Long-term nicergoline treatment of mild to moderate senile dementia. Results of a multicentre, double-blind, placebo-controlled study

Clinical Drug Investigation

Volumn 13, Issue 6, 1997, Pages 308-316

  Nappi, Giuseppe ^a   Bono, Giorgio ^a   Merlo, Paola ^a   Borromei, Alessandro ^b   Caltagirone, Carlo ^c   Lomeo, Cirino ^d   Martucci, Nicola ^e   Fabbrini, Giovanni ^f   Annoni, Karin ^g   Battaglia, Angelo ^g  

^a UNIVERSITY OF PAVIA   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c UNIVERSITY OF ROME TOR VERGATA   (Italy)

^d UNIVERSITY OF CATANIA   (Italy)

^e INI   (Italy)

^f SAPIENZA UNIVERSITY OF ROME   (Italy)

^g PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NICERGOLINE;

ADULT; AGED; ARTICLE; BEHAVIOR; CAREGIVER; CLINICAL TRIAL; CLUSTER ANALYSIS; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GASTRITIS; HEADACHE; HOT FLUSH; HUMAN; MAJOR CLINICAL STUDY; MALE; MENTAL HEALTH; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENILE DEMENTIA; TREATMENT OUTCOME;

EID: 8544240160     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-199713060-00003     Document Type: Article

References (36)

1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Association, 1994
2. Amaducci L, Lippi A. The epidemiology of senile dementia in Europe. Eur J Geront 1991; 2: 69-72
3. Max W. The cost of Alzheimer's disease: will drug treatment ease the burden? PharmacoEconomics 1996; 9: 5-10
4. Schneider I.S. Efficacy of treatment for gerontopsychiatric patients with severe mental illness. Psychopharmacol Bull 1993; 29 (4): 501-24
5. Wagstaff AJ, McTavish D. Tacrine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in Alzheimer's disease. Drugs Aging 1994; 4 (6): 510-40
6. Gottfries CG. Clinical and neurochemical aspects of diseases with cognitive impairment. Rev Neurosci 1992; 3: 191-206
7. Paul A, Chandra P. Einflusse Ion Nicergoline auf molekular-biologische Prozesse im Gehirn un seine Auswirkung auf die Lehrnfahigkeit der Ratte. Arzneimittelforschung 1979; 29: 1238-51
8. Chandra P, Paul A. The effects of nicergoline and other vasoactive substances on molecular biological processes in the brain and their effects on the learning abilities of rats. In: Heidrich H, editor. Proof of therapeutical effectiveness of nootropie and vasoactive drugs. Berlin: Springer-Verlag, 1985: 119-30
9. Moretti A, Carfagna N, Caccia C, et al. Neurochemical effects of ergoline derivatives. In: Heidrich H, editor. Proof of therapeutic effectiveness of nootropic and vasoactive drugs. Berlin: Springer-Verlag, 1985: 103-10
10. Matsuoka Y, Fukusima T, Iwata H, et al. Inhibitory action of nicergoline and its major metabolites on acetylcholinesterase activity in rat and mouse brain. In: Nagatsu T, editor. Basic, clinical and therapeutic aspects of Alzheimer's and Parkinson's disease. New York: Plenum Press, 1990: 415-9
11. Ogawa N, Asanuma M, Hirnta H, et al. Cholinergic deficits in aged rat brain are corrected with nicergoline. Arch Gerontol Geriatr 1943; 16: 103-10
12. Carfagna N, Cavanus S, Caccia C, et al. Effect of nicergoline (Sermion®) on basal and agonist-stimulated phosphoinositide turnover in the rat brain. Pharmacol Res 1992; 26 Suppl. 1: 64
13. Cattabeni F. Protein chinase C in synaptic plasticity: a molecular target in the treatment of cognitive disorders. In: Fourth International Nice-Springfield Symposium on Advances in Alzheimer Therapy. Nice: 1996: April 10th-14th
14. Ladurner G, Erhart P, Erhart C, et al. Therapie des hirnorganischen Psychosyndroms mit Nicergolin in täglicher Einmalgabe. Wien Klin Wochenschr 1991; 103: 293-9
15. Canonico PL, Cavallaro S, D'Agata V, et al. Pharmacological basis for the clinical effects of nicergoline in dementia: protective action in vitro models of neurodegeneration [abstract]. Proceedings of the First European Congress of Pharmacology. Milan, Italy: 1995; Jun 16-19
16. Le Poncin-Lafitte M, Grosdemouge C, Billon C, et al. Simultaneous study of haemodynamic, metabolic and behavioural sequelae in a model of cerebral ischaemia in aged rats: effect of nicergoline. Gerontology 1984; 30 (2): 109-19
17. Voronina TA, Nerobkova LN, Garibova TL, et al. Effect of nicergoline on learning and memory. Meth Find Exp Clin Pharmacol 1988; 10: 431-5
18. McArthur RA, Cervini MA, Carfagna N. Nicergoline reverses the learning deficits in the radial maze of the aged rats. Proceedings of the 1993 Summer Meeting of the British Association of Psychopharmacology. 1993 July 25-28, Cambridge, England
19. Venn RD. The Sandoz Clinical Assessment Geriatric (SCAG) scale: a general purpose psychogeriatric rating scale. Gerontology 1983; 24: 185-98
20. Arrigo A, Moglia A, Borsotti L, et al. A double blind placebo-controlled cross-over trial with nicergoline in patients with senile dementia. Int J Clin Pharmacol 1982; 2 Suppl. 1: 33
21. Battaglia A, Bruni G, Ardia A, et al. A multicentre double-blind placebo-controlled study of nicergoline in mild to moderate dementia. J Am Geriatr Soc 1989; 37: 295-302
22. Nicergoline Cooperative Study Group. A double-blind randomised study of two ergot derivatives in mild to moderate dementia. Curr Ther Res 1990; 48: 597-622
23. Moglia A, Arrigo A. Ergot derivatives in the ageing brain: correlation between EEG spectral analysis and clinical findings. Funct Neurol 1989; 4: 23-6
24. Zappoli R, Arnetoli G, Paganini M, et al. Topographic bitmapped event-related neurocognitive potentials and clinical status in patients with primary presenile mental decline chronically treated with nicergoline. Curr Ther Res 1991; 49: 1078-97
25. Herrman WM, Kurt S, Gaede K, et al. A multicenter randomized double-blind study on the efficacy and safely of nicergoline in patients with multi-infarct dementia. Dement Geriatr Cogn Disord 1997; 8: 9-17
26. Saletu B, Paulus E, Linzmayer L, et al. Double-blind placebo-controlled clinical and EEG mapping studies with nicergoline in SDAT and MID. Psychopharmacology 1995; 117: 385-45
27. McKhann G, Drachman D, Folstein M, et al. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task force on Alzheimer's Disease. Neurology 1984; 34: 939-44
28. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 3rd ed. Washington, DC: American Psychiatric Association, 1988
29. Hachinski VC, Hiff LD, Phil M, et al. Cerebral Mood flow in dementia. Arch Neurol 1975; 32: 632-7
30. Reisberg B, Ferris SH, de Leon MJ, et al. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry 1982; 139: 1136-9
31. Folstein MF, Folstein SE, McHugh PR. Mini mental state: a practical method tor grading the cognitive state of patients for the clinicians. J Psychiat Res 1975; 12: 189-98
32. Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967; 6: 278-96
33. Department of Health and Human Services Public Health Service. Peripheral and Central Nervous System Drugs Advisory Committee meeting July 7, 1989. Rockville, Maryland: Food and Drug Administration, 1989; 227
34. Mortimer JA, Ebbitt B, Jun SP, et al. Predictors of cognitive and functional progression in patients with probable Alzheimer's disease. Neurology 1992; 42: 1689-96
35. Morris JC, Edland S, Clark C, et al. The consortium to establish a registry for Alzheimer's disease (CERAD). Part IV. Rates of cognitive change in the longitudinal assessment of probable Alzheimer's disease. Neurology 1993; 43: 2457-65
36. Forette F, Panisset M, Boller F. Clinical trials in cognitive impairment in the elderly. Aging 1992; 4: 239-50