[The influence of nooclerin on the structure of sleep disturbances in children with tension headaches]. / Vliianie nooklerina na strukturu narushenii sna u detei s golovnymi boliami napriazheniia.

AIM: To study the effects of nooclerin (deanol aceglumate) on the structure of sleep disturbances in children with tension-type headache (TTH). MATERIAL AND METHODS: A blind randomized placebo-controlled study of the efficacy of nooclerin (deanol aceglumate), prescribed for 2 months to prevent TTH, was carried out. The study included 60 patients (30 boys and 30 girls), aged 9-16 years, with TTH. Patients were randomized into the nooclerin group (n=30) and the placebo group (n=30). Sleep disturbances were assessed before and after treatment with the Sleep Disturbance Scale for Children (SDSC). RESULTS: There was a significant positive dynamics (reduced total score on SDSC (p<0.001) and a significant decrease in the scores on scales 'Disorders of initiating and maintaining sleep', 'Disorders of excessive somnolence' (p<0.001), 'Sleep wake transition disorders' (p<0.01)) in the nooclerin group. No significant positive changes were detected in the placebo group. CONCLUSION: An anxiolytic action of nooclerin was confirmed. Further studies of the drug in child neurology and psychiatry using larger groups of patients are needed.

[Alcohol withdrawal syndrome dynamics during treatment with nooclerin (deanoli aceglumas)]. / Dinamika simptomov sindroma otmeny alkogolia v protsesse lecheniia nooklerinom (deanola atseglumat).

AIM: To study the efficacy of nooclerin (deanoli aceglumas) in alcohol withdrawal syndrome assessed by clinical and biochemical characteristics. MATERIAL AND METHODS: A multicenter, open, randomized, comparative study of nooclerin in the complex treatment of alcohol withdrawal syndrome included 90 patients. The patients were randomized into nooclerin group (n=55) and control group (n=35). RESULTS AND CONCLUSION: Nooclerin reduced alcohol withdrawal symptoms more significantly throughout the whole study period. There were significant between-group differences on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and the Multidimensional Fatigue Inventory (МFI-20). However, patients exhibited no excessive activity. No adverse side-effects were observed.

[Syndrome of autonomic dysfunction in children and adolescents]. / Sindrom vegetativnoi disfunktsii u detei i podrostkov.

AIM: To study clinical and pathophysiological symptoms of autonomic dysfunction syndrome in children and adolescents and assess the efficacy of its treatment with nooclerin. MATERIAL AND METHODS: Fifty-three patients, aged from 10 to 15 years, with autonomic dysfunction syndrome were examined. All patients underwent neurological examination, assessment with the A.M. Vein's questionnaire of autonomic disorders, the 10 point Visual Analogous scale for headache and fatigue, the Spielberger-Khanin scale for anxiety, Kerdo index, Hildebrandt's coefficient, electrocardiography with clinoorthostatic test, electroencephalography, and TOVA psychophysiological test. RESULTS AND CONCLUSION: The signs of the asthenic-autonomic syndrome were characteristic of the clinical picture of disease. EEG results demonstrated the deficit of activation effects, predominance of synchronized effects of thalamic structures which led to the insufficient activation of cortical structures. These data support the high efficacy of nooclerin.

[Nooklerin (deanoli aceglumas) in the treatment of astenic and cognitive disorders in patients with borderline psychopatological conditions]. / Opyt primeneniia nooklerina (deanola atseglumat) pri terapii kognitivnykh i astenicheskikh rasstroistv u bol'nykh s pogranichnoi psikhicheskoi patologiei.

BACKGROUND: This work is devoted to the combined therapy of asthenic syndrome in psychiatric patients due to the importanmce of studies of clinical signs of asthenic disorders and their comorbidity with psychiatric and somatic diseases. AIM: To evaluate the efficacy and safety of deanoli aceglumas (nooklerin) in treatment of asthenic and cognitive disorders in patients with borderline psychopathological conditions. MATERIAL AND METHODS: Sixty patients were enrolled in the study (30 patients of the main group and 30 patients of the control group). All patients received psychopharmacological treatment. Nooklerin was administered as add-on in the daily dose of 1000 mg in the main group. Psychopathological and psychometric examinations were conducted. The duration of treatment with nooklerin was 30 days. RESULTS: There was a significant reduction of asthenic and cognitive disorders in the main group compared to the controls. The good tolerability of nooklerin in the absence of a negative effect on the main disease was shown. CONCLUSION: The possibility of using deanoli aceglumas (nooklerin) as a drug of choice in combined treatment of asthenic and cognitive disorders in patients with borderline psychopathological conditions is confirmed.

Assessment of a Comprehensive Anti-Aging Neck Cream.

INTRODUCTION: With many effective anti-aging solutions for the face, consumer focus is now turning to other parts of the body including the delicate skin on the neck. This study investigates the effect of a new neck cream on the appearance of texture, fine lines and wrinkles, laxity, and hydration. METHODS: 85 adult females ages 35-65 with Fitzpatrick skin types I through IV applied the test neck cream twice daily for a 3-month study period. Screening was conducted at Baseline, 2, 30, 60, and 90 days via a virtual trial. Subjects rated satisfaction in each of 4 anti-aging categories including hydration, texture, appearance of wrinkles, and appearance of laxity as well as three product attributes including application, feel, and smell. RESULTS: Improvement was statistically significant for all measured categories (hydration, texture, appearance of wrinkles, and appearance of laxity) with 94% of study subjects noting improvement in one or more of the measured categories. Further, the quantity of "Satisfied" and "Highly Satisfied" assessments increased 8-fold from baseline with a 94x increase in the quantity of "Highly Satisfied" assessments. DISCUSSION: The results demonstrate the product's rapid and continuing ability to improve the self-perceived signs of aging in the neck area including improvement in skin texture on the neck and a reduction in the appearance of wrinkles and laxity along the jawline. Future studies are recommended to determine the primary action mechanisms and to assess the degree of improvement by blinded physician assessment.

Effect of six months of treatment with V0191 in patients with suspected prodromal Alzheimer's disease.

New criteria related to prodromal Alzheimer's disease (AD) have been proposed to overcome the issue of heterogeneity of patients with mild cognitive impairment (MCI) and to better define patients in early stage AD. Only few therapeutic trials, if any, have been reported using this newly defined population. The objective of this study was to assess the clinical efficacy and safety of a novel pro-cholinergic drug (V0191) in patients with prodromal AD. Two hundred forty two (242) patients with a diagnosis of prodromal AD were randomized in an approximately 1 : 1 ratio to receive either 1500 mg V0191 or matching placebo once daily for 24 weeks. Changes in global cognitive functioning were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog; responder rate as primary efficacy measure). Standardized measures of memory, executive function, attention, functional capacity, and apathy were also obtained. Despite some interesting trends at week 12 and conversion rates favoring V0191, no statistically significant differences in cognitive function between V0191 and placebo were noted. In addition to the absence of drug efficacy on this population, several design features may have hindered this study, including insufficient powering to assess changes in cognition over time, a relatively short duration of treatment, and the lack of validated clinical trial measures designed to assess the prodromal AD population. Lessons learned in AD study design optimization, including those presented in this paper, could be valuable for further investigation with pro-cholinergic drugs such as V0191.

Synthesis and anticonvulsant evaluation of dimethylethanolamine analogues of valproic acid and its tetramethylcyclopropyl analogue.

BACKGROUND: Valproic acid (VPA) is a major antiepileptic drug (AED) that is less potent than other AEDs. 2,2,3,3-Tetramethylcyclopropanecarboxylic acid (TMCA) is an inactive cyclopropyl analogue of VPA that serves as a starting material for the synthesis of CNS-active compounds. METHODS: New conjugation products between N,N'-dimethylethanolamine to VPA and TMCA to form N,N-dimethylethanolamine valproate (DEVA) and N,N-dimethylethanolamine 2,2,3,3-tetramethylcyclopropionate were synthesized and their anticonvulsant activity was assessed in the maximal electroshock seizure (MES) and subcutaneous metrazol (scMet) seizure tests and the hippocampal kindling model in mice and/or rats. An amide analogue of DEVA (DEVAMIDE) was also synthesized and evaluated. The pharmacokinetics of DEVA and DEVAMIDE was comparatively evaluated in rats. RESULTS: In rats DEVA acted as a prodrug of VPA and had ED(50) values of 73 mg/kg and 158 mg/kg in the MES and the hippocampal kindling models, respectively. At these two anticonvulsant models DEVA was seven-times more potent than VPA. DEVAMIDE was active in the MES test at doses of 100 mg/kg (mice) and its rat-MES-ED(50)=38.6 mg/kg however, its protective index (PI=TD(50)/ED(50)) was twice lower than DEVA's PI. The TMCA analogues were inactive at the mice MES and scMet models. DEVA underwent rapid metabolic hydrolysis to VPA and consequently, in its pharmacokinetic analysis only VPA plasma levels were monitored. In contrast, DEVAMIDE was stable in whole blood. CONCLUSION: DEVA acts in rats as a prodrug of VPA yet shows a more potent anticonvulsant activity than VPA. DEVAMIDE acted as the drug on its own and was more potent than DEVA at the rat-MES test.

Randomised, placebo-controlled, double-blind, split-face study on the clinical efficacy of Tricutan on skin firmness.

Tricutan is a combination product of herbal extracts traditionally used for treatment of skin conditions, together with dimethylaminoethanol. The effectiveness of Tricutan in improving skin firmness and elasticity in photoaged facial skin was examined in a randomised, placebo-controlled, double-blind, split-face study in 28 women, 34-67 years old. Treatment with Tricutan and placebo was given for 4 weeks. Skin firmness and elasticity was evaluated using the speed of propagation of ultrasound shear waves in the skin as end point (Reviscometer RVM 600). The study was completed by 25 women. The Tricutan treatment resulted in a significantly reduced propagation speed indicating increased firmness. There was no immediate effect by Tricutan application on propagation speed. At self evaluation the women evaluated the treatment effect of Tricutan to be significantly better than the treatment effect of placebo. The clinical evaluation also showed Tricutan to give a significantly better treatment result than placebo. Tolerance to Tricutan was generally good. However, three women did not complete the study because of mild irritative contact dermatitis. The results show that Tricutan can increase skin firmness both objectively and subjectively. Further studies are warranted, especially to investigate if Tricutan can delay the need for surgical face-lift procedures.

[Effects of nootropic agents on visual functions and lacrimal antioxidative activity in patients with primary open-angle glaucoma].

The paper presents the results of an investigation of the effect of the nootropic agents pantogam and nooclerine on visual functions in patients with primary open-angle glaucoma. These agents have been found to have a beneficial effect on the functional activity of the retina and optic nerve, light sensitivity, hemo- and hydrodynamics of the eye.

Efficacy of dimethylaminoethanol (DMAE) containing vitamin-mineral drug combination on EEG patterns in the presence of different emotional states.

The psychophysiological model of provoking different emotional states by watching film excerpts with various emotional contents was used to characterize drug action in 80 subjects (male/female=50%) with threshold emotional disturbance within a randomized, group-parallel, double-blind, placebo-controlled study. Analyzing the brain's electrical reaction during presentation of 5 videoclips of 7 min duration followed by 3 minutes pause revealed a content specific representation of topographical frequency changes. This procedure was repeated after 6 and 12 weeks of daily intake of a vitamin-mineral drug combination containing dimethylaminoethanol (DMAE) (Vitagerin Geistlich N) or placebo. Subjects taking the active drug for 3 months developed significant less theta and alpha1 power in sensomotoric areas of the cortex. The grade of change and statistical significance was dependend on the content of the excerpt, but the pattern of changes in general remained the same. Since decreases in theta and alpha1 electrical power have been associated with increased vigilance and attention, subjects taking the drug combination obviously were more active and felt better. - Analysis of the emotional change in mood profile as induced by the TV session was achieved by completing two different quenstionaires (POMS and Bf-S). Both scores revealed a better mood for the active drug group thus corroborating the results from EEG analysis. Therefore the vitamine-mineral drug combination containing DMAE can be interpreted to induce a psychophysiological state of better feeling of wellbeing on both levels of analysis mood and electrical pattern of brain activity in subjects suffering from borderline emotional disturbance.

Source density analysis of functional topographical EEG: monitoring of cognitive drug action.

Electrical changes of the brain induced by mental work in the presence or absence of a drug formulation containing dimethylaminoethanolorotrate (DMAE), vitamins and minerals were analysed. Sixty elderly volunteers (30 females and 30 males; aged 40 - 65) who lacked concentration and efficiency during mental exercise according to their own opinions participated in a double-blind, placebo-controlled study. The EEG recordings were carried out before and after 12 weeks medication and were analysed according to the electrical charges at the scalp surface (Laplacian estimate) followed by Fast Fourier Transformation to obtain quantitative data. Whereas no change of electrical charge could be observed after 12 weeks of treatment in the placebo group, the verum group taking 1 capsule per day of an established drug containing a biogenic amine-vitamin combination revealed decreases in theta power during rest and increases in absolute theta power induced by mental demand within the area known to change its electrical activity during mental exercise. In the light of the current hypothesis that high theta resting power and low increases at frontotemporal brain areas during mental work indicate mental impairment, treatment with the drug under investigation was seen to successfully reverse these changes. This drug effect was localized in the frontotemporal cortex in a statistically significant manner during both the memory and the symbol recognition tests. The observed effect is fully consistent with a previous study using Fourier transformed data from conventional EEG voltage recordings. It can be concluded that an analysis of EEG data by means of the charge mode provides an excellent tool to quantify drug effects especially in cognitive research. A second perspective arises from the fact that it should be possible to recognize mental impairments at a very early stage by using this method, thus providing the possibility of an early treatment.

Use of DMAE (2-dimethylaminoethanol) in the induction of lucid dreams.

A food supplement, namely DMAE, that facilitates the induction of lucid dreams is discussed. Included is a brief consideration of the therapeutic potential of such dreams.

Controversies in the treatment of autistic children: vitamin and drug therapy.

A survey of approximately 4,000 questionnaires completed by parents of autistic children provided ratings on a variety of treatments and interventions. Among the biomedical treatments, the use of high-dosage vitamin B6 and magnesium (n = 318) received the highest ratings, with 8.5 parents reporting behavioral improvement to every one reporting behavioral worsening. Deanol (n = 121) was next most highly rated, with 1.8 parents reporting improvement to each one reporting worsening. Fenfluramine (n = 104) was third, with a ratio of 1.5:1. Thioridazine hydrochloride (Mellaril), by far the most often used drug on the list (n = 724), was fourth with a helped-worsened ratio of 1.4:1. The research literature on the use of vitamin B6-magnesium is briefly reviewed, and mention is made of recent findings regarding high-dosage folic acid in autism and biotin in Rett syndrome.