Prothena and Walgreens partner to recruit real-world patient population for ASCENT-2 clinical trial in Alzheimer’s disease

Prothena announces collaboration with Walgreens to drive patient awareness, participation and real-world diversity representation in the ASCENT-2 clinical trial of Alzheimer’s drug candidate PRX012.

In April 2023, biotechnology company Prothena announced a partnership with Walgreens to accelerate identification and recruitment of people with Alzheimer’s disease to participate in Prothena’s ASCENT-2 clinical trial of the anti-amyloid beta antibody PRX012. Walgreens’ nationwide community pharmacy presence will facilitate enrolment of a real-world representative population to the ongoing trial to evaluate the efficacy, safety and tolerability of the drug.

It is estimated that more than 6.5M people aged over 65 in the US are living with Alzheimer’s disease. Whilst studies show that Black and Hispanic older adults are at a significantly higher risk for developing Alzheimer’s disease than White older adults, these populations have been historically left out of clinical trials. The Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act has set the objectives of boosting the participation of underrepresented populations in Alzheimer’s and dementia clinical trials.

The US Food and Drug Administration (FDA) has granted a Fast Track designation to Prothena’s PRX012, a potential best-in-class anti-amyloid beta antibody under development for the treatment of Alzheimer’s disease. Phase 1 single ascending dose and multiple ascending dose (MAD) studies have already commenced, and initial data are expected at the end of this year.

Walgreens pharmacy teams operate in almost 9,000 locations, nearly half of which are in socially vulnerable areas. Walgreens will utilize their pharmacy patient-authorized clinical data to identify individuals throughout the US who may be eligible for the Prothena ASCENT-2 MAD clinical trial. They will education potential participants and their caregivers about the trial, either in the pharmacy, at home or digitally, and those interested will be invited to complete a pre-screen to determine eligibility for participation at one of Prothena’s clinical trial sites.

“Alzheimer’s disease is an incredibly complex disorder and requires all stakeholders to work together to develop and evaluate effective therapies,” explained Ramita Tandon, Chief Clinical Trials Officer of Walgreens. “Through Walgreens trusted community pharmacy presence and daily interactions with millions of patients across America, we believe we can have a meaningful impact in helping Prothena with their clinical trial recruitment efforts. Our aim is to help build a more representative patient population for Alzheimer’s research, particularly among underserved and diverse communities, to create a better understanding of this disease.”

“The Alzheimer’s community is at the beginning of a transformational change as more treatment options become available to slow the progression of this devastating and fatal disease. At Prothena, we’re excited about PRX012 and the impact it could have as a next generation Alzheimer’s disease treatment with the potential for more convenient administration for patients and caregivers,” said Hideki Garren, CMO Prothena. “This innovative partnership will allow Prothena to leverage Walgreens’ unique capabilities to engage a broader and more representative patient population for potential enrollment in ASCENT-2 and accelerate the development of the PRX012 program to bring this potential best-in-class anti-amyloid beta antibody to patients as soon as possible.”

Walgreens is amongst a number of retail and community pharmacies moving into clinical trials, including CVS, Walmart and Kroger, helping to make participation in clinical trials more accessible and inclusive.