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Some evidence suggests that in AD, dysregulation of tight junction proteins, increased matrix metalloproteinase signaling, and degeneration and loss of pericytes may all contribute to BBB leakage, leading to the accumulation of numerous blood-derived neurotoxic proteins in the brain, causing neuroinflammation and oxidative stress

How the MHRA Assesses a Product MHRA guidance explains that a product may be a medicine when it is presented as treating or preventing disease

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These factors substantially limit the direct extrapolation of robust preclinical efficacy to human clinical setting as large-scale randomized controlled trials with reproductive endpoints are lacking