According to a recent research paper, only a marginal percentage of older adults displaying early signs of Alzheimer’s disease are eligible for innovative treatments involving monoclonal antibodies. The study calls for a more expansive set of criteria for clinical trials, as well as greater diversity among participants.
These monoclonal antibody therapies are engineered to target deposits of amyloid-ß in the brain, one of the early markers of Alzheimer’s disease. The study was published in Neurology, the medical journal of the American Academy of Neurology. It is noteworthy that the clinical trial data for these medications is only available for patients in the early symptomatic stages, characterized by mild cognitive impairment or mild dementia due to Alzheimer’s.
At the time the study was conducted, the U.S. Food and Drug Administration (FDA) had granted accelerated approval to two such monoclonal antibodies—lecanemab and aducanumab. Lecanemab, in particular, has since gained full FDA approval based on its demonstrated ability to slow disease progression.
Study author Maria Vassilaki, MD, Ph.D., from the Mayo Clinic and a member of the American Academy of Neurology, emphasized, “While these new treatments offer hope for slowing Alzheimer’s progression, they have primarily been studied in patients in the earliest phases of the disease. The clinical trials’ inclusion and exclusion criteria essentially determine who should or should not receive these medications. Our findings suggest that a limited proportion of older adults with early cognitive deficits due to Alzheimer’s will be candidates for treatment with monoclonal antibodies targeting amyloid-ß in the brain.”
In total, the study assessed 237 individuals aged between 50 and 90 who exhibited mild cognitive impairment or mild dementia and had brain scans revealing elevated levels of amyloid-ß plaques. Eligibility for lecanemab and aducanumab trials was examined based on specific cognitive test scores, body mass index, and other health factors such as history of stroke, cardiovascular disease, or cancer.
For lecanemab, 112 individuals, or 47%, met the initial criteria for clinical trial participation. After applying exclusion factors, such as various health conditions and abnormal brain scan findings, the number shrank to only 19 individuals, or 8%, who were eligible. After amending exclusion criteria to incorporate all with mild cognitive impairment, the eligibility rose to 17%.
In the case of aducanumab, 104 participants, or 44%, met the initial clinical trial criteria. After applying exclusion factors, this number dwindled to just 12 individuals, or 5%.
Vassilaki also highlighted the underrepresentation of older Black and Hispanic adults in clinical trials, despite their higher propensity for Alzheimer’s and other dementias. She stressed the importance of having clinical trials that are representative of all at-risk populations.
Vassilaki concluded, “Our study underscores that merely a small percentage of people in the early stages of Alzheimer’s are candidates for treatment, primarily due to preexisting chronic health issues and brain abnormalities. There is a need for further research to assess the safety and effectiveness of these therapies in larger and more diverse patient populations, as well as in those who are less healthy, before broader treatment can be recommended.”
The study was funded by the National Institutes of Health, the National Institute on Aging, the Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic, the Mayo Foundation for Medical Education and Research, the Liston Award, the GHR Foundation, and the Schuler Foundation. One limitation to note is that the study predominantly included white participants, making the evaluation of eligibility criteria in more diverse populations imperative.
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Frequently Asked Questions (FAQs) about Alzheimer’s Treatment Eligibility
What is the main finding of the study on Alzheimer’s treatment?
The main finding of the study is that only a small percentage of older adults with early symptoms of Alzheimer’s disease are eligible for the new treatments involving monoclonal antibodies.
What therapies are specifically mentioned in the study?
The therapies specifically mentioned are monoclonal antibodies called lecanemab and aducanumab. Lecanemab has received traditional FDA approval, while both initially received accelerated approval.
Which populations were predominantly included in the study?
The study primarily included white participants between the ages of 50 and 90 who exhibited mild cognitive impairment or mild dementia and had elevated levels of amyloid-ß plaques in brain scans.
What did the study suggest about the need for diverse representation in clinical trials?
The study emphasized the necessity for greater representation of diverse populations, particularly older Black and Hispanic adults, who have been traditionally underrepresented in clinical trials.
Why is the study calling for broader clinical trial criteria?
The study calls for broader clinical trial criteria because current criteria significantly limit the number of people who can be treated, often excluding those with chronic health conditions and diverse ethnic backgrounds.
What organizations supported the research?
The research was supported by the National Institutes of Health, the National Institute on Aging, the Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic, the Mayo Foundation for Medical Education and Research, the Liston Award, the GHR Foundation, and the Schuler Foundation.
What limitations does the study acknowledge?
The study acknowledges that it predominantly included white participants. It suggests that assessing eligibility criteria in more diverse populations would be crucial for future research.
What is the next recommended step based on the study’s conclusions?
The study recommends further research to assess the safety and effectiveness of these therapies in larger and more diverse patient populations, as well as in those who are less healthy, before these treatments can be more widely recommended.
More about Alzheimer’s Treatment Eligibility
- American Academy of Neurology Journal
- U.S. Food and Drug Administration (FDA) Accelerated Approval
- National Institutes of Health Funding
- National Institute on Aging Research
- Monoclonal Antibody Treatments for Alzheimer’s
- Mayo Clinic Research on Alzheimer’s Disease
- Alzheimer’s Disease and Ethnic Diversity in Clinical Trials
