Q&A with Natalia Drosopoulou: Important Implications of NIA-AA Framework for Alzheimer’s Disease Research – Part 1 of 3

National Institute of Aging and Alzheimer’s Association Framework for Alzheimer’s Disease Research
By Editors of Talking Trials,

  In 2017, the National Institute of Aging and Alzheimer’s Association (NIA-AA) proposed a common research framework to help clinical investigators establish a research agenda and evaluate the impact of various therapeutics in the Alzheimer’s disease (AD) continuum, and specifically to define and stage AD and facilitate research reporting. 

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Uncommon Patient Recruitment Strategies in Alzheimer’s Disease Clinical Trials – Part 3

Early phase Alzheimer’s disease clinical trial enrollment

As recounted in part one  and part two of “Uncommon Patient Recruitment Strategies in Alzheimer’s Disease Clinical Trials”, clinical trial enrollment in early phase Alzheimer’s disease (AD) clinical trials imposes heavier management burdens due to the number of clinical sites and cohorts, or groups, of patients enrolled per site. Part one of this series reflected on clinical trial enrollment challenges such as sluggish recruitment that can result from overburdened clinical site personnel, while part two discussed how Worldwide Clinical Trials began to develop a technology assisted cohort optimization strategy to reinvigorate recruitment and ensure efficient patient enrollment strategies.

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Uncommon Patient Recruitment Strategies in Alzheimer’s Disease Clinical Trials – Part 2

Early Phase Alzheimer’s disease clinical trial recruitment

  In part one of “Uncommon Patient Recruitment Strategies in Alzheimer’s Disease Clinical Trials”, Talking Trials discussed the recent clinical trial enrollment challenges for early phase Alzheimer’s disease clinical trials. Though not traditionally considered, the exhaustion level and recruitment fatigue of clinical trial site staff due to fast moving and unpredictable patient enrollment scenarios has become a potential barrier to efficient management of these early phase, or “cohort” studies, which are characterized by a relatively small number of patients being enrolled at each dose or cohort across one or more clinical sites. Too often the result is sluggish recruitment and randomization which leads to missed timelines, potentially putting funding or other critical milestones at risk.

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Unique 4-step approach limits high screen failure in Alzheimer’s disease research – Part 2

Alzheimer’s

As noted in part one of this blog series, Worldwide Clinical Trials takes an uncommonly proactive approach to reducing screen failure in Alzheimer’s disease (AD) research. This strategy is especially useful as early-stage clinical studies make up a growing percentage of Alzheimer’s clinical trials. Worldwide’s uncommonly proactive four-step strategy is initiated at the protocol development stage, carries through into prescreening and pre-randomization by targeting semi-predictable reasons for screen failure in Alzheimer’s clinical trials and improving decision making with a centralized eligibility review system.

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