An issue of experimental studies is reviewed in view of their possibilities and limitations in assessing bioeffects and health risk of electromagnetic fields (EMFs). Investigations of bioeffets and their consequences are being performed at different levels of biological organization. Experimental studies involving cellular structures and animals lead mostly to the assessment of mechanisms of EMFs interaction and to the observation of possible bioeffects. To assess health risk of exposure to EMFs it is necessary to perform strudies involving human subjects (volunteers) or epidemiological studies targeted at specific human populations. The biological material applied in experiments appears to be a specific measure of the effect exerted by EMFs on the body, but as every measure, it has its own advantages and disadvantages and the obtained results may be burden with some errors, which should be analyzed during the interpretation of experimental study results.
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Background: Availability of amyloid modifying therapies will dramatically increase the need for disclosure of Alzheimer's disease (AD) related genetic and/or biomarker test results. The 21st Century Cares Act requires the immediate return of most medical test results, including AD biomarkers. A shortage of genetic counselors and dementia specialists already exists, thus driving the need for scalable methods to responsibly communicate test results.
View Article and Find Full Text PDFBackground: Clinical trial sponsors rely on research sites to identify and enroll appropriate study participants and to correctly and reliably assess symptom severity and function over the course of the trial. Low-recruiting sites represent a large financial and operational burden and may negatively impact trial success either by selecting inappropriate participants and/or high prevalence of data quality issues. We previously reported that >60% of sites in schizophrenia clinical trials recruited ≤5 participants.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Karolinska Institute, Stockholm, Södermanland and Uppland, Sweden.
Background: Novel anti-amyloid therapies (AAT) for Alzheimer's Disease (AD) have recently been approved in the United States, Japan and China, and are under regulatory review in Europe. Questions remain regarding the long-term effectiveness and value of these drugs when used in routine clinical practice. Data from follow-up studies will be important to inform their optimal use, including criteria for treatment initiation, monitoring strategies, stopping rules, pricing and reimbursement considerations.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Case Western Reserve University, Cleveland, OH, USA.
Background: Traumatic Brain Injury (TBI) is one of the most common nonheritable causes of Alzheimer's disease (AD). However, there is lack of effective treatment for both AD and TBI. We posit that network-based integration of multi-omics and endophenotype disease module coupled with large real-world patient data analysis of electronic health records (EHR) can help identify repurposable drug candidates for the treatment of TBI and AD.
View Article and Find Full Text PDFBackground: Rater change is inevitable in often lengthy clinical trials in Alzheimer's disease. Other groups have previously assessed the impact of rater change on data variability. Their conclusions varied, possibly due to differing methodologies (e.
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