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Article ; Online: Guidelines for the management of cognitive and behavioral problems in dementia.

Sadowsky, Carl H / Galvin, James E

Journal of the American Board of Family Medicine : JABFM

2012 Volume 25, Issue 3, Page(s) 350–366

Abstract: Family physicians play a crucial role in the management and ongoing care of patients with Alzheimer disease (AD). This article reviews the effects of nonpharmacologic and pharmacologic interventions on the functional abilities and behavior of patients ... ...

Abstract	Family physicians play a crucial role in the management and ongoing care of patients with Alzheimer disease (AD). This article reviews the effects of nonpharmacologic and pharmacologic interventions on the functional abilities and behavior of patients with dementia and how these can be implemented into clinical practice. Nonpharmacologic interventions are recommended as the initial strategy for managing problematic behaviors. Strategies for improving behavior include ensuring that the patient's environment is safe, calm, and predictable; removing environmental stressors; and identifying and avoiding situations that agitate or frighten the patient. Simple interventions include redirecting and refocusing the patient, increasing social interaction, establishing regular sleep habits, eliminating sources of conflict and frustration, and establishing rewards for successes. The effectiveness of long-term behavioral management is largely dependent on the caregiver; as such, it is important to assess the role and needs of the caregiver. Because currently available therapies cannot reverse the pathologic processes of AD, the primary objective of pharmacotherapy is to preserve cognitive and functional ability, minimize behavioral disturbances, and slow disease progression. Cholinesterase inhibitors represent first-line therapy for patients with mild to moderate AD, whereas a glutamate N-methyl D-aspartate antagonist is used in the treatment of moderate to severe AD. Looking forward, there are a number of therapies in development aimed at modifying the disease course; these include amyloid-lowering drugs, τ-based and neuroprotective approaches, acetylcholine agonists, and mitochondrial inhibitors.
MeSH term(s)	Algorithms ; Alzheimer Disease/complications ; Alzheimer Disease/pathology ; Alzheimer Disease/psychology ; Behavior Therapy ; Cholinesterase Inhibitors/therapeutic use ; Cognition/drug effects ; Cognition Disorders/drug therapy ; Cognition Disorders/etiology ; Cognition Disorders/pathology ; Cognitive Therapy ; Humans ; Mental Disorders/drug therapy ; Mental Disorders/etiology ; Mental Disorders/psychology ; Mood Disorders/drug therapy ; Mood Disorders/etiology ; Practice Guidelines as Topic ; Psychometrics ; Psychomotor Agitation/drug therapy ; Psychomotor Agitation/etiology ; Receptors, N-Methyl-D-Aspartate/antagonists & inhibitors ; Severity of Illness Index
Chemical Substances	Cholinesterase Inhibitors ; Receptors, N-Methyl-D-Aspartate
Language	English
Publishing date	2012-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2239939-2
ISSN	1558-7118 ; 1557-2625
ISSN (online)	1558-7118
ISSN	1557-2625
DOI	10.3122/jabfm.2012.03.100183
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Article ; Online: Practical guidelines for the recognition and diagnosis of dementia.

Galvin, James E / Sadowsky, Carl H

Journal of the American Board of Family Medicine : JABFM

2012 Volume 25, Issue 3, Page(s) 367–382

Abstract: To date, user-friendly, practical guidelines for dementia have not been available for busy family physicians. However, the growing number of patients with dementia means that primary care physicians will have an increasingly important role in the ... ...

Abstract	To date, user-friendly, practical guidelines for dementia have not been available for busy family physicians. However, the growing number of patients with dementia means that primary care physicians will have an increasingly important role in the diagnosis and subsequent management of dementia. This article provides practical guidance for the recognition and diagnosis of dementia and is aimed at family physicians, who are usually the first clinicians to whom patients present with dementia symptoms. Because Alzheimer disease (AD) is the most common form of dementia, this condition is the main focus of this article. We review the pathophysiology of AD and discuss recommended diagnostic protocols and the importance of early diagnosis. An AD diagnostic algorithm is provided, with clearly defined steps for screening and diagnosing AD and assessing daily functioning, behavioral symptoms, and caregiver status.
MeSH term(s)	Algorithms ; Dementia/diagnosis ; Dementia/pathology ; Dementia/psychology ; Diagnosis, Differential ; Humans ; Mass Screening ; Primary Health Care ; Psychometrics ; Time Factors ; United States
Language	English
Publishing date	2012-05
Publishing country	United States
Document type	Journal Article ; Practice Guideline ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2239939-2
ISSN	1558-7118 ; 1557-2625
ISSN (online)	1558-7118
ISSN	1557-2625
DOI	10.3122/jabfm.2012.03.100181
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Article: Rivastigmine from capsules to patch: therapeutic advances in the management of Alzheimer's disease and Parkinson's disease dementia.

Sadowsky, Carl H / Micca, Joseph L / Grossberg, George T / Velting, Drew M

The primary care companion for CNS disorders

2014 Volume 16, Issue 5

Abstract: Objective: To discuss the pharmacology, mechanism of action, and chemical properties of the cholinesterase inhibitor (ChEI) rivastigmine; to provide a rationale for transdermal delivery and supportive clinical data, along with practical guidance on ... ...

Abstract	Objective: To discuss the pharmacology, mechanism of action, and chemical properties of the cholinesterase inhibitor (ChEI) rivastigmine; to provide a rationale for transdermal delivery and supportive clinical data, along with practical guidance on rivastigmine patch use in Alzheimer's disease and Parkinson's disease dementia. Data sources: Pivotal studies of rivastigmine capsules and patch were identified using PubMed and the rivastigmine US prescribing information. PubMed searches were performed in 2013 using rivastigmine as a keyword. Study selection: English-language articles related to rivastigmine considered of relevance to primary care physicians were included. Data synthesis: Pharmacologic differences exist between rivastigmine and ChEIs. Clinical studies demonstrate symptomatic efficacy of oral rivastigmine across all stages of Alzheimer's disease and mild-to-moderate Parkinson's disease dementia. However, gastrointestinal adverse events limit access to optimal therapeutic doses. Strategies that lower maximum plasma concentrations (Cmax) and prolong time to Cmax, ie, transdermal delivery, may improve tolerability. Clinical registration studies have demonstrated improved tolerability of rivastigmine 9.5-mg/24-h patch versus 6-mg twice-daily capsules in mild-to-moderate Alzheimer's disease, and a positive benefit-risk profile of 13.3-mg/24-h versus 9.5-mg/24-h patch in patients needing enhanced efficacy. Clinical data comparing 13.3-mg/24-h versus 4.6-mg/24-h patch in severe Alzheimer's disease demonstrated efficacy on cognition and activities of daily living. These data led to approval of rivastigmine patch in severe Alzheimer's disease. Transdermal delivery also has practical advantages, including simple, once-daily administration and a visual indicator of compliance. Potential application site reactions can be minimized and need not be a barrier to treatment. Conclusions: In addition to practical advantages, rivastigmine patch may improve clinical outcomes throughout the course of Alzheimer's disease by providing access to high-dose efficacy without compromising tolerability.
Language	English
Publishing date	2014
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2127230-X
ISSN	1478-7954 ; 2155-7772
ISSN (online)	1478-7954
ISSN	2155-7772
DOI	10.4088/PCC.14r01654
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Article ; Online: A systematic review of the effectiveness of rivastigmine for the treatment of behavioral disturbances in dementia and other neurological disorders.

Figiel, Gary / Sadowsky, Carl

Current medical research and opinion

2007 Volume 24, Issue 1, Page(s) 157–166

Abstract: Background: Dementia is frequently associated with behavioral disturbances, some of which have a significant impact on patient quality of life and the likelihood of institutionalization. Cholinergic systems, among other neurotransmitters in the brain, ... ...

Abstract	Background: Dementia is frequently associated with behavioral disturbances, some of which have a significant impact on patient quality of life and the likelihood of institutionalization. Cholinergic systems, among other neurotransmitters in the brain, appear to be involved with different behaviors, such as psychosis, depression, agitation, and personality changes. Scope: This paper reviews the clinical data on the effectiveness of rivastigmine, a dual inhibitor of acetylcholinesterase and butyrylcholinesterase, in ameliorating behavioral disturbances in different patient populations. Relevant articles were identified through MEDLINE searches with no date restrictions. Findings: In particular, rivastigmine has shown efficacy in treating behavioral disturbances in patients with a wide range of dementias - Alzheimer's disease, vascular dementia, fronto-temporal dementia, mixed dementia, Lewy body dementia, Parkinson's disease with dementia, and schizophrenia with dementia. Most of the studies have been open-label clinical trials with behavior as a secondary endpoint. The behavior domains that most consistently showed improvement were apathy/indifference, anxiety, delusions (psychosis), and hallucinations. The major limitation of this review is that the effects on behavioral symptoms were usually secondary endpoints in clinical trials. Conclusion: The efficacious effects of treatment with rivastigmine on various behavioral disturbances provide supporting evidence that cholinergic mechanisms, among other neurotransmitters, are involved in the manifestation of some behavioral and psychological symptoms of dementia.
MeSH term(s)	Acetylcholine/physiology ; Cholinergic Fibers/physiology ; Dementia/drug therapy ; Humans ; Mental Disorders/drug therapy ; Nervous System Diseases/drug therapy ; Neuroprotective Agents/therapeutic use ; Phenylcarbamates/therapeutic use ; Rivastigmine ; Treatment Outcome
Chemical Substances	Neuroprotective Agents ; Phenylcarbamates ; Acetylcholine (N9YNS0M02X) ; Rivastigmine (PKI06M3IW0)
Language	English
Publishing date	2007-11-06
Publishing country	England
Document type	Evaluation Studies ; Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ZDB-ID	80296-7
ISSN	1473-4877 ; 0300-7995
ISSN (online)	1473-4877
ISSN	0300-7995
DOI	10.1185/030079908x260961
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Zs.A 955: Show issues

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Article ; Online: Effects of a combined transcranial magnetic stimulation (TMS) and cognitive training intervention in patients with Alzheimer's disease.

Sabbagh, Marwan / Sadowsky, Carl / Tousi, Babak / Agronin, Marc E / Alva, Gustavo / Armon, Carmel / Bernick, Charles / Keegan, Andrew P / Karantzoulis, Stella / Baror, Eyal / Ploznik, Moran / Pascual-Leone, Alvaro

Alzheimer's & dementia : the journal of the Alzheimer's Association

2020 Volume 16, Issue 4, Page(s) 641–650

Abstract: Introduction: This clinical trial evaluates the efficacy and safety of a 6-week course of daily neuroAD™ therapy.: Methods: 131 subjects between 60 and 90 years old, unmedicated for Alzheimer's disease (AD), or on stable doses of an ... ...

Abstract	Introduction: This clinical trial evaluates the efficacy and safety of a 6-week course of daily neuroAD™ therapy. Methods: 131 subjects between 60 and 90 years old, unmedicated for Alzheimer's disease (AD), or on stable doses of an acetylcholinesterase inhibitor and/or memantine, with Mini-Mental State Examination scores between 18 and 26, clinical dementia rating scale scores of 1 or 2, enrolled for a prospective, randomized, double-blind, sham-controlled, multicenter clinical trial. Structural brain MRIs were obtained for transcranial magnetic stimulation targeting. Baseline Alzheimer's disease assessment scale-cognitive (ADAS-Cog) and Clinical Global Impression of Change were assessed. 129 participants were randomized to active treatment plus standard of care (SOC) or sham treatments plus SOC. Results: Subjects with baseline ADAS-Cog ≤ 30 (~85% of study population) showed a statistically significant benefit favoring active over sham. Responder analysis showed 31.7% participants in the active group with ≤ -4 point improvement on ADAS-Cog versus 15.4% in the sham group. Discussion: neuroAD™ Therapy System provides a low-risk therapeutic benefit for patients with milder AD (baseline ADAS-Cog ≤30) beyond pharmacologic SOC.
MeSH term(s)	Aged ; Aged, 80 and over ; Alzheimer Disease/therapy ; Cholinesterase Inhibitors/therapeutic use ; Double-Blind Method ; Female ; Humans ; Male ; Memantine/therapeutic use ; Mental Status Schedule ; Middle Aged ; Prospective Studies ; Transcranial Magnetic Stimulation/instrumentation
Chemical Substances	Cholinesterase Inhibitors ; Memantine (W8O17SJF3T)
Language	English
Publishing date	2020-01-16
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2211627-8
ISSN	1552-5279 ; 1552-5260
ISSN (online)	1552-5279
ISSN	1552-5260
DOI	10.1016/j.jalz.2019.08.197
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Article ; Online: A 24-Week, Open-Label Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of 13.3 mg/24 h Rivastigmine Patch in Patients With Severe Alzheimer Disease.

Farlow, Martin R / Grossberg, George T / Sadowsky, Carl H / Meng, Xiangyi / Velting, Drew M

Alzheimer disease and associated disorders

2015 Volume 29, Issue 2, Page(s) 110–116

Abstract: The long-term safety, tolerability, and efficacy of high-dose 13.3 mg/24 h rivastigmine patch in severe Alzheimer disease was evaluated in a 24-week, open-label extension to the double-blind ACTION study. Safety and tolerability, and efficacy on the ... ...

Abstract	The long-term safety, tolerability, and efficacy of high-dose 13.3 mg/24 h rivastigmine patch in severe Alzheimer disease was evaluated in a 24-week, open-label extension to the double-blind ACTION study. Safety and tolerability, and efficacy on the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV), Severe Impairment Battery (SIB), and ADCS-Clinical Global Impression of Change (ADCS-CGIC) were assessed. Overall, 197 patients continued on 13.3 mg/24 h patch; 199 uptitrated from 4.6 mg/24 h to 13.3 mg/24 h patch. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar in patients who continued on, and patients who uptitrated to, 13.3 mg/24 h patch (AEs: 57.9% and 59.8%; serious AEs: 16.2% and 16.1%; discontinuations: 11.2% and 12.1%, respectively). Larger mean changes from double-blind baseline were observed in patients uptitrated on the ADCS-ADL-SIV (-4.6; SD=8.7) and SIB (-7.0; SD=16.6), than those who continued on 13.3 mg/24 h patch (-3.9; SD=8.0 and -4.7; SD=16.8, respectively). ADCS-CGIC scores were comparable. There were no clinically relevant between-group differences in safety and tolerability. Greater decline was observed in patients with delayed uptitration to high-dose 13.3 mg/24 h patch than patients who continued on high-dose patch.
MeSH term(s)	Accidental Falls ; Activities of Daily Living ; Aged ; Aged, 80 and over ; Alzheimer Disease/drug therapy ; Cholinesterase Inhibitors/administration & dosage ; Cholinesterase Inhibitors/therapeutic use ; Dose-Response Relationship, Drug ; Female ; Humans ; Longitudinal Studies ; Male ; Neuropsychological Tests ; Prospective Studies ; Rivastigmine/administration & dosage ; Rivastigmine/therapeutic use ; Severity of Illness Index ; Transdermal Patch ; Treatment Outcome ; Urinary Tract Infections/chemically induced ; Weight Loss
Chemical Substances	Cholinesterase Inhibitors ; Rivastigmine (PKI06M3IW0)
Language	English
Publishing date	2015-04
Publishing country	United States
Document type	Clinical Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1002700-2
ISSN	1546-4156 ; 0893-0341
ISSN (online)	1546-4156
ISSN	0893-0341
DOI	10.1097/WAD.0000000000000073
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Article ; Online: Evaluating Response to High-Dose 13.3 mg/24 h Rivastigmine Patch in Patients with Severe Alzheimer's Disease.

Farlow, Martin R / Sadowsky, Carl H / Velting, Drew M / Meng, Xiangyi / Islam, M Zahur

CNS neuroscience & therapeutics

2015 Volume 21, Issue 6, Page(s) 513–519

Abstract: Aims: To identify factors predicting improvement/stabilization on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) and investigate whether early treatment responses can predict long-term outcomes, during a trial ...

Abstract	Aims: To identify factors predicting improvement/stabilization on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) and investigate whether early treatment responses can predict long-term outcomes, during a trial of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch in patients with severe Alzheimer's disease (AD). Methods: Logistic regression was used to relate Week 24 ADCS-CGIC score to potential baseline predictors. Additional analyses based on receiver-operating characteristic curves were performed using Week 8/16 ADCS-CGIC scores to predict response (13.3 mg/24 h patch) at Week 24. ADCS-CGIC score of (1) 1-3 = "improvement," (2) 1-4 = "improvement or no change". Results: "Treatment" (13.3 mg/24 h patch) and increased age were significant predictors of "improvement" (P = 0.01 and P = 0.003, respectively), and "treatment" (P = 0.001), increased age (P = 0.002), and prior AD treatment (P = 0.03) for "improvement or no change". At Week 8 and 16, ADCS-CGIC scores of 4 and 5 were optimal thresholds in predicting "improvement," and "improvement or no change," respectively, at Week 24. Conclusions: A significant therapeutic effect of high-dose rivastigmine patch on ADCS-CGIC response was observed. The 13.3 mg/24 h patch was identified as a predictor of "improvement" or "improvement or no change". Patients with minimal worsening/improvement/no change after treatment initiation may be more likely to respond following long-term therapy.
MeSH term(s)	Aged ; Alzheimer Disease/drug therapy ; Cholinesterase Inhibitors/therapeutic use ; Dose-Response Relationship, Drug ; Female ; Follow-Up Studies ; Humans ; Male ; Mental Status Schedule ; Middle Aged ; Predictive Value of Tests ; ROC Curve ; Rivastigmine/therapeutic use ; Treatment Outcome
Chemical Substances	Cholinesterase Inhibitors ; Rivastigmine (PKI06M3IW0)
Language	English
Publishing date	2015-02-10
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2423461-8
ISSN	1755-5949 ; 1755-5930
ISSN (online)	1755-5949
ISSN	1755-5930
DOI	10.1111/cns.12385
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Article ; Online: Efficacy of higher-dose 13.3 mg/24 h (15 cm2) rivastigmine patch on the Alzheimer's Disease Assessment Scale-cognitive subscale: domain and individual item analysis.

Alva, Gustavo / Isaacson, Richard / Sadowsky, Carl / Grossberg, George / Meng, Xiangyi / Somogyi, Monique

International journal of geriatric psychiatry

2014 Volume 29, Issue 9, Page(s) 920–927

Abstract: Objective: Rivastigmine displays dose-dependent efficacy on cognition in patients with Alzheimer's disease (AD), as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). Subanalysis of the OPTIMA (OPtimising Transdermal ... ...

Abstract	Objective: Rivastigmine displays dose-dependent efficacy on cognition in patients with Alzheimer's disease (AD), as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). Subanalysis of the OPTIMA (OPtimising Transdermal Exelon In Mild-to-moderate Alzheimer's disease) study aimed to define ADAS-cog domains by factor analysis of individual items. Efficacy of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch on individual items and newly derived domains was assessed. Methods: OPTIMA was a 48-week, double-blind (DB) study in patients with mild-to-moderate AD. Patients meeting pre-defined decline criteria during open-label treatment with 9.5 mg/24 h patch were randomized in the DB phase to 13.3 mg/24 h (n = 280) or 9.5 mg/24 h (n = 287) patch. ADAS-cog change from baseline was a co-primary outcome measure. Factor analysis categorized ADAS-cog items into newly derived domains. Change from DB-baseline was calculated for domains and individual items. Results: Numerically, less decline was displayed with 13.3 mg/24 h versus 9.5 mg/24 h patch in the total ADAS-cog score at all time points (significant at Week 24, p = 0.027). Factor analysis identified two domains: memory and language. Significantly, less decline was observed on the memory domain with 13.3 mg/24 h versus 9.5 mg/24 h patch at Weeks 12, 24, and 48 (p < 0.05; observed cases). Three items (following commands, orientation, and word recognition) displayed numerically less decline with 13.3 mg/24 h versus 9.5 mg/24 h patch at all time points. No significant between-group differences were observed on the language domain. Conclusion: Results suggest that the greater cognitive efficacy of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch is driven primarily by effects on memory, particularly in the areas of following commands, orientation, and word recognition.
MeSH term(s)	Activities of Daily Living ; Aged ; Aged, 80 and over ; Alzheimer Disease/drug therapy ; Alzheimer Disease/psychology ; Brief Psychiatric Rating Scale ; Cholinesterase Inhibitors/administration & dosage ; Cognition/drug effects ; Dose-Response Relationship, Drug ; Double-Blind Method ; Factor Analysis, Statistical ; Female ; Humans ; Male ; Middle Aged ; Neuroprotective Agents/administration & dosage ; Phenylcarbamates/administration & dosage ; Rivastigmine ; Severity of Illness Index ; Transdermal Patch
Chemical Substances	Cholinesterase Inhibitors ; Neuroprotective Agents ; Phenylcarbamates ; Rivastigmine (PKI06M3IW0)
Language	English
Publishing date	2014-09
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	806736-3
ISSN	1099-1166 ; 0885-6230
ISSN (online)	1099-1166
ISSN	0885-6230
DOI	10.1002/gps.4080
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Article ; Online: Predictors of sustained response to rivastigmine in patients with Alzheimer's disease: a retrospective analysis.

Sadowsky, Carl H / Grossberg, George T / Somogyi, Monique / Meng, Xiangyi

The primary care companion for CNS disorders

2011 Volume 13, Issue 3

Abstract: Objective: The cholinesterase inhibitor rivastigmine is approved for the treatment of mild to moderate Alzheimer's disease. However, it is not possible to predict which individuals will benefit from treatment. This retrospective analysis of an ... ...

Abstract	Objective: The cholinesterase inhibitor rivastigmine is approved for the treatment of mild to moderate Alzheimer's disease. However, it is not possible to predict which individuals will benefit from treatment. This retrospective analysis of an international, 24-week, randomized, double-blind trial aimed to identify the percentage of persons with Alzheimer's disease who have a sustained response with rivastigmine patch, rivastigmine capsules, or placebo; to determine the magnitude of the sustained treatment response; and to investigate baseline patient characteristics predictive of the observed sustained response. Method: Patients who improved on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) at week 16 and maintained at least the week 16 improvement at week 24 were identified as sustained responders. Treatment differences and baseline predictive factors were assessed in patients demonstrating a 1-, 2-, 3-, 4-, or 5-point sustained improvement. The first patient was screened in November 2003 and the last patient completed the study in January 2006. Results: More persons with Alzheimer's disease had sustained improvements on the ADAS-cog and ADCS-ADL with rivastigmine versus placebo. Sustained improvements of 4 or 5 points on the ADAS-cog or ADCS-ADL were demonstrated in the 9.5-mg/24-h rivastigmine patch (24% and 36% of patients, respectively) and 12-mg/d capsule groups (28% on both outcome measures). Factors predictive of a sustained response to treatment included baseline Mini-Mental State Examination, ADAS-cog, and ADCS-ADL scores and treatment, country of treatment, and time since first symptom was diagnosed by a physician. Conclusions: Understanding factors predictive of sustained cholinesterase inhibitor treatment response should help to optimize Alzheimer's disease management and encourage compliance by allowing more realistic expectations of treatment effects.
Language	English
Publishing date	2011-09-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	2675414-9
ISSN	2155-7780 ; 2155-7780
ISSN (online)	2155-7780
ISSN	2155-7780
DOI	10.4088/PCC.10m01101
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Article: Alzheimer's disease diagnosis by detecting exogenous fluorescent signal of ligand bound to Beta amyloid in the lens of human eye: an exploratory study.

Kerbage, Charles / Sadowsky, Carl H / Jennings, Danna / Cagle, Gerald D / Hartung, Paul D

Frontiers in neurology

2013 Volume 4, Page(s) 62

Abstract: We report results of a clinical exploratory human trial involving 10 participants using a combination of a fluorescent ligand and a laser scanning device, SAPPHIRE System, as an aid in the diagnosis of Probable Alzheimer's disease (AD). To the best of ... ...

Abstract	We report results of a clinical exploratory human trial involving 10 participants using a combination of a fluorescent ligand and a laser scanning device, SAPPHIRE System, as an aid in the diagnosis of Probable Alzheimer's disease (AD). To the best of our knowledge, this is the first time that such a technique has been used in vivo of a human lens. The primary goal of the clinical trial, in addition to safety assessment, was to evaluate efficacy of the system. By detecting specific fluorescent signature of ligand bound beta amyloid in the supranucleus (SN) region of the human lens, a twofold differentiation factor between AD patients and Control groups is achieved. Data from our studies indicates that deeper regions of the SN provide the highest measures of ligand bound fluorescence signal from both controls and patients with AD. In addition, we present preclinical studies that were performed to investigate the binding affinity of the ligand to beta amyloid and evaluate the pharmacokinetics of the ligand in rabbit eyes. Further studies are underway involving a larger population for statistical evaluation of the method.
Language	English
Publishing date	2013-05-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2564214-5
ISSN	1664-2295
ISSN	1664-2295
DOI	10.3389/fneur.2013.00062
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