Clinical trials in Alzheimer’s disease face mounting challenges in identifying appropriate participants at the earlier stages of cognitive decline, resulting in logistical complexity, increased costs and delayed trial enrollment. Further, sponsors lack real-time visibility into clinical trial recruitment status, so progress against enrollment goals is fragmented across the multitude of trial sites and geographies; often uncorrected until studies miss major milestones.
Cogstate Prescreen is an innovative solution for recruiting patients with specific levels of cognitive impairment. It allows sponsors to better profile potential participants using questionnaires and cognitive testing, those participants most likely to qualify are assigned to a study site in their area and their progression through the recruitment process is centrally tracked for greater insights on which recruitment strategies are working best.
- Flexible integration with recruitment processes across clinical trial sponsors, CROs, clinical sites
- Scalable and modular functionality allows the system to be imbedded in new or existing study websites, and enabling multiple workflows to suit the unique needs of the study
- Reporting dashboards reveal real-time progress against enrollment goals
Growing understanding of Alzheimer’s disease (AD) pathology and the availability of fluid and neuroimaging biomarkers has increased the emphasis of clinical trials toward earlier intervention in the disease. Accordingly, clinical trials have begun to investigate the effects of putative disease modifying and symptomatic treatments in older adults who meet criteria for prodromal AD (also term mild cognitive impairment due to AD, [MCI]). Secondary prevention trials have even begun in individuals in the preclinical stage of AD. While early intervention holds great promise for changing the course of AD, the focus on early disease stages has raised challenges for recruitment. It has proven difficult to locate and identify individuals who have very early AD who could be given access to these new trials. Therefore clinical trial recruitment must now be extended beyond conventional approaches. Outreach strategies should now be aimed at finding those individuals at risk for early AD in the community and compelling them to participate in trials in their area. With this strategy, on-site screen failure rates are likely to be very high and the recruitment processes long and costly.
In response to these challenges, Cogstate has developed an web-based screening tool, the centerpiece of which is the Cogstate Brief Battery measuring psychomotor function, attention, learning and working memory and upon which performance is not affected by culture, language or socioeconomic status. The Cogstate Brief Battery has been shown in many published studies to be sensitive to cognitive impairment and cognitive decline in the preclinical, prodromal (MCI due to AD) and clinical stages of AD and has been used as an endpoint in clinical trials evaluating new disease modifying and symptomatic treatments for AD. In developing Cogstate Prescreen, both the cognitive tests and the user experience have been optimized so that the assessment can be effectively delivered on-line using a variety of modalities (PC, Mac, tablet device). Individuals can participate in prescreening whilst unsupervised in their home, workplace, and community center or wherever they have access to a computer and the internet. Once the brief screening is complete, computer systems automatically analyze data, generate feedback and to direct individuals to pre-determined clinical trials sites, where more formal screening can occur. This approach, combined with direct community outreach programs, dramatically increases the number of individuals who can consider clinical trial participation and provides a sound foundation and support for the modern recruitment strategies that AD trials require.