Alzheimer's disease (AD) is a devastating illness that causes enormous emotional stress to affected families and is associated with substantial medical and nonmedical costs.
To determine the effects of 28 weeks of memantine treatment for patients with AD on resource utilisation and costs.
Multicentre, prospective, double-blind, randomised, placebo-controlled clinical trial performed in the US. The Wilcoxon-Mann-Whitney test was used to examine the resource utilisation variables and logistic regression models were used for multivariate resource utilisation analyses. Analysis of covariance (ANCOVA) models (log and non-log) were computed to examine costs from a societal perspective. All costs were calculated in 1999 US dollars. Study population: Outpatients with moderate to severe AD. Overall, 252 patients received randomised treatment, and 166 patients (placebo n = 76, memantine n = 90) formed the treated-per-protocol (TPP) subset for the health economic analyses, on which the main cost analysis was based.
Resource Utilisation in Dementia (RUD) scale, measuring patient and caregiver resource utilisation, and various sources for cost calculations.
Controlling for baseline differences between the groups, significantly less caregiver time was needed for patients receiving memantine than for those receiving placebo (difference 51.5 hours per month; 95% CI -95.27, -7.17; p = 0.02). Analysis of residential status also favoured memantine: time to institutionalisation (p = 0.052) and institutionalisation at week 28 (p = 0.04 with the chi-square test). Total costs from a societal perspective were lower in the memantine group (difference dollars US 1089.74/month [non-overlapping 95% CI for treatment difference -1954.90, -224.58]; p = 0.01). The main differences between the groups were total caregiver costs (dollars US-823.77/month; p = 0.03) and direct nonmedical costs (dollars US-430.84/month; p = 0.07) favouring memantine treatment. Patient direct medical costs were higher in the memantine group (p < 0.01), mainly due to the cost of memantine.
Resource utilisation and total health costs were lower in the memantine group than the placebo group. The results suggest that memantine treatment of patients with moderate to severe AD is cost saving from a societal perspective.
"Secondary outcome measures are commonly used in dementia trials to assess behavioral  and economic outcomes . These secondary outcomes provide additional insight into drug effects but are not included in the package insert description of an approved agent. "
[Show abstract][Hide abstract] ABSTRACT: Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia (FTD). Targets for intervention have been identified, therapies are being developed, and clinical trials are advancing. A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous phenotypes. The neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction, language impairments and behavioral disturbance. Behavioral variant FTD is characterized by an initial presentation of changes in personality, behavior and/or emotion, which are often difficult to objectively capture using traditional neuropsychological measures. The two principal language variants of FTD are Progressive Nonfluent Aphasia (PNFA) with predominant agrammatic/non-fluent impairments and Semantic Dementia (SD) with semantic impairments and visual agnosia. Selection of appropriate endpoints for clinical trials is critical to ensure that the measures are adequately sensitive to detect change, yet specific enough to isolate signal from noise, and acceptable to regulatory agencies. Given the anticipated potential for small effect sizes, measures must be able to identify small incremental changes over time. It is also imperative that the measures provide adequate coverage of the constructs or behaviors of interest. Selected outcome measures should be suitable for repeat administration, yet relatively robust to practice effects to ensure that observed changes reflect true signal variance and not residual effects due to repeated measurement or poor reliability. To facilitate widespread adoption as an endpoint, measures should be readily accessible. We provide several examples of potential global, composite, and individual cognitive measures, as well as behavioral measures promising for FTD trials. Development and application of appropriate trial outcomes is critically important to success in advancing new treatments for FTD patients.
"It is assumed that any benefits of treatment that have the ultimate effect of maintaining patient independence would alleviate the burden on the caregiver, making caregiving easier, and ultimately delaying the move to institutional care. Memantine has been shown to significantly reduce the time spent caring by ~51 h/month, equivalent to 1.7 h/day (Wimo et al., 2003). As many caregivers provide >10 h of care each day (Georges et al., 2008), a reduction in caregiver time of this magnitude would significantly relieve the burden of caring. "
[Show abstract][Hide abstract] ABSTRACT: As Alzheimer's disease (AD) progresses, patients become increasingly dependent on others, placing a substantial impact on the daily lives of patients and caregivers. A treatment that slows clinical progression is a realistic and meaningful therapeutic goal for patients and caregivers. If given early, such a treatment would be expected to maximise any potential benefit. Memantine has shown clinical benefits in the key domains of AD, both as monotherapy and in combination with a cholinesterase inhibitor (ChEI).
Memantine now has a considerable database of published studies and is associated with benefits in aspects of behaviour, cognition and communication, and on clinical progression. The results of these clinical studies are reviewed.
Short-term clinical studies (≤28 weeks) have shown that memantine reduces clinical worsening and has also demonstrated positive effects in aspects of cognition--language, memory, praxis, functional communication--and in activities of daily living. Furthermore, memantine has been shown to reduce the rate of emergence of troublesome behaviour in patients with AD who were asymptomatic at baseline. Long-term follow-up studies (>1 year) have shown that the benefits of memantine are sustained and increase over time, and that memantine can delay nursing home placement in patients with AD.
These findings provide evidence for the benefits of memantine, either alone or in combination with a ChEI, in slowing clinical progression in AD, and indicate that early treatment initiation may maximise clinical success. The benefits of memantine increase over time, allowing patients to remain independent for longer, alleviating caregiver burden and delaying institutionalisation.
International Journal of Geriatric Psychiatry 08/2012; 27(8):769-76. DOI:10.1002/gps.2788 · 2.87 Impact Factor
"Two post-hoc analyses were derived from this study. In a cost analysis by Wimo et al, it was demonstrated that resource utilization and total health costs were lower in the memantine-treated group compared to placebo.39 Further analysis of resource utilization showed that caregiver time for patients receiving memantine was significantly less than those receiving placebo (difference of 51.52 hours per month; 95% CI −95.27, −7.17). "
[Show abstract][Hide abstract] ABSTRACT: Alzheimer's disease is the most common cause of dementia in older adults. The clinical features include progressive memory decline as well as cognitive deficits with executive dysfunction, language, visual perceptual difficulties, apraxia and agnosia. During the moderate to severe stage of the disease, there is a major decline in memory and function, while neuropsychiatric disturbances often emerge and patients become difficult to manage. These distressing symptoms increase caregiver burden and add to the direct costs of care of the patients. Any improvements in patient function and behavioral symptoms can reduce caregiver burden. Memantine has been available for a number of years in Europe and in North America. In this article, we examine the pharmacological rationale for its use, and the current clinical evidence for its efficacy and long-term effectiveness in the management of cognitive and behavioral symptoms in moderate to severe stages of Alzheimer's disease.
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