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Several years to fill a single early stage trial simply does not seem acceptable any more, and experiments to accelerate recruitment are happening throughout the field. At CTAD, Chris Rowe of Austin Health in Melbourne, Australia, presented an example targeted at prodromal-stage trials. “Our new project addresses the problem that many people are being diagnosed clinically every day, but do not get referred to trials,” he told the audience. Rowe’s site has been doing amyloid PET scans since 2004, and amyloid PET is well-known in Australia but not covered by insurance. What if he could give free amyloid scans to referring clinicians across Melbourne for patients who appear eligible for trials and interested in joining one? In this scheme, a trial sponsor pays for the scans done at Rowe’s center. It is a win for all sides, Rowe said, because the sponsor gets prescreened candidates and reduces the trial’s screen failure rate; the clinician can offer a better diagnosis and some hope when telling his or her patients they have early AD; and the patient gets tangible options for fighting the disease by being pointed toward open clinical trials.

AstraZeneca funded the project, and Rowe’s center fielded referral candidates for scanning who fit the inclusion criteria of AstraZeneca/Lilly’s AMARANTH Phase 3 trial of the BACE inhibitor lanabecestat in early AD. However, referring clinicians were not bound to recommend only this trial to their patients once the scan result was in.

Patients referred from across Melbourne, a city of 4 million, were prescreened by phone and then in person at the city’s Florey Institute of Neuroscience and Mental Health. Over the past 18 months, 64 clinicians referred 342 patients. Of those, 108 failed the telephone screen and 82 failed the on-site screen. Of the 150 who got a PET scan, 115 were positive for amyloid plaques, Rowe said. Of those, the Amaranth trial accepted 41.

Why did half still not get in after that much prescreening? Fourteen people declined when they saw how complex the trial was. Ten had deteriorated, 13 had medical reasons or were on disallowed medications. “I am concerned by these exclusions,” Rowe told the audience. Three more people who had positive NAV4694 scans were negative on a subsequent florbetapir scan done as part of Amaranth. “This is not surprising because florbetapir is less sensitive than NAV4694,” Rowe said (May 2010 news).

An ongoing extension of the program referred 27 additional people to Amaranth. Of the original 115 with positive scans, 32 checked out trials other than Amaranth and 26 of those enrolled. Overall, the program dramatically exceeded the recruitment targets of all the Melbourne AD trial sites, Rowe said. The sponsor’s cost per enrolled person was US$12,000. Importantly, every newly diagnosed patient took up the offer to enter a drug trial. “When people see their scan and hear a diagnosis, they really want to do something about it,” Rowe said.

https://www.alzforum.org/news/conference-coverage/10th-ctad-finally-alzheimers-field-serious-about-prevention-trials#Fill