Only a small percentage of older people with early-stage Alzheimer’s disease meet the eligibility criteria for a new monoclonal antibody treatment that targets amyloid-beta plaques in the brain, an early sign of Alzheimer’s disease. The new research will be published online in the August 16, 2023 issue. neurology®, the medical journal of the American Academy of Neurology. Clinical trial results for these drugs are available only in people in the early symptom stages of mild cognitive impairment due to Alzheimer’s disease or mild dementia.
At the time of this study, two monoclonal antibodies called lecanemab and aducanumab had received early approval from the FDA. Most recently, lecanemab, which has been shown to slow disease progression, received conventional FDA approval.
Study author Maria Vassilaki, M.D., said: “It is hoped that these new treatments for Alzheimer’s disease may slow the progression of the disease in many people, but the drug is not effective in people with early-stage Alzheimer’s disease. The fact remains that research has only been conducted on He is a Ph.D. from the Mayo Clinic in Rochester, Minnesota and a member of the American Academy of Neurology. “The clinical trial inclusion and exclusion criteria that led the FDA to early approval of these treatments form the basis of how people should be advised or refrain from taking any of these treatments. In our study, we estimate that only a small percentage of older adults present with early symptoms.Cognitive impairment due to Alzheimer’s disease qualifies for treatment with monoclonal antibodies directed against amyloid-β in the brain. there may be.”
The study involved 237 people aged 50 to 90 who had mild cognitive impairment or mild dementia and had brain scans showing increased amyloid-beta plaques. The researchers then examined the eligibility criteria for clinical trials of lecanemab and aducanumab.
For lecanemab, clinical trial entry criteria required specific scores on various thinking and memory tests and a BMI between 17 and 35. The researchers found that 112 (47%) met the entry criteria to participate in the clinical trial. trial. The researchers then looked at exclusion factors for clinical trials, namely people, including multiple health factors such as stroke, cardiovascular disease, a history of cancer, and brain scan findings that indicated abnormalities such as older minor cerebral hemorrhages or brain injuries. were focused on factors that might prevent them from participating in the trial. Due to insufficient blood supply. The researchers found that only 19 patients, or 8%, were eligible for the lecanemab trial after exclusion.
However, if we changed the exclusion criteria to include all participants with mild cognitive impairment and did not apply the results of the additional memory and thinking skills tests, 17% of the participants with mild cognitive impairment participated in the study. should be subject to
For aducanumab, clinical trial entry criteria required specific scores on tests of thinking and memory, and participants were required to be between the ages of 50 and 85. The researchers found that 104 (44%) would meet the necessary characteristics to participate in clinical trials. The researchers found that 12 people, or just 5%, were excluded from the trial for multiple health factors, including stroke, cardiovascular disease, uncontrolled hypertension, a history of cancer, and brain scan findings. found. Eligible for a trial of aducanumab.
Dr. Vassilaki said older black and Hispanic adults are more likely to suffer from Alzheimer’s disease and other dementias, yet they are underrepresented in clinical trials, and clinical trial participants are at risk for cognitive impairment. He pointed out that it should be representative of everyone who has
Our findings show that only a minority of patients with early Alzheimer’s disease qualify for treatment, largely due to chronic health conditions and brain scan abnormalities common in the elderly. is shown. In general, clinical trial participants are healthier than the general population. Safety and efficacy of monoclonal antibodies targeting amyloid-β plaques in larger, more diverse and even poorly-healthed populations before these therapies become more widely available for Alzheimer’s disease patients. Additional studies are needed to examine ”
Maria Vasilaki, M.D., Mayo Clinic
A limitation of this study was that the participants were predominantly Caucasian. Vasilaki said it will be important to evaluate these eligibility criteria in more diverse populations.
This work was supported by the National Institutes of Health, the National Institute on Aging, the Alexander Family Alzheimer’s Research Professorship at the Mayo Clinic, the Mayo Foundation for Medical Education and Research, the Liston Award, the GHR Foundation, and the Schuler Foundation.
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Reference magazine:
Pittock, RR, other. (2023) Eligibility of Anti-Amyloid Treatments in Population-Based Studies of Cognitive Aging. neurology. doi.org/10.1212/WNL.0000000000207770.