Neurology Case Study: Problem Solving for Uninterrupted Trial Progress


Prodromal Alzheimer’s Disease Rescue Case Study


The Challenge

Worldwide Clinical Trials (a prominent Alzheimer’s Disease CRO) was retained to intervene in a Phase IIb, multinational, randomized, double-blind, placebo-controlled study, in subjects with progressive cognitive decline compatible with the diagnosis of prodromal Alzheimer’s Disease (AD).

For this highly complex study, the original CRO had failed to meet enrollment expectations due to inadequate vetting of site capabilities for this unique diagnostic category which required the use of multiple, sophisticated screening assessments which served as a “gatekeeper” for patient eligibility. The study had been launched in over 30 centers by the sponsor with virtually no patient enrollment prior to Worldwide Clinical Trials’ engagement.

The Solution
  • Dedicated a Worldwide neuropsychologist to oversee clinical monitoring, site selection and enrollment.
  • Structured the sequence of test applications for compatibility with protocol design and standard of care.
  • Reevaluated site attributes and rater qualifications for administration of battery of neuropsychological tests; many of which required specialized training in a highly codified sequence.
The Results
  • Worldwide’s conceptual, operational and assessment services oversaw the study’s extension into neighboring countries.
  • Supervision and training by the Worldwide therapeutic specialist on measures that affected patient eligibility, accelerated patient randomization and the study completed one week prior to the original target date.
  • As acknowledgment of Worldwide’s material contribution to concepts, analysis and implementation of the study, Worldwide scientific staff are co-authors in an accepted article in the Journal of Alzheimer’s Disease.

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