Across the globe, Alzheimer’s Dementia (AD) is steadily increasing to epidemic proportions with nearly 55 million adults living with Alzheimer’s and other dementias in the world today. It’s the seventh leading cause of death worldwide yet so much remains unknown about the disease. Despite researchers fervently seeking out ways to combat AD, complications inherently associated with dementia like old age, higher rates of comorbidities, and caregiver requirements decelerate progress and lead to difficulties across research.
As of now, strides are being made not only to develop treatments and preventions for the disease, but to better understand Alzheimer’s. One recent study discovered 42 genes linked to the development of AD. These findings unlock the potential to predict a genetic predisposition towards developing Alzheimer’s dementia and opens the door for an advancement in precision medicines and lifestyle management that could alter the trajectory of the disease.
Additionally, groundbreaking advances in AD therapies are suggesting a drastic change in what a dementia diagnosis means in the future. In June of 2021 the FDA accelerated the approval for the first drug developed to treat underlying causes of Alzheimer’s: Biogen’s Aduhelm. Researched on patients with mild signs of dementia, early results in Aduhelm were found to “slow the clinical decline of patients and a reduction in the biomarkers of Alzheimer's dementia pathology” as reported in the study published in March of 2022. Eli Lilly is close behind Biogen with recent findings in a similar Alzheimer’s treatment showing a statistically significant slowing of cognitive and functional decline.
With the rising pressure to put out an Alzheimer’s therapy as soon as possible, the difficulties surrounding dementia research are glaring. Questions around the subjectivity of statistically significant results and controversy surrounding the acceleration of the Aduhelm approval indicate that the race is far from over. The need for highly capable researchers and willing patients remains wanting.
As Inato has worked with sponsors to publish Ahlzeimer’s dementia studies onto our platform, sites across our network have stepped up to join in the fight against this disease. The inherent nature of the disease calls for challenging inclusion criteria and poses barriers for enrollment. Nonetheless, community-based sites with access to naive patient populations and passionate researchers showed an impressive dedication to researching dementia. In a recent Phase III Agitation in Alzheimer’s Dementia trial on our platform, 58% of the sites selected for the trial had previously over-enrolled in similar studies, with several sites having enrolled up to four times more patients than the sponsor had initially requested.
A critical component contributing to barriers in recruiting Alzheimer’s participants is the lack of representation across research staff and participants. Given that Black patients make up only 2% of Alzheimer’s trials yet are twice as likely to be diagnosed as white patients, a shift towards broader inclusivity in AD research is necessary.
In one upcoming Phase II Alzheimer’s trial, our team identified sites with outstanding diversity capabilities. All of these sites had been awarded medals through Inatos’ Inclusive Research program. Eighty percent reported a percentage of their patient database that was more representative of Black individuals than the U.S. population and 60% of the recommended sites had access to a patient population with a higher rate of Latino individuals than the U.S. population. Throughout the site interviews, we collected information surrounding the ethnic and racial breakdowns of the research teams, finding that of the sites Inato recommended to the sponsor for the Phase II Alzheimer’s trial, 100% are run by research teams that reflect the population they serve. This gives the sponsor the confidence that patients are trusting of their research teams, bolstering recruitment and retention rates.
We are proud to work with sites and sponsors dedicated to providing medical innovation to their communities and eradicating the threat of Alzheimer’s. While millions across the globe continue to face the challenges brought on by dementia, Inato is confident that the sites raising their hands to be a part of this research will work passionately alongside sponsors to affect change and bring treatment opportunities to patients everywhere.