Alzheimer's drug trial shows 'evidence of sustained improvement' aberdeenuni
At Visits 2, 3, 7 and 10, timed morning blood samples are collected for determination of plasma level of the drug. Samples are collected prior to dosing and then at 1, 2, and 4 hours post dose. A single blood sample for apolipoprotein E genotyping is obtained from participants who provide informed consent at any time after eligibility determination and prior to Visit 7.
Secondary end points to be assessed over the open-label delayed-start period will compare participants originally randomized to placebo with participants originally randomized to either dose of hydromethylthionine mesylate include:Exploratory End PointsTauRx Composite Scale is a new composite designed to be sensitive to decline in early AD constructed on the basis of data available from completed TauRx Phase 3 trials and from Alzheimer’s Disease Neuroimaging Initiative data.
With 200 participants randomized per arm to the primary comparison in the double-blind treatment period, 160 to 170 participants per arm will enter the open-label, delayed-start treatment phase, assuming the 20%–25% dropout rates mentioned above.
The global null versus alternative primary efficacy hypotheses is a Union-Intersection Test which requires both the co-primary end points to show statistical significance at the 5% two-sided level of significance, for the global null hypothesis to be rejected.The LUCIDITY trial protocol has had 3 major revisions motivated by changing regulatory expectations for AD therapies and emerging data.
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Is Carrie Bradshaw Entering Her Barbiecore Phase In The New Season Of And Just Like That?Thanks to Barbie, the new movie starring Margot Robbie, hot pink is back on top. And Carrie Bradshaw agrees. Read more on Grazia.
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It’s official: Carrie Bradshaw is in her Barbiecore phase in the newest season of And Just Like ThatThe latest dispatch from the set of And Just Like That is Carrie Bradshaw wearing pink to make all the Sex And The City fans wink. SexAndTheCity
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Distinct translatome changes in specific neural populations precede electroencephalographic changes in prion-infected miceAuthor summary Prions are infectious agents composed of a misfolded protein. When isolated from a mammalian brain and transferred to the same host species, prions will cause the same neurodegenerative disease affecting the same brain regions and cell types. This concept of selective vulnerability is also a feature of more common types of neurodegenerative diseases, such as Alzheimer’s, Parkinson’s, and Huntington’s. To better understand the mechanisms behind selective vulnerability, we studied disease responses of five cell types with different vulnerabilities in prion-infected mice at two different disease stages. Responses were measured as changes to mRNAs undergoing translation, referred to as the translatome. Before prion-infected mice demonstrated typical disease signs, electroencephalography (a method used clinically to characterize neurodegeneration in humans) revealed brain changes resembling those in human prion diseases, and surprisingly, the translatomes of all cells were drastically changed. Furthermore, before electroencephalography changes emerged, three cell types made unique responses while the most vulnerable cell type did not. These results suggests that mechanisms causing selective vulnerability will be difficult to dissect and that therapies will likely need to be provided before clinical signs emerge and individually engage multiple cell types and their distinct molecular pathways.
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The effect of high-polyphenol Mediterranean diet on visceral adiposity: the DIRECT PLUS randomized controlled trial - BMC MedicineBackground Mediterranean (MED) diet is a rich source of polyphenols, which benefit adiposity by several mechanisms. We explored the effect of the green-MED diet, twice fortified in dietary polyphenols and lower in red/processed meat, on visceral adipose tissue (VAT). Methods In the 18-month Dietary Intervention Randomized Controlled Trial PoLyphenols UnproceSsed (DIRECT-PLUS) weight-loss trial, 294 participants were randomized to (A) healthy dietary guidelines (HDG), (B) MED, or (C) green-MED diets, all combined with physical activity. Both isocaloric MED groups consumed 28 g/day of walnuts (+ 440 mg/day polyphenols). The green-MED group further consumed green tea (3–4 cups/day) and Wolffia globosa (duckweed strain) plant green shake (100 g frozen cubes/day) (+ 800mg/day polyphenols) and reduced red meat intake. We used magnetic resonance imaging (MRI) to quantify the abdominal adipose tissues. Results Participants (age=51 years; 88% men; body mass index=31.2 kg/m2; 29% VAT) had an 89.8% retention rate and 79.3% completed eligible MRIs. While both MED diets reached similar moderate weight (MED: − 2.7%, green-MED: − 3.9%) and waist circumference (MED: − 4.7%, green-MED: − 5.7%) loss, the green-MED dieters doubled the VAT loss (HDG: − 4.2%, MED: − 6.0%, green-MED: − 14.1%; p | 0.05, independent of age, sex, waist circumference, or weight loss). Higher dietary consumption of green tea, walnuts, and Wolffia globosa; lower red meat intake; higher total plasma polyphenols (mainly hippuric acid), and elevated urine urolithin A polyphenol were significantly related to greater VAT loss (p | 0.05, multivariate models). Conclusions A green-MED diet, enriched with plant-based polyphenols and lower in red/processed meat, may be a potent intervention to promote visceral adiposity regression. Trial registration ClinicalTrials.gov , NCT03020186
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