Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study

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Abstract
This paper reviews the scientific and ethical issues surrounding the conduct of bridging studies in patients with Alzheimer's disease (AD). Bridging studies, so called because they facilitate the transition from phase I to phase II development, are late phase I safety/tolerance studies which determine the maximum tolerated dose (MTD) in patients before initiating phase II efficacy studies. Determining the MTD in patients is important because we have found that AD patients appear to respond to cholinergic compounds differently from normal volunteers, reaching a different MTD. Preliminary evidence of dose-related efficacy with two cholinergic compounds lends support to our contention that determination of the highest tolerated dose maximizes the potential to detect efficacy.

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