Multicenter evaluation of new instruments for Alzheimer's disease clinical trials: summary of results. The Alzheimer's Disease Cooperative Study.
NYU Medical Center, Aging and Dementia Research Center, New York 10016, USA.Alzheimer Disease and Associated Disorders (Impact Factor: 2.44). 02/1997; 11 Suppl 2:S65-9.
The Instrument Development Project of the Alzheimer's Disease Cooperative Study (ADCS) evaluated new assessments in five domains: (a) cognitive function; (b) clinical global change; (c) activities of daily living; (d) behavioral symptoms, and (e) cognition in severely impaired patients. These new instruments demonstrate excellent discrimination between normal controls and patient groups and show adequate validity and reliability. Stability of measurement and sensitivity to longitudinal change were also demonstrated in each of these areas. Examination of several domain-specific questions also contributed new information on the measurement of cognitive function with different subtasks across AD severity levels, the stability of clinical ratings of global change, and the applicability of behavioral assessment across severity levels. The success of this project enhances the state of the art in the measurement of efficacy in AD clinical trials and also provides a basis for future research on improving AD outcome measures.
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ABSTRACT: In patients with moderately severe to severe Alzheimer's disease, the N-methyl-D-aspartate (NMDA) antagonist memantine has been shown to improve outcomes and to be associated with reductions in resource utilisation and total healthcare costs relative to no pharmacological intervention after 28 weeks in phase III clinical and pharmacoeconomic studies. However, the longer term cost implications of treatment with memantine are not known. To evaluate the effect of treatment with memantine in patients with moderately severe to severe Alzheimer's disease on resource use and on cost and patient outcomes in Finland over a 5-year time horizon. A Markov model was constructed to simulate a patient's progression through a finite series of health states with a time horizon of 5 years. The states were defined in terms of physical dependency, place of residency (community or institution), and cognitive function. Each 6-month Markov cycle was repeated ten times. A 5% rate was used to discount costs. Inputs for the model were derived from epidemiological data collected during the Kuopio 75+ Study, a Finnish population-based health survey of dementia and functional capacity among in-dividuals aged >/=75 years. Costs were considered from a societal perspective. Probabilities used in the model, together with cost and resource use differences between treatment with memantine (Ebixa((R)), Namenda((R)), Axura((R))) and no pharmacological intervention, were derived from a randomised, double-blind, placebo-controlled clinical trial that included an economic assessment. This study enrolled 252 patients with moderately severe to severe Alzheimer's disease. We took a conservative approach that assumed that the effectiveness of treatment with memantine was limited to 12 months' duration. Monte Carlo simulations were performed to evaluate the effect of treatment with memantine on duration of independence and time to institutionalisation. Sensitivity analyses included memantine efficacy best- (5 years) and worst- (6 months) case scenarios, and an analysis in which 5% discounting was not applied. Memantine therapy was associated with approximately 4 extra months of independence, 1 additional month of residence in the community, and a cost reduction relative to placebo of approximately euro1700 per patient over 5 years, despite the limiting of persistence of efficacy to 12 months (year of costing, 2001). Monte Carlo simulations and sensitivity analyses supported the findings. According to the model, over 5 years the additional drug costs of treating patients with moderately severe to severe Alzheimer's disease with memantine were amply offset by cost savings related chiefly to increased independence and delayed institutionalisation.Clinical Drug Investigation 02/2004; 24(7):373-84. DOI:10.2165/00044011-200424070-00001 · 1.56 Impact Factor
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ABSTRACT: Alzheimer's disease (AD) is associated with neuropsychologic and neuropsychiatric dysfunction and is a leading cause of disability among the elderly. Impairments in activities of daily living (ADL) contribute significantly to the disability reported among patients with AD and diminish quality of life for patients and their families. ADL assessment represents an important component of the diagnosis, tracking, and management of AD. Further, an understanding of the determinants of ADL dysfunction is critical for the early identification of individuals at risk for functional disability and for improved patient care. This manuscript reviews methods for assessing ADL in patients with AD and summarizes the available literature on the neuropsychologic and neuropsychiatric correlates of functional impairment in AD. The emerging role of frontal system dysfunction as an important determinant of ADL impairment is discussed, and recommendations for clinical practice and future research are provided.Current Psychiatry Reports 03/2004; 6(1):20-4. DOI:10.1007/s11920-004-0033-9 · 3.24 Impact Factor
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ABSTRACT: Abstract Diagnosis of dementia in adults with intellectual disabilities requires documentation of clinically significant declines in memory and other cognitive skills, as well as changes in everyday and emotional functioning. To improve diagnostic accuracy in adults with Down syndrome, the authors examined conditions often associated with dementia, as well as tests useful for documentation of decline. Specific aims were to identify psychiatric disorders or medical conditions that increased the odds of a dementia diagnosis; to evaluate the sensitivity and specificity of widely used dementia scales; and to determine which tests, used singly or in combination, most accurately supported the presence of dementia. Participants were 78 adults with Down syndrome. Two methods based on a large test battery and one method based on clinical judgment were used to diagnose dementia. It was found that combinations of tests lead to increased levels of diagnostic sensitivity compared with single tests. When taken in combination with other investigations, our results suggest that assessment for psychiatric disorders, delayed memory decline, adaptive behavior decline, and the presence of seizures would be useful for the diagnosis of dementia and that dementia scales would provide additional useful information. The authors conclude that combinations of tests and scales will be most useful for diagnosing dementia in adults with intellectual disabilities. The authors suggest that further research is needed to promote rapid progress, with studies that focus on common diagnostic methodology, identification of screening instruments, and amounts of decline indicative of dementia.Journal of Policy and Practice in Intellectual Disabilities 02/2005; 2(1):47 - 56. DOI:10.1111/j.1741-1130.2005.00007.x · 0.97 Impact Factor
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