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Rivastigmine

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841. Estimation of the absolute bioavailability of rivastigmine in patients with mild to moderate dementia of the Alzheimer's type. (Abstract)

Estimation of the absolute bioavailability of rivastigmine in patients with mild to moderate dementia of the Alzheimer's type. To investigate the bioavailability of rivastigmine, an approved therapy for patients with mild to moderate dementia of the Alzheimer's type, at the highest approved single dose of 6 mg.Randomised, two-period crossover, single-centre, non-blinded, inpatient study.Eleven patients (five females and six males) with mean age 69.5 years.The 6 mg oral dose was compared (...) with a 2 mg intravenous dose of rivastigmine infused over a 1-hour period. Plasma concentrations of rivastigmine and its metabolite NAP 226-90 were measured with a gas chromatographic/mass spectrometric method.Following oral administration of a single 6 mg capsule, rivastigmine is rapidly absorbed with an average time to peak plasma concentration of about 1 hour and an average peak concentration of about 25.6 g/L. By a noncompartmental approach, the absolute bioavailability of the 6 mg oral dose

2002 Clinical pharmacokinetics Controlled trial quality: uncertain

842. Brain metabolic and clinical effects of rivastigmine in Alzheimer's disease. Full Text available with Trip Pro

Brain metabolic and clinical effects of rivastigmine in Alzheimer's disease. In-vivo metabolic measures with positron emission tomography using (18)F-fluorodeoxyglucose (FDG-PET) have demonstrated hypometabolism in temporal, frontal, and hippocampal areas during the early stages of Alzheimer's disease (AD). Progression of the dementia in AD involves compromised cholinergic functioning. Cholinesterase inhibitors have demonstrated efficacy in improving cognition and behaviour in AD. In this study (...) , we demonstrate the usefulness of FDG-PET in measuring the progression of untreated AD and its modification by treatment with rivastigmine (Exelon, Novartis Pharmaceuticals, East Hanover, New Jersey, USA), a centrally selective cholinesterase inhibitor of the carbamate type. Patients with mild to moderate probable AD (Mini-Mental Status Exam scores of 10-26, inclusive) were enrolled in a double-blind, placebo controlled comparison of three fixed daily doses of rivastigmine (3, 6, or 9 mg/d

2001 The international journal of neuropsychopharmacology / official scientific journal of the Collegium Internationale Neuropsychopharmacologicum (CINP) Controlled trial quality: uncertain

843. Electrocardiographic effects of rivastigmine. (Abstract)

Electrocardiographic effects of rivastigmine. The electrocardiographic (ECG) effects of rivastigmine treatment were assessed in mild to moderately severe Alzheimer's disease (AD) by analysis of four 26-week, double-blind, multicenter, placebo-controlled, phase III clinical trials. Of an initial 2791 patients, 77% completed treatment. Seventy-one percent required at least one concomitant medication for conditions other than AD, with 34% requiring cardiovascular medications. Safety assessments (...) included ECGs, adverse events, vital signs, and clinical laboratory parameters. Pooled 12-lead ECG data were analyzed by an independent cardiologist blinded to treatment group and clinical information. Heart rate, PR, QRS, and QTc intervals did not differ significantly between treatment and placebo groups. Percentage change from baseline for PR, QRS, and QTc intervals was also no different. In conclusion, rivastigmine appears not to produce adverse effects on cardiac function assessed by ECG.

2002 Journal of clinical pharmacology Controlled trial quality: uncertain

844. Effects of rivastigmine on cognitive function in dementia with lewy bodies: a randomised placebo-controlled international study using the cognitive drug research computerised assessment system. (Abstract)

Effects of rivastigmine on cognitive function in dementia with lewy bodies: a randomised placebo-controlled international study using the cognitive drug research computerised assessment system. This study was designed to assess the effects of rivastigmine (Exelon) on the cognitive functioning of patients suffering from dementia with Lewy bodies. This was a prospective, multi-centre, randomised, double-blind, placebo-controlled exploratory study conducted at sites in the UK, Spain and Italy (...) . The treatment period was 20 weeks with a 3-week posttreatment follow-up. The primary outcome measures were the Cognitive Drug Research (CDR) computerised assessment system and the Neuropsychiatric Inventory. Testing was conducted prior to dosing and then again at weeks 12, 20 and 23. Analysis of the data from the 92 patients who completed the study identified a significant pattern of benefits of rivastigmine over placebo on the CDR system. These benefits were seen on tests of attention, working memory

2002 Dementia and Geriatric Cognitive Disorders Controlled trial quality: uncertain

845. A pilot, randomized, open-label trial assessing safety and pharmakokinetic parameters of co-administration of rivastigmine with risperidone in dementia patients with behavioral disturbances. (Abstract)

A pilot, randomized, open-label trial assessing safety and pharmakokinetic parameters of co-administration of rivastigmine with risperidone in dementia patients with behavioral disturbances. The majority of patients with Alzheimer's disease (AD) or vascular dementia display, in addition to cognitive impairment, various degrees of behavioral disturbances. As the use of cholinesterase inhibitors for the treatment of cognitive impairment in dementia becomes widespread, many of these patients (...) will be treated concomitantly with cholinesterase inhibitors and with anti-psychotic drugs to ameliorate behavioral disturbances. Despite the widespread use of this combination in clinical practice, the safety and tolerability of such combination therapy has not been evaluated in controlled clinical trials. This pilot study examined the effects of addition of risperidone 0.5-2 mg/day to patients on rivastigmine 3-12 mg/day, and vice versa.65 patients suffering from AD, 10 from vascular dementia, and 15 from

2002 International Journal of Geriatric Psychiatry Controlled trial quality: uncertain

846. A multinational, randomised, 12-week, comparative study of donepezil and rivastigmine in patients with mild to moderate Alzheimer's disease. (Abstract)

A multinational, randomised, 12-week, comparative study of donepezil and rivastigmine in patients with mild to moderate Alzheimer's disease. This 12-week, multinational study compared the tolerability and cognitive effects of donepezil (up to 10 mg once daily) and rivastigmine (up to 6 mg twice daily) in 111 patients with mild to moderate Alzheimer's disease. Both medications were administered open label according to recommended dosing regimens from the respective product labelling available (...) during the conduct of the study. More patients in the donepezil group (89.3%) completed the study compared with the rivastigmine group (69.1%; p=0.009), and 10.7% of the donepezil group and 21.8% of the rivastigmine group discontinued due to adverse events (AEs); 87.5% of donepezil-treated patients and 47.3% of rivastigmine-treated patients remained on the maximum approved dose of each drug at the last study visit. Both groups showed comparable improvements on the ADAS-cog administered by raters

2002 International journal of clinical practice Controlled trial quality: uncertain

847. Long-term effects of rivastigmine in moderately severe Alzheimer's disease: does early initiation of therapy offer sustained benefits? (Abstract)

Long-term effects of rivastigmine in moderately severe Alzheimer's disease: does early initiation of therapy offer sustained benefits? Goals of the study included evaluating the long-term efficacy of rivastigmine in Alzheimer's disease (AD) patient categories stratified by baseline dementia severity, and post hoc investigation of particular benefits of early initiation of rivastigmine treatment in moderately severe AD. Both rivastigmine-treated groups (originally randomized to 1-4 or 6-12 mg (...) /day) experienced significantly smaller declines in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) scores from baseline than the projected placebo group after 52 weeks. Patients receiving rivastigmine from Day 1 experienced significantly less decline compared with patients originally receiving placebo and then initiating rivastigmine treatment after a 6-month delay. Furthermore, cognitive benefits were more robust in patients with moderately severe disease compared with previous

2002 Progress in neuro-psychopharmacology & biological psychiatry Controlled trial quality: uncertain

848. Impact of Alzheimer's disease and rivastigmine treatment on activities of daily living over the course of mild to moderately severe disease. (Abstract)

Impact of Alzheimer's disease and rivastigmine treatment on activities of daily living over the course of mild to moderately severe disease. To investigate the relationship between activities of daily living (ADL) impairment and Alzheimer's disease (AD) severity in mild to moderately severe AD patients receiving the cholinesterase (ChE) inhibitor rivastigmine.ADLs were evaluated using the Progressive Deterioration Scale (PDS). Disease severity was assessed with the Global Deterioration Scale (...) (GDS). Patients were participants in one of three double-blind, placebo-controlled trials with rivastigmine.Baseline PDS scores differed significantly (P<.001) by disease severity. At Week 26, PDS declines from baseline for placebo patients were significantly different at all disease stages. Specific ADL affected were disease stage-dependent. Rivastigmine treatment (6-12 mg/day) resulted in total PDS scores being significantly improved compared with placebo at all disease stages, although

2002 Progress in neuro-psychopharmacology & biological psychiatry Controlled trial quality: uncertain

849. Rivastigmine in patients with Alzheimer's disease and concurrent hypertension. (Abstract)

Rivastigmine in patients with Alzheimer's disease and concurrent hypertension. Rivastigmine has demonstrated significant benefits in patients with mild to moderate Alzheimer's disease (AD). We aimed to confirm whether rivastigmine was effective in patients with or without concurrent vascular risk factors (VRF), as previously suggested. We chose to stratify the 725 patients involved in an international dose-ranging study according to the presence of arterial hypertension (a marker of VRF (...) ) at baseline. Efficacy in each subgroup was assessed using the ADAS-cog, a measure of cognitive performance, the Progressive Deterioration Scale (PDS) and the Clinician's Interview-Based Impression of Change (CIBIC) with caregiver input. Patients receiving rivastigmine 6-12 mg/day showed better outcomes on the ADAS-cog than those receiving placebo, in both the hypertensive and non-hypertensive subgroups. Hypertensive patients receiving rivastigmine 6-12 mg/day also showed improvement over those receiving 1

2002 International journal of clinical practice Controlled trial quality: uncertain

850. Analysis of outcome in retrieved dropout patients in a rivastigmine vs placebo, 26-week, Alzheimer disease trial. Full Text available with Trip Pro

Analysis of outcome in retrieved dropout patients in a rivastigmine vs placebo, 26-week, Alzheimer disease trial. Treatment with cholinesterase inhibitors improves cognition in patients with Alzheimer disease (AD). In studies designed with a washout period at the end of the study, after treatment with a cholinesterase inhibitor is discontinued, the cognitive benefits of therapy are no longer apparent following washout. The rivastigmine trials discussed in this article were not designed (...) studies (Novartis US Pivotal [dose-range] Trial, US fixed-dose study, and a Global Pivotal [dose-range] Trial) that compared rivastigmine therapy with placebo. Patients who discontinued study participation (for any reason) (considered to be the RDO population) were encouraged to return for their scheduled week 26 efficacy evaluations. Effects on cognition were assessed using the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog).The results for the Novartis US Pivotal Trials

2003 Archives of neurology Controlled trial quality: predicted high

851. Potentially adaptive functional changes in cognitive processing for patients with multiple sclerosis and their acute modulation by rivastigmine. Full Text available with Trip Pro

Potentially adaptive functional changes in cognitive processing for patients with multiple sclerosis and their acute modulation by rivastigmine. One explanation for the weak relationship between neuropsychological deficits and conventional measures of disease burden in multiple sclerosis is that brain 'plasticity' allows adaptive reorganization of cognitive functions to limit impairment, despite injury. We have tested this hypothesis. Ten patients with multiple sclerosis and 11 healthy controls (...) volume, a measure of disease burden (r = -0.72, P = 0.02). We then tested the effects of acute administration of rivastigmine, a central cholinesterase inhibitor, on patterns of brain activation. In five out of five multiple sclerosis patients there was a relative normalization of the abnormal Stroop-associated brain activation, although no change in the patterns of brain activation was found in any of four healthy controls given the drug and tested in the same way. We suggest that recruitment

2003 Brain Controlled trial quality: uncertain

852. Rivastigmine in subcortical vascular dementia: a randomized, controlled, open 12-month study in 208 patients. (Abstract)

Rivastigmine in subcortical vascular dementia: a randomized, controlled, open 12-month study in 208 patients. Subcortical vascular dementia (VaD) is characterized by executive dysfunction and behavioral problems, reflecting deterioration of the frontal lobe. This study aimed to determine whether rivastigmine, a dual inhibitor of acetylcholinesterase (AChE) and butyryl-cholinesterase (BuChE), has any effects on the typical symptoms of subcortical VaD. Patients receiving rivastigmine showed (...) a slight improvement in executive functions and in behavior. Side effects in both groups were tolerable and there were no study withdrawals. Moreover, there are no drug interactions with other therapies previously and concomitantly assumed. Improvements in domains that characterize subcortical VaD were observed, indicating that rivastigmine may have provided targeted treatment in areas of the brain that are particularly affected in this patient population.

2003 American journal of Alzheimer's disease and other dementias Controlled trial quality: uncertain

853. [Oestro-progestagen treatment combined with rivastigmine in menopausal women suffering from Alzheimer's disease. The results of a 28-weeks controlled study]. (Abstract)

[Oestro-progestagen treatment combined with rivastigmine in menopausal women suffering from Alzheimer's disease. The results of a 28-weeks controlled study]. To compare the efficacy on cognitive function of the combination of hormone replacement therapy with rivastigmine, acetylcholinesterase inhibitor, in menopausal women suffering from mild to moderately severe Alzheimer's disease.This was a randomised double blind study of 117 women suffering from mild to moderately severe Alzheimer-like (...) dementia (MMSE between 10 and 26). The patients were randomly assigned to continuous hormone therapy (n=59) and placebo (n=58), all receiving treatment with rivastigmine. Follow-up was of 28 weeks. ASSESSMENT CRITERIA: ADAS-Cog (Alzheimer's disease assessment scale--cognitive subscale) (primary endpoint); MMSE (mini mental state examination), GDS (global deterioration scale), CGC-Plus (clinical global change-plus), NPI (neuropsychiatric inventory), IADL (instrumental activities of daily living). Data

2003 Presse médicale (Paris, France : 1983) Controlled trial quality: uncertain

854. Potential long-term effects of rivastigmine on disease progression may be linked to drug effects on vascular changes in Alzheimer brains. (Abstract)

Potential long-term effects of rivastigmine on disease progression may be linked to drug effects on vascular changes in Alzheimer brains. Alzheimer's disease patients with hypertension or other vascular risk factors have been shown to receive greater symptomatic benefits than patients with strictly Alzheimer's disease following short-term treatment with rivastigmine, an inhibitor of acetylcholinesterase and butyrylcholinesterase. We evaluated the long-term efficacy of rivastigmine (...) in Alzheimer's disease patients with or without hypertension. Subjects in a 26-week placebo-controlled trial of rivastigmine entered an open-label extension study for 104 weeks. Efficacy measures included the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Progressive Deterioration Scale (PDS) and Global Deterioration Scale (GDS). Subjects were stratified by the presence or absence of hypertension at baseline. At 104 weeks, there was a trend for hypertensive patients from the original

2003 International journal of clinical practice Controlled trial quality: uncertain

855. Sustained cholinesterase inhibition in AD patients receiving rivastigmine for 12 months. (Abstract)

Sustained cholinesterase inhibition in AD patients receiving rivastigmine for 12 months. To study the long-term dual inhibitory effects of rivastigmine on acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) in patients with AD.Eleven patients with mild AD received rivastigmine for 12 months. Cholinesterase (ChE) activities in the CSF and plasma were assessed colorimetrically. Immunoblot analysis was used to evaluate AChE isoforms. Neuropsychiatric tests were performed throughout (...) the study.At 12 months, the mean dose of rivastigmine was 8.6 mg/d and specific activities of ChE in the CSF were lower than baseline values (by 36% for AChE and 45% for BuChE), correlating with parallel reductions in the plasma (27% for AChE and 33% for BuChE). The reduction of specific activities in the CSF, but not in the plasma, appeared to be dependent on the dose and duration of treatment. Scores of some of the neuropsychological tests associated with memory and attention were correlated with both

2002 Neurology

856. Alterations in brain activation during cholinergic enhancement with rivastigmine in Alzheimer's disease. Full Text available with Trip Pro

Alterations in brain activation during cholinergic enhancement with rivastigmine in Alzheimer's disease. Rivastigmine enhances cholinergic activity and has been shown in clinical trials to decrease the rate of deterioration in Alzheimer's disease. It remains unclear where in the brain it exerts its effect. Functional magnetic resonance imaging (fMRI) can be used to measure changes in brain function and relate these to cognition.To use fMRI to study brain activation with rivastigmine (...) treatment.The effect on brain activation of a single dose of rivastigmine was tested in seven patients with mild Alzheimer's disease using fMRI during face encoding, and in five patients during a parametric working memory task.During face encoding, rivastigmine increased bilateral activation in the fusiform gyrus. Brain activation was also enhanced in the prefrontal cortex in a simple working memory task. When working memory load was further increased, not only was increased activation seen, but in certain

2002 Neurosurgery and Psychiatry

857. Pharmacokinetics and bioavailability of the novel rivastigmine transdermal patch versus rivastigmine oral solution in healthy elderly subjects. (Abstract)

Pharmacokinetics and bioavailability of the novel rivastigmine transdermal patch versus rivastigmine oral solution in healthy elderly subjects. 18199897 2008 05 19 2015 11 19 0091-2700 48 2 2008 Feb Journal of clinical pharmacology J Clin Pharmacol Pharmacokinetics and bioavailability of the novel rivastigmine transdermal patch versus rivastigmine oral solution in healthy elderly subjects. 246-52 10.1177/0091270007312154 Lefèvre Gilbert G Novartis Pharma AG, Exploratory Development, WSJ (...) -210.4.25, CH-4002 Basel, Switzerland. gilbert.lefevre@novartis.com Pommier Françoise F Sedek Greg G Allison Mark M Huang Hsun-Lun Aaron HL Kiese Beate B Ho Yu-Yun YY Appel-Dingemanse Silke S eng Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't England J Clin Pharmacol 0366372 0091-2700 0 3-(1-dimethylaminoethyl)phenol 0 Benzylamines 0 Cholinesterase Inhibitors 0 Phenethylamines 0 Phenols 0 Phenylcarbamates 0 Solutions PKI06M3IW0 Rivastigmine IM Administration, Cutaneous

2008 Journal of clinical pharmacology Controlled trial quality: uncertain

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