HealthDay News — Older adults with cognitive impairment have limited eligibility for anti-β amyloid monoclonal antibodies when applying clinical trial criteria, according to a study published online Aug. 16 in Neurology.
Rioghna R. Pittock, from the Mayo Clinic in Rochester, Minnesota, and colleagues applied the clinical trial eligibility criteria for lecanemab and aducanumab treatment to participants with early Alzheimer Disease from the population-based Mayo Clinic Study of Aging (MCSA). The study sample included 237 MCSA participants with mild cognitive impairment (MCI) or mild dementia and increased brain amyloid burden.
The researchers found that the sample was reduced to 112 participants (47.3 percent) with the lecanemab trial’s inclusion criteria and was further reduced to 19 (8 percent) with the trial’s exclusion criteria. Instead of applying additional cognitive criteria, modifying the exclusion criteria to include all participants with MCI resulted in 17.4 percent of participants with MCI being eligible for lecanemab. Overall, 104 participants met the clinical trial inclusion criteria for aducanumab (43.9 percent). The number of eligible participants was further reduced to 12 (5.1 percent) with the aducanumab trial’s exclusion criteria. Chronic conditions and neuroimaging findings were common exclusions.
“Our study results show only a small percentage of people with early Alzheimer’s disease may be eligible to receive treatment, mostly due to chronic health conditions and brain scan abnormalities common in older adults,” study author Maria Vassilaki, M.D., Ph.D., also of the Mayo Clinic, said in a statement. “Additional research is needed to examine the safety and efficacy of monoclonal antibodies targeting amyloid-β plaques in larger, more diverse populations.”
Several authors disclosed ties to the pharmaceutical industry.
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