August 26, 2014

Alzheimer's & Dementia: The Journal of the Alzheimer's Association - July 2014

Full text articles are available to fee paying members of Alzheimer’s Australia NSW by emailing 

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease
Regulatory qualification of a biomarker for a defined context of use provides scientifically robust assurances to sponsors and regulators that accelerate appropriate adoption of biomarkers into drug development.
The Coalition Against Major Diseases submitted a dossier to the Scientific Advice Working Party of the European Medicines Agency requesting a qualification opinion on the use of hippocampal volume as a biomarker for enriching clinical trials in subjects with mild cognitive impairment, incorporating a scientific rationale, a literature review and a de novo analysis of Alzheimer's Disease Neuroimaging Initiative data.
p. 421-429 
Robustness of automated hippocampal volumetry across magnetic resonance field strengths and repeat images
Low HCV has recently been qualified by the European Medicines Agency as a biomarker for enrichment of clinical trials in predementia stages of Alzheimer's disease. For automated methods to meet the necessary regulatory requirements, it is essential they be standardized and their performance be well characterized.
p. 430-438 
The prevalence of mild cognitive impairment and its etiological subtypes in elderly Chinese
Epidemiologic studies on mild cognitive impairment (MCI) are limited in China.
Using a multistage cluster sampling design, a total of 10,276 community residents (6096 urban, 4180 rural) aged 65 years or older were evaluated and diagnosed with normal cognition, MCI, or dementia.
The prevalence of MCI in elderly Chinese is higher in rural than in urban areas. Vascular-related MCI (MCI-CVD and MCI-VRF) was most common.
p. 439-447 
Addition of MHPG to Alzheimer's disease biomarkers improves differentiation of dementia with Lewy bodies from Alzheimer's disease but not other dementias
Overlapping clinical features make it difficult to distinguish dementia with Lewy bodies (DLB) from Alzheimer's disease (AD) and other dementia types. In this study we aimed to determine whether the combination of cerebrospinal fluid (CSF) biomarkers, amyloid-β42 (Aβ42), total tau protein (t-tau), and phosphorylated tau protein (p-tau), in combination with 3-methoxy-4-hydroxyphenylethyleneglycol (MHPG), could be useful in discriminating DLB from vascular dementia (VaD) and frontotemporal dementia (FTD), as we previously demonstrated for differentiation of DLB from AD.
p. 448-455 
Automatic temporal lobe atrophy assessment in prodromal AD: Data from the DESCRIPA study
In the framework of the clinical validation of research tools, this investigation presents a validation study of an automatic medial temporal lobe atrophy measure that is applied to a naturalistic population sampled from memory clinic patients across Europe.
p. 456-467
Features of the Japanese national dementia strategy in comparison with international dementia policies: How should a national dementia policy interact with the public health- and social-care systems?
The Ministry of Health, Labour, and Welfare of the Japanese national government announced a “Five-Year Plan for Promotion of Measures Against Dementia (Orange Plan)” in September 2012. This article described features of the Japanese dementia strategy in comparison with international dementia policies.
p. 468-476 
A platform for discovery: The University of Pennsylvania Integrated Neurodegenerative Disease Biobank
Neurodegenerative diseases (NDs) are defined by the accumulation of abnormal protein deposits in the central nervous system (CNS), and only neuropathological examination enables a definitive diagnosis. Brain banks and their associated scientific programs have shaped the actual knowledge of NDs, identifying and characterizing the CNS deposits that define new diseases, formulating staging schemes, and establishing correlations between neuropathological changes and clinical features. However, brain banks have evolved to accommodate the banking of biofluids as well as DNA and RNA samples. Moreover, the value of biobanks is greatly enhanced if they link all the multidimensional clinical and laboratory information of each case, which is accomplished, optimally, using systematic and standardized operating procedures, and in the framework of multidisciplinary teams with the support of a flexible and user-friendly database system that facilitates the sharing of information of all the teams in the network. We describe a biobanking system that is a platform for discovery research at the Center for Neurodegenerative Disease Research at the University of Pennsylvania.
p. 477-484
Plasma nutrient status of patients with Alzheimer's disease: Systematic review and meta-analysis
Alzheimer disease (AD) patients are at risk of nutritional insufficiencies because of physiological and psychological factors. Nutritional compounds are postulated to play a role in the pathophysiological processes that are affected in AD. We here provide the first systematic review and meta-analysis that compares plasma levels of micronutrients and fatty acids in AD patients to those in cognitively intact elderly controls. A secondary objective was to explore the presence of different plasma nutrient levels between AD and control populations that did not differ in measures of protein/energy nourishment.
p. 485-502 
Justifying reimbursement for Alzheimer's diagnostics and treatments: Seeking alignment on evidence
The increasing cost of health care combined with expensive new drugs and diagnostics is leading to more frequent gaps between regulatory and subsequent reimbursement approval decisions. As a result, persons with Alzheimer's disease may have difficulty accessing the benefit of medical advances. In contrast to the long history and established structure for drug approval, payer decision making is dispersed, not standardized, and perspectives on necessary evidence and the evaluation of this evidence differ and are often poorly defined. Particularly challenging is how to demonstrate the value of drugs and diagnostics for patients who do not yet have significant functional decline. Although discussions to develop consensus continue, clinical trials should begin to incorporate health system and patient-oriented outcomes. In some situations, additional studies designed to demonstrate value and comparative effectiveness will be needed. Such studies should examine outcomes of representative populations in community settings. To assure scientific advances in diagnosis and treatment benefit in patients, developing evidence to support reimbursement will become as important as obtaining regulatory approval.
p. 503-508

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