Why do people resist enrolling in clinical trials for Alzheimer’s disease?
Some of the key challenges that researchers face in conducting studies on Alzheimer’s disease and recruiting candidates include barriers such as lack of time, lack of available diagnostic clinical tools and the potential research candidate’s concerns over risks to them of experimental protocols or invasive procedures. Additionally, lack of proximity to a research center, along with the candidate’s comorbidities remain reasons why people are resistant to enroll in Alzheimer’s clinical trials. Further, barriers to participation for underrepresented communities, such as lack of cultural sensitivity, and the requirement for the proposed candidate to have a study partner (someone who can report on cognitive changes) are also roadblocks for enrollment of participants in most Alzheimer’s trials.
To refer an individual for a clinical trial, the physician or clinician must recognize that the individual might have or be at risk for cognitive impairment. However, some studies show that physicians are unaware of cognitive impairment in more than 40% of their cognitively impaired patients. Given the lack of treatment options for the disease, detection of cognitive impairment also offers an opportunity to refer patients to research studies that may contribute to understanding the disease and future treatment options. Yet, there are significant costs associated with screening for cognitive impairment in people older than age 65. A National Institutes of Health–funded study is underway to shed more light on weighing the benefits and harms of dementia screening in a diverse population of older adults attending primary care clinics.
Additionally, according to a 2015 NIH study, clinical trials struggle to include people from diverse racial and ethnic backgrounds, traditionally underrepresented in research participation. Barriers to their participation may include understandable and long-standing mistrust of the medical establishment and local academic research institutions; language; logistical barriers and cost like time and travel; lack of cultural sensitivity and ethnic and cultural similarity of staff to participants; and invasive procedures. These barriers are particularly concerning because many of these groups are considered to be higher risk for dementia. In addition, many studies’ exclusion criteria eliminate people with comorbid conditions that are prevalent in some racial or ethnic groups, such as diabetes and vascular disease.
Specific requirements for clinical trials also complicate candidate recruitment. Some trials may require that the candidate demonstrate a possible Alzheimer’s-like biomarker profile or a “positive” biomarker such as high amyloid burden or genetic risk such as the APOE4 gene.
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