse Medicale 15 (1986) 1595-1604
47. Witte, S., I. Anadere, W. Walitza: Verbesserung der Hämorheologie durch Ginkgo-biloba-Extrakt. Verminderung des kardiovaskulären Risikofaktors (Improvement of haemorheology by ginkgo biloba extract. Reduction of the cardiovascular risk factor). Fortschritte der Therapie 13 (1992) 247-250