Digital Communities Could Solve Recruiting Challenges for Alzheimer's Trials
By: Lynne Hughes, B.Med.Sci., PhD, PMP | September 11, 2014
By 2015, dementia caused by Alzheimer’s Disease (AD) will affect one in every 85 people worldwide. The financial and emotional impact of this condition is staggering to both patients and their families, and new treatments are desperately needed to help arrest this trend. If interventions were available to delay both disease onset and progression by just one year, there would be almost 9.2 million fewer cases of AD in 2050.
Biopharmaceutical companies around the world are racing to develop therapies that will slow or even stop the progression of AD. But the lack of accessibility to trial participants is frustrating their progress.
Ideally, AD clinical research programs identify patients at an early stage of their disease in the hope of influencing its course using disease-modifying treatments. AD can have a long ‘silent’ phase, with signs of cognitive decline, as assessed by biomarkers., appearing as early as 12 – 20 years before the onset of clinically apparent dementia. The disease then moves to a level where subjects experience only episodic memory challenges with no other easily recognizable symptoms – which is termed prodromal Alzheimer’s (pAD) or Mild Cognitive Impairment (MCI).
Many patients with such early symptoms of AD can be reliably diagnosed in advance of fully manifest dementia. These patients, however, are difficult to find.
It is extremely challenging to identify suitable subjects for inclusion in clinical trials for pAD/MCI. While symptoms are prevalent in the community, patients do not self-identify with these conditions, In surveys we’ve conducted via the online patient community MediGuard.org, no subjects have ever self-reported a diagnosis of pAD, and only five percent have reported a diagnosis of MCI. Results from a similar study of 440 patients across eight possible protocols on MediGaurd.org showed that only 30 percent of patients experiencing at least one symptom of neuro-cognitive decline had ever even visited their physician.
This highlights the challenge our industry faces in attracting patients to trials when they do not align their symptoms with pAD. But it also demonstrates that there is a large available pool of patients who would be appropriate for these trials – if only we can engage them sooner.
Digital patient community outreach may be part of the solution. Our studies show that subjects are willing to complete online assessments regarding their symptoms, and thus a digitally based community outreach pre-screening campaign could help identify and screen potentially appropriate trial subjects, and eliminate inappropriate ones. Such outreach, coupled with positive messaging about the required trial assessments and their potential benefits to subjects and future AD sufferers, may increase the chance that new patients will be successfully recruited into these studies.
Such digital strategies won’t solve all of the recruiting challenges AD researchers face, but it can expand access to a much larger population of potential candidates, which is a critical first step to moving forward with research to slow or even cure this disease.