The effects of transdermal rotigotine on non-motor symptoms of Parkinson's disease: a multicentre, observational, retrospective, post-marketing study.

AIM: This study evaluated the effect of ≥6 months of transdermal rotigotine on non-motor and motor symptoms of patients with advanced Parkinson's disease. MATERIALS AND METHODS: The study was conducted in Spain between September 2011 and December 2012 (ClinicalTrials.gov: NCT01504529). The primary efficacy variable was the change from baseline in non-motor symptoms, as assessed by changes in Parkinson's Disease Non-Motor Symptoms Questionnaire total scores at 6 months. Secondary endpoints included the assessment of motor symptoms by Unified Parkinson's Disease Rating Scale III scores. RESULTS: Data from 378 patients (mean age: 70.2 years; 56.9% male) with Parkinson's disease receiving rotigotine from were collected. Mean disease duration was 6.1 years, and mean rotigotine treatment duration was 45.6 months. Rotigotine reduced non-motor symptoms by 14.6% (mean change from baseline in Parkinson's Disease Non-Motor Symptoms Questionnaire: -1.5 ± 3.4; p < 0.0001). The majority of patients (58.2%) had improved non-motor symptoms at 6 months. Comparing the baseline versus study end, fewer patients experienced events in the urinary (78.6% vs. 73.3%; p = 0.0066), sleep (82.8% vs. 72.8%; p < 0.0001) and mood/cognition (77.3% vs. 66.4%; p < 0.0001) domains of the Parkinson's Disease Non-Motor Symptoms Questionnaire. Mean motor symptoms were reduced from baseline by 8.0% (mean change from baseline in Unified Parkinson's Disease Rating Scale III: -2.6 ± 8.0; p < 0.0001). CONCLUSIONS: In clinical practice in Spain, rotigotine may be an effective treatment to reduce the non-motor and motor symptoms in patients with advanced Parkinson's disease.

Synergistic Increase of Serum BDNF in Alzheimer Patients Treated with Cerebrolysin and Donepezil: Association with Cognitive Improvement in ApoE4 Cases.

BACKGROUND: Low circulating brain derived neurotrophic factor may promote cognitive deterioration, but the effects of neurotrophic and combination drug therapies on serum brain derived neurotrophic factor were not previously investigated in Alzheimer's disease. METHODS: We evaluated the effects of Cerebrolysin, donepezil, and the combined therapy on brain derived neurotrophic factor serum levels at week 16 (end of Cerebrolysin treatment) and week 28 (endpoint) in mild-to-moderate Alzheimer's disease patients. RESULTS: Cerebrolysin, but not donepezil, increased serum brain derived neurotrophic factor at week 16, while the combination therapy enhanced it at both week 16 and study endpoint. Brain derived neurotrophic factor responses were significantly higher in the combination therapy group than in donepezil and Cerebrolysin groups at week 16 and week 28, respectively. Brain derived neurotrophic factor increases were greater in apolipoprotein E epsilon-4 allele carriers, and higher brain derived neurotrophic factor levels were associated with better cognitive improvements in apolipoprotein E epsilon-4 allele patients treated with Cerebrolysin and the combined therapy. CONCLUSION: Our results indicate a synergistic action of Cerebrolysin and donepezil to increase serum brain derived neurotrophic factor and delaying cognitive decline, particularly in Alzheimer's disease cases with apolipoprotein E epsilon-4 allele.

Efficacy of levodopa/carbidopa/entacapone versus levodopa/carbidopa in patients with early Parkinson's disease experiencing mild wearing-off: a randomised, double-blind trial.

To compare the efficacy and safety of levodopa/carbidopa/entacapone (LCE) with levodopa/carbidopa (LC) on Parkinson's disease (PD) patients with mild, or only minimally disabling motor complications. A prospective 3-month, multicentre, parallel-group, double-blind, and randomised phase IV study was performed. The primary endpoint was to assess the efficacy of LCE compared to LC on ADLs using the UPDRS part II. Secondary endpoints were assessed by the UPDRS (I, III and IV) scores, QUICK and PDQ-39 questionnaires, and patient and investigator clinical global impression (CGI). Ninety-five patients were randomly assigned to treatment with LCE (100/25/200 or 150/37.5/200 mg tablets, n = 46) or LC (100/25 mg tablets, n = 49), at the same levodopa dose that were administered before randomization. Treatment with LCE resulted in significantly greater improvement in UPDRS part II (ADLs) scores compared to treatment with LC (adjusted mean difference between groups of -1.5 points) (p = 0.0288). Amelioration was also observed in UPDRS part III scores (p = 0.010), and CGI (patient and investigator) scores (p = 0.015, and p = 0.028, respectively). LCE and LC were generally well tolerated with 78 % of subjects completing the study. Most AEs (50 % in LCE and 71.4 % in LC) were classified as mild. No serious AEs were related to the treatment. Treatment with LCE results in improved efficacy compared to LC in PD patients with mild, or minimally disabling motor fluctuations, maintaining a good safety and tolerability profile.

Variability in the diagnosis and management of patients with Alzheimer's disease and cerebrovascular disease: results from the GALATEA multicentre, observational study.

BACKGROUND AND OBJECTIVES: There is frequently a degree of variability among different types of dementia specialists in clinical practice in both the clinical diagnosis and the management of patients with Alzheimer's disease and cerebrovascular disease (CVD). This variability may have an adverse effect on the use of medical resources as well as on patients' well-being. The main objective of this study was to describe the current diagnosis and management of patients with Alzheimer's disease and CVD in Spain. Other objectives were to determine whether there were significant differences in the diagnosis and management of these patients depending on physician characteristics and/or patient profile. METHODS: This was an epidemiological, cross-sectional, multicentre study in which 107 physicians participated and recruited patients with Alzheimer's disease and CVD. During a 1-month period, physicians collected data on diagnosis, treatment, follow-up, adverse events and other characteristics of these patients. This study was performed under naturalistic conditions, and no restrictions were imposed on the physicians. RESULTS: Physicians were mainly neurologists (76%), geriatricians (14%) and psychiatrists (8%) with a median age of 42 years. A total of 720 patients with a diagnosis of Alzheimer's disease and CVD were recruited. The median age of the patients was 78 years. Almost all patients were diagnosed by neuroimaging (98%) together with medical history (87%). The existence of a previous stroke coincident with cognitive deterioration was used as a diagnostic method in only 27% of patients. Among non-pharmacological treatment measures, diet was the most frequently recommended (61%), followed by cognitive stimulation (50%) and physical exercise (44%). The most commonly used pharmacological treatments were galantamine (59%), donepezil (14%) and rivastigmine (11%). The incidence of adverse events was low (3%), and all were considered non-severe. There were no significant correlations between physician age or physician years of practice and the diagnostic method used. The diagnostic method most frequently used by psychiatrists (100%) and geriatricians (97%) was medical history whereas this method was not used as much by neurologists (85%) [p = 0.0150]. Neuroimaging methods were more frequently used by neurologists (99%) and geriatricians (96%) compared with psychiatrists (84%) [p < 0.0001]. Patients with attention disorders had a higher frequency of follow-up visits (p = 0.0145) and were treated less frequently with donepezil (p = 0.0118). CONCLUSIONS: Several possible areas of improvement in the management of patients with Alzheimer's disease and CVD were identified. These included better control of cardiovascular risk factors, such as hypertension and hyperlipidaemia, which have a high prevalence in this population, as has been shown in the present study. These potentially modifiable risk factors may assist in the prevention of Alzheimer's disease. Also identified was the need to emphasize the role of general practitioners in decreasing the time to diagnosis of Alzheimer's disease. Development of well designed clinical practice guidelines may help physicians decide on the most appropriate ways of diagnosing and managing patients with Alzheimer's disease and CVD and reduce practice variations between different medical specialities.