The journal of nutrition, health & aging
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J Nutr Health Aging · Apr 2009
Biomarkers in clinical trials of Alzheimer disease (AD): what is expected from regulatory agencies?
Biomarkers are key for the different phases of drug development in Alzheimer Disease and in other fields. Traditionally the process of biomarker qualification has been slow, mostly exclusively academic. Regulators were mostly passive spectators. ⋯ This created the opportunity for regulators to move from a passive position to a more active role, as facilitators. However, it is becoming apparent that there is room for even more central roles for regulators in the interactive consortia that are now in place. It is also becoming apparent that regulatory agencies are expected to become highly specialized hubs holding expert "know-how" not easily available elsewhere.
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J Nutr Health Aging · Mar 2009
Randomized Controlled Trial Multicenter Study Comparative StudyCost-effectiveness of post-diagnosis treatment in dementia coordinated by Multidisciplinary Memory Clinics in comparison to treatment coordinated by general practitioners: an example of a pragmatic trial.
With the rising number of dementia patients with associated costs and the recognition that there is room for improvement in the provision of dementia care, the question arises on how to efficiently provide high quality dementia care. ⋯ The study will provide an answer to whether follow-up of dementia patients can best be done in specialised outpatient memory clinics or in primary care settings with regard to quality and costs. It will enable decision making on how to provide good and efficient health care services in dementia.
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J Nutr Health Aging · Mar 2009
Methodological improvements in quantifying cognitive change in clinical trials: an example with single-dose administration of donepezil.
Change in cognitive function in response to a pharmacologic challenge can be observed with greater sensitivity by employing cognitive tests with optimal psychometric properties and a statistical approach that more accurately accounts for individual variability in performance. To demonstrate this approach we examined the cognitive effects of a single acute dose administration of an acetylcholinesterase inhibitor, donepezil, in healthy older adults and in older adults with mild Alzheimer's disease (AD). ⋯ The GMLT detected cognitive improvement following a single, acute dose administration of donepezil in healthy older adults and older adults with mild AD. The choice of cognitive tests designed for repeated administration, as well as an analytic approach that emphasizes individual-level change in cognitive function, provides a sensitive approach to detecting central nervous system drug penetration and activity of cognitive-enhancing agents.
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J Nutr Health Aging · Jan 2009
Cachexia and aging: an update based on the Fourth International Cachexia Meeting.
This manuscript highlights the new developments in the pathophysiology of anorexia, cachexia and sarcopenia, based on presentations given at the Fourth International Cachexia Meeting. It stresses the importance of these conditions in older persons.