ApoE4 Alzheimer's Alliance Launches to Advocate for ApoE4 Patients, Urges FDA Action

WASHINGTON, April 29, 2025 /PRNewswire/ -- The ApoE4 Alzheimer's Alliance, a new patient advocacy organization, is launching to amplify the voices of individuals with the ApoE4 gene and work with organizations to enact policy priorities. The Alliance will advocate for the unique needs of this community before U.S. policymakers and the U.S. Food and Drug Administration (FDA), pushing for accelerated progress toward innovative treatments and supportive policies.

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Individuals with the ApoE4 gene are at a significantly higher risk of developing Alzheimer's disease, often experiencing earlier onset, rapid disease progression, and limited therapeutic options. Despite this heightened risk, ApoE4 patients remain underrepresented in research and underserved in clinical care.

The ApoE4 Alzheimer's Alliance is committed to addressing these disparities through:

• Advocacy: Lobbying for increased federal funding for ApoE4-specific research, urging policymakers and the FDA to prioritize ApoE4-targeted therapies, and promoting equitable access to diagnostic testing and care.
  
  
• Education: Raising awareness about the heightened risk for ApoE4 carriers, providing resources and support to patients and caregivers, and engaging with medical professionals to improve ApoE4-specific care protocols.
  
  
• Partnership Building: Collaborating with pharmaceutical companies to advance ApoE4-targeted drug development, partnering with academic institutions to fund cutting-edge research and to amplify lived experiences and policy priorities.
  
  
• Patient Storytelling: Highlighting real-world experiences of APOE4 patients and caregivers to humanize the challenges and drive urgency for action.

In conjunction with its launch, the Alliance has sent an open letter to the FDA Commissioner, Dr. Martin A. Makary, MD, urging the agency to take specific actions to protect ApoE4 patients, particularly considering recent research highlighting the risks associated with current Alzheimer's treatments for this population.

Key points from the letter include:

• Require APOE Genotyping Prior to Treatment: The Alliance calls for a regulatory mandate that all patients considering anti-amyloid antibody treatments undergo APOE genotyping to assess their individual risk profile.
  
  
• Mandate Full Disclosure of Genetic Risk in Clinical Trials: The letter emphasizes the need for transparency, ensuring that participants in clinical trials are informed of their APOE status.
  
  
• Enhance Risk Communication in Practice: The Alliance advocates for updated labeling and prescribing guidelines that explicitly outline the elevated ARIA risk in ApoE4 carriers.
  
  
• Support Targeted Clinical Trials: The letter urges the FDA to encourage and facilitate clinical trials that specifically address the safety and efficacy of anti-amyloid therapies in APOE4 homozygotes.

"The APOE4 community faces unique challenges that demand immediate attention," said Jamie Tyrone, Board Member of the ApoE4 Alzheimer's Alliance. "Our goal is to drive meaningful change by advocating for research, access to care, and policies that address the specific needs of ApoE4 patients and their families."

The ApoE4 Alzheimer's Alliance is committed to working collaboratively with all stakeholders to accelerate progress in Alzheimer's research and improve the lives of those affected by this devastating disease.

About ApoE4 Alzheimer's Alliance:

The ApoE4 Alzheimer's Alliance is a patient advocacy organization dedicated to representing the interests of ApoE4 Alzheimer's patients. The Alliance advocates for tailored treatment strategies, increased research funding, and equitable access to care for this high-risk population.

SOURCE ApoE4 Alzheimer's Alliance