A Multicenter Randomized Double-Blind Study on the Efficacy and Safety of Nicergoline in Patients with Multi-lnfarct Dementia

Herrmann, W. M.; Stephan, K.; Gaede, Konrad; Apeceche, Mercedes

doi:10.1159/000106595

Cited by 53 publications

(18 citation statements)

References 19 publications

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“…1). This placebo effect was also found in previous clinical trials for dementia with tacrine [13][14][15][16] and donepezil [11] over 12 weeks, and even after 6 months in a nicergoline study [17]. However, a 12-month study of the effect of piracetam in patients with DAT failed to demonstrate a placebo effect [18].…”

Section: Discussionsupporting

confidence: 77%

Denbufylline in Dementia: A Double-Blind Controlled Study

Treves

Korczyn²

1999

Dement Geriatr Cogn Disord

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The xanthine derivative denbufylline has been evaluated in the treatment of cognitive dysfunction in 110 patients with vascular or mixed dementia (VD) and 226 patients with dementia of the Alzheimer type (DAT). After a run-in period of 4 weeks, during which all patients received placebo, the patients were randomly allocated to denbufylline 25, 50 or 100 mg or to placebo given twice daily for 16 weeks. By the end of the study (completed by 68% of the patients), but also at enrollment, the scores obtained on the Mini-Mental State Examination (MMSE) were higher among those who had received denbufylline than among those who had received placebo, but the differences were not statistically significant; a dose effect of denbufylline was not observed and there was no significant difference in the mean scores of the digit substitution subtest (DSST) of the Wechsler memory test. The responses of patients with VD were similar to those of patients with DAT. When patients were compared in terms of those who received denbufylline versus those who received placebo, improvement in the MMSE scores was observed in 46% of the patients who received placebo and 67% among those who received denbufylline (p < 0.05). An inverse relationship was found between the improvement that occurred during the run-in period and that observed by the end of the study, had the patients received denbufylline or placebo. No major adverse event was ascribed to denbufylline. In conclusion, denbufylline was not deemed efficacious in the treatment of DAT or VD, although patients who received denbufylline tended to improve in terms of cognitive scores, but the effects were not statistically significant. MMSE scores were found to be higher among patients who received denbufylline when these latter were combined as a single group, regardless of their diagnosis or dosage regimen. A placebo effect was observed in about half the patients who completed the study.

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Section: Discussionsupporting

confidence: 77%

Denbufylline in Dementia: A Double-Blind Controlled Study

Treves

Korczyn²

1999

Dement Geriatr Cogn Disord

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“…We suggest alternative goals for therapy, but are aware that few of them are directly assessed by neuropsychological tests, although some are assessed by rating scales. [35][36][37] Level 1, Class C Lecithin 38,39 Level 1, Class C Arecholine 40 Level 1, Class C Nimodipine 41 Level 1, Class C Velnacrine 42 Level 1, Class D Physostigmine [43][44][45] Level 1, Class D Eptastigmine 46 Level 1, Class D Phosphatidylserine 47 Level 1, Class D Memantine 48 Level 1, Class D 4 Aminopyridine (4AP) 49 Level 1, Class D Naloxone 50 Level 1, Class D Linopirdine 51 Level 1, Class D Aniracetam 52 Level 1, Class D Milacemide 53 Level 1, Class D Nicergolin 54 Level 1, Class D Idebenone 55 Level 1, Class D Huperzine-A 56 Level 1, Class D 5'-methyltetrahydrofolic acid 57 Level 1, Class D Desferrioxamine 58 Level 1, Class D Xantinolnicotinate 59 Level 1, Class D Bespirdine 60 Level 1, Class D Cycloserine 61 Level 1, Class D Cyclandelate 62 Level 1, Class D Thyrotropin 63 Level 1, Class D…”

Section: Discussionmentioning

confidence: 99%

The Use of Medications for Cognitive Enhancement

Pryse-Phillips

Sternberg

Rochon

et al. 2001

Can. J. Neurol. Sci.

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Objective:To provide Canadian physicians and allied health care professionals with the evidence they need to help them make treatment decisions in the management of patients with Alzheimer’s disease or other dementias.Options:The full range and quality of diagnostic and therapeutic modalities available to Canadian physicians for the management of dementia.Outcomes:Improvement in the treatment of dementias, leading to reduced suffering, increased functional capacity and decreased economic burden.Evidence and values:The creation of these evidence-based consensus statements involved literature reviews of the subject by the authors; comparison of alternative clinical pathways and description of the methods whereby published data were analyzed; definition of the level of evidence for data in each case; evaluation and revision in a conference setting (involving primary care physicians, neurologists, psychiatrists, geriatricians, psychologists, consumers and other interested parties); insertion of tables showing key variables and data from various studies and tables of data with recommendations; and reassessment by all authors.Benefits, harms, and costs:A rational plan for the therapy of dementias is likely to lead to substantial benefits in both human and economic terms.Recommendations:Treatment decisions should be made taking into account the severity or stage of the disease, the availability of caregivers, the presence of disease affecting other bodily systems and the ability of the subject to pay the cost of the medications. Donepezil is considered to have positive effects upon certain tests of neuropsychological function and may produce some improvement in Alzheimer’s disease of mild to moderate severity as measured by rating scales. Its ability to improve quality of life remains uncertain. No other drug treatments* (apart from symptomatic therapies) are at present approved for the treatment of Alzheimer’s disease.Validation:These recommendations were created by a writing committee, evaluated and revised at a consensus conference and further reviewed and revised by the writing committee prior to publication.

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“…The underlying mechanisms tested can roughly be summarized as anti-inflammatory [12], vasodilatative [13, 14], hemorrheologic [15, 16], neurotrophic/neuroprotective [17, 18, 19], dopaminergic/cholinergic [20, 21], and most recently glutamatergic approaches (memantine, see below). Several drugs have shown mild symptomatic effects in controlled clinical trials, but in many cases the selected population, diagnostic criteria, duration of treatment, or efficacy variables were poorly defined and comparability of the observed effects is difficult.…”

Section: A Refined Methodology For Vad Trials Is Urgently Neededmentioning

confidence: 99%

New Approaches to Clinical Trials in Vascular Dementia: Memantine in Small Vessel Disease

Möbius

Stöffler²

2002

Cerebrovasc Dis

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Although criteria for the diagnosis of vascular dementia (VaD) are established, the diagnostic concept is still controversial and there is no regulatory guidance for clinical drug development. Clinical trials in VaD present a number of pitfalls and challenges and, so far, no compound has received regulatory approval for this indication. The methodological issues of clinical VaD trials are discussed using the development of memantine for this indication as an example. In a pooled analysis of two placebo-controlled trials with the NMDA-antagonist memantine in VaD, the cognitive benefit by memantine treatment was more pronounced for patients with ‘small vessel disease’ than for those with other neuroradiological findings at baseline. In a subgroup of patients with ‘large vessel disease’ or macrolesions, there was less cognitive decline among the placebo patients. It may therefore be helpful to use predefined diagnostic subcategories in clinical studies in this indication. The findings further suggest that stroke or multiple infarctions may not be the primary reason for cognitive decline in VaD patients.

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A Multicenter Randomized Double-Blind Study on the Efficacy and Safety of Nicergoline in Patients with Multi-lnfarct Dementia

Cited by 53 publications

References 19 publications

Denbufylline in Dementia: A Double-Blind Controlled Study

Denbufylline in Dementia: A Double-Blind Controlled Study

The Use of Medications for Cognitive Enhancement

New Approaches to Clinical Trials in Vascular Dementia: Memantine in Small Vessel Disease

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