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HHS/NIH proposed changes for registering, reporting clinical trial information

Today, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health.

Groundbreaking Alzheimer’s model in petri dish points to amyloid as disease trigger

NIA-supported researchers recently developed an innovative method to culture human brain cells in the laboratory and then modeled, for the first time, the cascade of cellular changes involved in the onset and progression of Alzheimer’s disease. The findings support the “amyloid hypothesis,” a 30-year-old theory that the build-up of beta-amyloid protein in the brain kick starts the toxic changes that lead to tau tangles, and ultimately, cell death. The results by researchers at Massachusetts General Hospital (MGH), Boston, were published online Oct.

Loss of the sense of smell may predict mortality risk among older people

Frailty and dementia often signal increased risk for mortality among older people. But can the loss of olfaction—the sense of smell—also be a significant indicator of mortality risk? An NIH-supported study involving thousands of older people showed those who could no longer detect or distinguish odors were four times more likely to die within five years than those with normal olfaction. The findings are the first to indicate the importance of olfaction in mortality risk for older adults.

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