Alzheimer’s Disease (AD) is a progressive, irreversible brain disorder that affects memory, thinking, and language skills. Age is the best-known risk factor for AD, with symptoms usually appearing after 60 years of age. According to the Alzheimer’s Association and the Center for Diseases Control and Prevention, the number of people living with AD in the…
Andreas Schreiner
Across all indications, the primary source of trial failure has been—and remains—an inability to demonstrate efficacy.1 An analysis of 640 phase 3 trials with novel therapeutics demonstrated that 54% failed in clinical development. Among those that failed, more than half—57%—failed due to inadequate efficacy.2 In neuroscience indications, an estimated 85% of late phase studies fail,…
Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the…
Researchers have made many attempts at disease modification as they pursue breakthroughs in treating Parkinson’s disease, but so far without success. Why have these efforts failed, and what’s next in treating this degenerative disorder that affects an estimated 10 million people worldwide? We tackled these questions in a Premier Research webcast, The Potential for Disease…