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Clinical Conference Rivastigmine versus placebo in hyperhomocysteinemic Parkinson's disease dementia patients. 2008
Barone P, Burn DJ, van Laar T, Hsu C, Poewe W, Lane RM. · Dipartimento di Scienze Neurologiche, Università Federico II di Napoli, Naples, Italy. · Mov Disord. · Pubmed #18581467 No free full text.
Abstract: The effects of rivastigmine versus placebo in Parkinson's disease dementia (PDD) patients with elevated or normal/low plasma homocysteine were determined. In this prospective analysis of a 24-week, randomly assigned, placebo-controlled study of rivastigmine in PDD, subpopulations comprised patients with plasma homocysteine >or=14 micromol/L (elevated) or <14 micromol/L (normal/low). Coprimary outcomes were the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Alzheimer Disease Cooperative Society-Clinical Global Impression of Change (ADCS-CGIC). Secondary outcomes included additional measures of cognition, including attention and executive function, daily function, and neuropsychiatric symptoms. Adverse events (AEs) were monitored. In total, 342 of 541 patients provided samples for analysis, from which 72% had elevated plasma homocysteine. Hyperhomocysteinemic patients showed treatment differences (rivastigmine vs. placebo) of 4.0 on ADAS-cog and 0.7 on ADCS-CGIC (both P < 0.01), and significant treatment differences on secondary outcomes. Rivastigmine- and placebo-treated hyperhomocysteinemic patients (16.5% and 14.6%) discontinued the study because of AEs. Patients with normal/low homocysteine showed no treatment differences on primary or secondary outcomes (1.4 on the ADAS-cog and 0.1 on ADCS-CGIC, both P = ns); 16.7% and 10.3% rivastigmine- and placebo-treated patients discontinued because of AEs. Elevated homocysteine was associated with greater rivastigmine treatment differences than normal/low homocysteine.
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Clinical Conference Improving morning care routines of nursing home residents with dementia. 1999
Rogers JC, Holm MB, Burgio LD, Granieri E, Hsu C, Hardin JM, McDowell BJ. · Dept. of Occupational Therapy, University of Pittsburgh, Pennsylvania 15260, USA. · J Am Geriatr Soc. · Pubmed #10484245 No free full text.
Abstract: OBJECTIVES: This study examined the effectiveness of a behavioral rehabilitation intervention for improving the performance of morning care activities of daily living (ADL) of nursing home residents with dementia. DESIGN: Participants and their caregivers were observed for 5 days each under conditions of Usual Care (naturalistic) and Skill Elicitation (intervention), and for 15 days under Habit Training (intervention follow-up). Observations involved the ADL categories of DRESSING, OTHER ADL, and NO ADL. A 3 x 3 design (condition x ADL category) was used. SETTING: Observations occurred in five proprietary nursing homes in Pittsburgh, Pennsylvania. PARTICIPANTS: The participants were 58 women and 26 men, mean age 82 years (range = 64-97, SD = 6.3), with Probable Alzheimer 's disease (AD) (n = 19) and Possible AD (n = 65), with a mean MMSE score of 6.07. INTERVENTION: Condition 1, Usual Care, was the naturalistic caregiving condition. Condition 2, Skill Elicitation, consisted of an individualized behavioral rehabilitation intervention designed to identify and elicit retained ADL skills. Under Condition 3, Habit Training, the behavioral rehabilitation intervention was continued to reinforce and solidify retained skills and to facilitate further functional gains. MEASUREMENTS: A computer-assisted data collection system was used to document in real-time the assists used by caregivers, the participants' ADL performance, and the participants' responses to caregiving, including disruptive behavior. RESULTS: Compared with Usual Care, during Skill Elicitation participants increased the proportion of time engaged in nonassisted and assisted dressing significantly and increased their overall participation in ADL, with a concomitant significant decrease in disruptive behavior. These functional gains were demonstrated within 5 days of initiating the behavioral rehabilitation intervention and were maintained for 3 weeks during Habit Training. Physical assists were provided for significantly smaller proportions of a morning care session during Skill Elicitation and Habit Training compared with Usual Care. CONCLUSIONS: Even very severely cognitively impaired and functionally disabled nursing home residents can respond to a systematically implemented behavioral rehabilitation intervention. Their rapid response to this intervention suggests that it is alleviating excess disabilities brought on by care patterns rather than retraining ADL task performance. Residents with dementia benefit from behavioral rehabilitation by becoming more appropriately involved in their care and being less disruptive. However, behavioral rehabilitative care takes considerably more time than usual care.
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Article Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. 2008
Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. · Wolfson Centre for Age-Related Diseases, King's College, London, UK. · Curr Med Res Opin. · Pubmed #18674411 No free full text.
Abstract: OBJECTIVE: The aim was to evaluate the efficacy, safety and tolerability of rivastigmine capsules in patients diagnosed with probable vascular dementia (VaD). METHODS: VantagE (Vascular Dementia trial studying Exelon) was a 24-week, multicentre, double-blind study. VaD patients aged 50-85 years were randomized to rivastigmine capsules (3-12 mg/day) or placebo. Efficacy assessments included global and cognitive performances, activities of daily living and neuropsychiatric symptoms. Adverse events were recorded. Additional exploratory analyses determined whether heterogeneity in pathologies and symptoms extended to differential treatment effects. TRIAL REGISTRATION: NCT00099216. RESULTS: 710 patients were randomized. Rivastigmine demonstrated superiority over placebo on three measures of cognitive performance (Vascular Dementia Assessment Scale, Alzheimer's Disease Assessment Scale cognitive subscale, Mini-Mental State Examination; all p< or = 0.05, intent-to-treat population [ITT]), but not other outcomes. Predominant adverse events were nausea and vomiting. Exploratory analyses indicated that older patients (> or =75 years old), assumed more likely to also have Alzheimer's disease (AD) pathology, demonstrated significant cognitive responses to rivastigmine and a safety profile similar to that seen in AD patients. Younger patients, assumed less likely to have concomitant AD pathology, showed no efficacy response and were associated with slight elevations of blood pressure, cerebrovascular accidents and mortality. Rivastigmine-placebo differences in patients with, versus those without, medial temporal atrophy (also suggestive of concomitant AD) showed a numerical difference similar to that seen between the older versus younger patients, but did not attain statistical significance. CONCLUSION: Consistent with trials evaluating other cholinesterase inhibitors, rivastigmine did not provide consistent efficacy in probable VaD. The efficacy apparent on cognitive outcomes was derived from effects in older patients likely to have concomitant Alzheimer pathology. This is supportive of an existing argument that the putative cholinergic deficit in VaD reflects the presence of concomitant Alzheimer pathology.
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Article Excess disability during morning care in nursing home residents with dementia. 2000
Rogers JC, Holm MB, Burgio LD, Hsu C, Hardin JM, McDowell BJ. · Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pennsylvania 15260, USA. jcr+@pitt.edu · Int Psychogeriatr. · Pubmed #10937545 No free full text.
Abstract: Excess disability was examined in 17 nursing home residents with dementia by comparing their performance of morning care tasks under two activities of daily living (ADL) caregiving approaches-a dependence-supportive one under usual care and an independence-supportive one under functional rehabilitation. The results suggest that excess disability in severely cognitively impaired and functionally disabled residents can be reduced by increasing opportunities for independent activity, and substituting nondirective and directive verbal assists for physical assists. Further, the findings indicate that increased independence in ADL can be achieved without increasing disruptive behaviors and can foster appropriate requests for task-related help during caregiving. Functional rehabilitation, however, requires more time than usual care.
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