Alzheimer’s disease (AD) is the leading neurodegenerative disease worldwide and the expected rise in patient numbers is a critical threat to our health care systems. AD is therefore a large and growing burden on healthcare systems in developed countries; meanwhile there has been little significant progress towards an effective treatment. One of the main barriers is that diagnosis tends to happen at a late stage of disease, making it difficult to identify and recruit early onset patients to participate in clinical trials.
Recruiting and retaining clinical trial participants is now the greatest obstacle, other than funding, to developing the next generation of Alzheimer’s treatment.
Geriatricians in particular can play a vital role in advancing the understanding of Alzheimer’s by assessing the cognitive health of their older patients and, when appropriate, encouraging their participation in a clinical trial or other research study. The assessment may be triggered by memory complaints or other symptoms such as word-finding problems. Many cognitive screening tools take 10 minutes or less to administer.
The engagement strategy needs to be improved in the primary care setting, where a large number of undiagnosed patients may be found but significant barriers to engagement have been identified. MOPEAD’s successful Citizen Science and Open House strategies will be improved and evaluated in new countries to extend the findings to different healthcare and cultural settings.
Moreover, barriers to AD trial participation may be lowest among previous participants. These individuals have demonstrated trial-entry eligibility as well as motivation to participate. Indeed many participants are eager to enroll in subsequent studies after trial completion or stoppage. Most protocols will exclude participants from previous trials within a given time frame such as 6 months. More and more frequently, however, protocols for particular treatment modalities such as immunotherapies specify that previous participants in trials of agents in the same treatment class be excluded altogether. Participants in some trials may be excluded from all subsequent studies of potential disease-modifying therapies. Since minority participation in trials is so low, this strategy will not improve the diversity of trial samples.
In addition, there are some registries such as national registries which may be associated with large media campaigns. This kind of registry could utilize clinical networks to boost volunteer enrolment. On the other hand, local registries may provide investigators with particularly valuable tools for developing a proper clinical AD research.
Bearing in mind that AD is a progressive disease and the registries usually collect invariable information, there remains the possibility that the number of individuals eligible for specific trials at the time of registry enrollment is not enough to define proper trial recruitment. A systematic upgrade of registry information will therefore increase the overload on the research team, although it may minimize the recruitment problem.
Once the samples have been collected, it is necessary to evaluate blood-based biomarkers which could significantly improve early diagnosis rates, overcoming the invasiveness and time required for present methods. Therefore, it is important to investigate the use of advanced IT solutions for patient care and follow-up, together with an enhanced campaign to spread the message of the benefits of timely diagnosis to the public, clinicians and relevant stakeholders.
Author: Bartolomé López López
Las opiniones vertidas por el autor son enteramente suyas y no siempre representan la opinión de GMV
The author’s views are entirely his own and may not reflect the views of GMV