P1–398: Designing the next generation of disease modification trials in people with early Alzheimer's disease: Learnings from recently completed programs in mild‐to‐moderate populations
Year: 2013
Type: article
Abstract: The objective of this symposium is to identify specific methodological issues that need to be addressed as the field advances experimental drug therapies for disease modification of Alzheimer's disease into early AD populations. This symposium is an ISCTM-sponsored session to address several key methodological issues and learnings from recently completed disease modifying drug trials in patients with mild to moderate Alzheimer's disease. The ISCTM is an international society of industry, academic, government and other experts involved in CNS drug development, with a mission to more effectively and efficiently advance the development of novel pharmaco-therapeutics to address the most pressing medical needs of patients with psychiatric and neurological conditions. The Society is fortunate to have the active participation of US, Europe and Japan regulatory experts, who provide relevant input into the methodological challenges influencing the design and outcomes of development programs. Key methodological issues to be addressed in this session include patient selection criteria, the appropriateness and adequacy of currently available outcome measures for use in early AD populations, the relevance and utility of various biomarkers for population identification and inclusion as well as for quantifying disease progression and treatment outcome, and the potential to apply adaptive design components to future trials and programs. Additionally, the operational challenges associated with implementing large, multinational trials in Alzheimer's disease will be reviewed, with specific consideration for future trials in a novel population (early AD patients). The session will end with commentary and perspective provided by an experienced researcher and investigator involved in a recently completed disease modifying immunotherapy program. It is imperative that methodological issues be identified and appropriately addressed in order to enhance the probability of success as the field moves forward into the long term investigation of earlier therapeutic interventions. We cannot afford to repeat the mistakes of the past.
Source: Alzheimer s & Dementia
Language: English
Subfield: Physiology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2033299193