Key challenges in Alzheimer’s Disease clinical trials are often related to study design and patient recruitment. Statistics show that most Alzheimer’s trials struggle to enroll. When taking into account the inclusion/exclusion criteria, the caregiver, and their family’s role in the study, it is clear that a patient-centric approach must be taken in order to accommodate all parties involved to meet enrollment.
Travel to Site
By age 80, 75% of people with Alzheimer’s and other forms of dementia are expected to be admitted to a nursing home. Many of these patients are cared for by families or unpaid caregivers that may not have access to the resources or vehicles required to transport the patients to research sites for treatment.
To allow the site staff and coordinators to focus on patient care and completing clinical trials, we recommend a strategic partnership between ClinEdge Patient Navigators and the participating sites to enable a positive and personalized experience for these patients. Our patient navigators bring a level of one-on-one attention that has become one of the most effective resources for patients, families, and caregivers.
In addition to the burden on families and caregivers, transporting the patients to the site can cause distress for the patient; they may become confused, agitated, or fearful during the transportation process.
Another option is to conduct your study on-location at the Nursing Home or assisted living facility (ALF). Since 70% of older adults with Alzheimer’s or other dementias are living in nursing homes, it is common for communities to have dedicated units tailored to these individuals. This presents an opportunity for the clinical research industry to explore an alternate strategy by partnering with the nursing home/ALF in order to perform study activities within the comfort of the patients’ units.
By thinking of clinical trial conduct in a different way, we can streamline the process and ultimately generate better data and more successful trials. With BTC Network Integrated Services, we formulate a detailed project plan based on your goals, objectives, and budget to utilize innovative resources to drive success. Using this strategy, our experienced team would:
1. Identify sites with the study staff that have experience in this area OR fill clinical research positions using our expert staffing team to successfully conduct research on-site.
2. Initiate partnerships with nearby nursing homes and facilitate contracting between the nursing home, local vendors, and the site per protocol or study needs.
3. Support the staff on-site to streamline processes and generate better data, leading to robust reporting of enrollment and study performance to sponsor partners in real-time.
Alzheimer’s is the 6th Leading Cause of Death in the US – killing more people than breast cancer and prostate cancer combined.
70% of older adults with Alzheimer’s or other dementias live in the community.
Unpublished tabulations based on data from the Medicare Current Beneficiary Survey for 2011. Prepared under contract by Avalere Health, March 2016.
50% of nursing home residents in 2014 had Alzheimer’s or other dementias, and 61% had moderate or severe cognitive impairment. Nursing home admission by age 80 is expected for 75% of people with Alzheimer’s dementia compared with only 4 percent of the general population.
Harris-Kojetin L, Sengupta M, Park-Lee E, Valverde R, Caffrey C, Rome V, et al. Long-term care providers and services users in the United States: Data from the National Study of Long-Term Care Providers, 2013–2014. National Center for Health Statistics. Vital Health Stat 3 2016;(38):x-xii;1-105
It is estimated that one to four family members act as caregivers for each individual with Alzheimer’s disease. hours of unpaid assistance to those with Alzheimer’s disease and other forms of dementia in the U.S., a contribution to the nation valued at $230.1 billion.