Prodromal Alzheimer’s Clinical Trial

Phase III safety and efficacy in subjects with amnestic mild cognitive impairment due to alzheimer's


O4 was contracted to conduct country wide site and vendor selection, country study set-up, site management and patient recruitment. From previous experience, O4 identified some key challenges at the outset:

Extensive eligibility criteria including a MMSE score more or equal to 24 at screening.

Caregiver requirement, duration of study.

The number of procedures including PET and MRI.

In addition, local start-up delayed by 6 months due to delay in radioligand country specific availability.


O4 EngageTM strategy was employed to develop a comprehensive patient recruitment and site management strategy. A detailed subject recruitment campaign was designed with a patient centric approach as the O4 team recognised that despite its complexity, if pitched correctly the study would be attractive to both patient and caregivers as it represented a potential therapeutic strategy for slowing or halting disease progression.

We identified and ‘set-up’ patient identification centres at neighbouring hospitals.

Strong input and practical assistance was received from patient advocacy groups.

O4 AccelerateTM was deployed to enable the establishment of a rapid and comprehensive pre-screening service via O4’s in-house call centre pre-screening team.


Achieved 90% of country enrolment target in just 3 months (planned enrolment period was 9 months) despite 6 months delay in start-up. The screen failure rate was 4:1 whereas globally this was 17:1.

recruitment rate
reduction in screen failures
vs global average

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