UsAgainstAlzheimer’s Launches AD PACE, New Patient-Caregiver Initiative

UsAgainstAlzheimer’s recently launched the Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE) initiative as a groundbreaking partnership between the public and private sectors to identify and prioritize the needs and preferences of those living with Alzheimer’s disease.

The organization recently held a webinar to present the AD PACE initiative, which will include leading pharmaceutical companies like Biogen, advocacy organizations like the LEAD Coalition, academic institutions like Alzheimer’s Research UK, and federal agency advisers from the National Institutes of Health and the U.S. Food and Drug Administration.

AD PACE members will create a new model for bringing the voice of the Alzheimer’s community into therapy development and the review process, as well as policymaking and care programs.

The AD PACE initiative aims to:

• Deliver a scientifically accurate understanding of what matters most to the Alzheimer’s community;
• Match the scope and pace of the development of FDA patient engagement guidance and policies;
• Become a leading representation of patients’ voices to inform product and clinical trial design, regulatory submissions, and research, among others.

The initiative will initially be focused in the United States but will collaborate with other global partners.

“Developing treatments that can truly help improve patients’ lives should be rooted in a firm understanding of the daily challenges patients face, their needs, and the trade-offs they are willing to make for improved outcomes,” George Vradenburg, chairman of UsAgainstAlzheimer’s, said in a press release.

“To create valuable treatments, patient needs and preferences must be integrated in all aspects of the healthcare system, including research priorities, product development, trial design, regulatory approval, access, reimbursement, and treatment decisions,” Vradenburg added. “The decision-making processes surrounding the disease will benefit immensely from this work.”

The initiative is already producing significant assets, such as the A-LIST, a growing online community for those living with Alzheimer’s disease and other dementias, as well as their former and current care partners, and the AD PACE Data Commons, the first-ever repository that will house data developed through a range of preference studies contributed by nonprofits, universities and the pharmaceutical industry.

The initiative is also producing other features like the AD PACE Studies — a set of studies and surveys designed to produce new knowledge on what matters most to the community; the AD PACE Knowledge Landscape and Technical Assessment — used to assess endpoints informing the AD PACE What Matters Most research, among others;  and the AD PACE Gap Analysis and Tool Kit, which focusing on the tools, scales, and outcomes measures used in Alzheimer’s clinical trials.

AD PACE What Matters Most is a two-part study focused on identifying and quantifying treatment-related needs, preferences, and priorities from people before any cognitive impact but with pathological evidence of Alzheimer’s, to care partners of patients with advanced disease.

The first part of the study will attempt to understand which treatment-related outcomes matter to individuals with Alzheimer’s while the second part will investigate how much each of these outcomes matter to determine which potential outcome matters most.

“AD PACE is clearly grounded in the obvious yet often undervalued premise that every stage of Alzheimer’s drug development should be centrally informed by the preferences and priorities of people living with the disease. Ethically and practically, people living with Alzheimer’s disease deserve an equal seat at the table,” said Ian Kremer, executive director of the LEAD Coalition.

The initiative follows the recently revised FDA draft guidance on developing therapies for the treatment of early Alzheimer’s disease. With the revised draft guidance, the FDA is informing the community about its latest thinking on how to assess a drug’s impact on the trajectory of Alzheimer’s in its earliest stages.

“We know that securing FDA approval for a new therapy is just the first step,” Vradenburg said. “We have designed AD PACE from the beginning in a way that will help payers understand how a new therapy affects not just the lives of those in a clinical trial, but the lives of all of those who are living with Alzheimer’s. We cannot do this work without this goal in mind.”

The AD PACE initiative is expected to be completed by May 2022.