Comments in support of FDA guidance on "Developing Drugs for the Treatment of Early Stage Disease"

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ResearchersAgainstAlzheimer’s agrees with the importance of diagnosis and treatments at much earlier stages of Alzheimer’s disease. This draft guidance is based on the emerging understanding of Alzheimer’s research that treatments aimed at people showing overt functional impairments due to dementia won’t work because the damage to the brain may be too extensive at that point in the progression of the disease. Therefore, the appropriate response to this recently-­developed understanding is, as noted in the well-­considered draft guidance document of the FDA, to rely on a demonstration of a positive impact on cognitive decline along with evidence of the engagement of the underlying disease pathology."