Proof of Therapeutical Effectiveness of Nootropic and Vasoactive Drugs : Advances in Clinical and Experimental Nicergoline Research

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature. ## Problems of the Therapeutic Evaluation of Vaso-active and Nootropic Substances in Cerebral and Peripheral Arterial Obstructive Disease Although vasodilators and nootropic agents have long been used in the management of cerebrovascular diseases, it remains extraordinarily difficult at the present time to assess their values factually, i.e. objectively and unemotionally. The principal reasons for this are as follows: 1. The efficacy or inefficacy of vasodilator or nootropic agents is often assessed in short-term tests on the basis of the cerebral blood flow. However, for methodological reasons, such results provide data merely on the mode of action and not the therapeutic response, 2. Haemodynamic investigations, even if they include longitudinal measurements and are performed under controlled study conditions, cannot detect intellectual or affective disorders which are often the primary symptoms as well as the therapeutic targets in cerebrovascular insufficiency, 3. The therapeutic efficacy ofnootropic agents and vasodilators is sometimes postulated only on the basis of animal studies or in-vitro experiments but such a construct is not usually justified, 4. Many therapeutic trials in the last twenty years were not carried out as controlled -that is randomised and doubleblind -studies so that placebo effects and spontaneous improvements could not be excluded. Furthermore, in the majority of studies, the samples were not homogeneous and not broken down according to age, sex, aetiology and severity of the disease; the trial objectives were frequently not defined, there were often no indications of concomitant disorders and their treatments and the trial parameters were often not standardised and consist chiefly of subjective criteria which could not be quantified, 5. Too few controlled studies are as yet available and the validity of study parameters is always being called into question when a clinical, or therapeutic, response is demonstrated for vaso-active or nootropic agents. Nevertheless, an objective analysis of the clinical experience and the first controlled therapeutic trials leaves no doubt that at least some vasodilators or nootropic agents induce clinically relevant improvements in cerebrovascular disorders which represent statistically significant differences from placebos. Therapeutic efficacy should, however, only be assumed if it is unequivocally documented in controlled therapeutic studies against placebo or by a mental training treatment. It will therefore have to be an objective of the next few years. 1. To increase the number of stringently controlled studies with primarily clinical target parameters in order to demonstrate the efficacy or inefficacy of this group of drugs, and VI Problems of the Therapeutic Evaluation 2. To learn by stratification, under which conditions an individual patient is likely to respond with a therapeutically relevant improvement. From these aspects, the objectives to be attempted with the following contributions and discussions are: 1. To discuss the principles, possibilities and limitations of methods to demonstrate the therapeutic efficacy of vasoactive or nootropic agents in cerebrovascular disease, 2. To discuss the value of results from animal experiments and haemorrheological investigations for the treatment of impaired cerebral function of vascular origin, and 3. To outline the practicabiltty of the demonstration of therapeutic efficacy and the therapeutic relevance of vasodilators and nootropic drugs in the cerebral field with the aid of nicergoline\*. Front Matter....Pages I-XI Front Matter....Pages 1-1 Principles of Controlled Clinical Studies in Psychogeriatrics....Pages 3-15 Prognosis of Cerebrovascular Disease....Pages 17-22 Front Matter....Pages 23-23 Promoting Vigilance in Older People: Comparative Pharmaco-EEG and Psychometric Studies with Nicergoline by Oral and Intramuscular Administration....Pages 25-44 Correlation Between Computerized EEG and Clinical Findings in Patients with Senile Dementia....Pages 45-50 A Placebo-Controlled Study with Nicergoline in Patients with Organic Brain Syndrome, Suffering from Cochlear and Vestibular Disturbances....Pages 51-58 Front Matter....Pages 59-59 Neurotransmitter Alterations in the Aging Brain....Pages 61-101 Neurochemical Effects of Ergoline Derivatives....Pages 103-110 Pharmacological Intervention on Some Enzyme Activities of Various Brain Areas During Hypoxia and Post-Hypoxic Recovery....Pages 111-118 The Effects of Nicergoline and Other Vaso-Active Substances on Molecular Biological Processes in the Brain and Their Effects on the Learning Abilities of Rats....Pages 119-130 Front Matter....Pages 131-131 Salutary Actions of Nicergoline During Experimental Coronary Artery Occlusion and Reperfusion....Pages 133-147 Front Matter....Pages 149-149 A General Introduction to Haemorrheology and its Clinical Importance....Pages 151-158 Effects of a Single I.V. Dose of Nicergoline on Haemorrheological and Haemodynamic Parameters in Peripheral Vascular Disease. A Double-Blind, Cross-over Study....Pages 159-168 The Effects of Nicergoline on the Filtrability of Hyperosmolar Blood....Pages 169-172 Influence of Nicergoline on Platelet Aggregation and Erythrocyte Filterability....Pages 173-184 Front Matter....Pages 185-185 Nicergoline Injectable in the Treatment of Cochlear Emergencies....Pages 187-194 Long-Term Study with Nicergoline in Ophthalmological Practice....Pages 195-202 Front Matter....Pages 203-203 Transitory Ischaemic Attacks and Their Treatment with Nicergoline....Pages 205-214 Methodological Approach to the Clinical Evaluation of Nootropic Drugs....Pages 215-222 Front Matter....Pages 223-223 Haemodynamic and Metabolic Effects of Nicergoline in Healthy and Arteritic Patients at Rest or During Exercise....Pages 225-232 Front Matter....Pages 233-233 Nicergoline and Impaired Brain Function. Results of a One-Year Clinical Trial....Pages 235-253 Back Matter....Pages 255-258 Edited By H. Heidrich ; [translator, Dora Wirth Ltd.]. Translation Of: Therapeutische Wirksamkeitsnachweise Bei Nootropen Und Vasoaktiven Substanzen. Includes Bibliographies And Index.