NEW YORK — Newly formed patient advocacy organization, the ApoE4 Alzheimer's Alliance, said Tuesday that it has sent a letter to the US Food and Drug Administration calling for increased research into an underrepresented group of patients with the neurological disease.
The organization aims to raise awareness about the role of ApoE4 in Alzheimer's disease. The gene variant, it said, is associated with higher risk of developing Alzheimer's disease, as well as earlier onset and rapid disease progression. Still, ApoE4 patients remain underrepresented in research and underserved in clinical care, according to the group.
In its letter to FDA Commissioner Martin Makary, the ApoE4 Alzheimer's Alliance urged the agency to implement a mandate that all Alzheimer's disease patients be genotyped prior to receiving anti-amyloid antibody treatments so that their individual risk profiles can be assessed.
The group also wants Alzheimer's disease clinical trial participants to be informed of their ApoE status; updates to treatment labeling and prescribing guidelines to outline the elevated risk of amyloid-related imaging abnormalities in ApoE4 patients; and an increase in clinical studies that specifically address the safety and efficacy of anti-amyloid therapies in ApoE4 homozygotes.
"The APOE4 community faces unique challenges that demand immediate attention," Jamie Tyrone, an ApoE4 Alzheimer's Alliance board member, said in a statement. "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."