Eligibility for Anti-Amyloid Treatment in a Population-Based Cohort Study of Aging (P5-6.006)

Abstract

<h3>Objective:</h3> To apply the aducanumab clinical trials’ eligibility criteria to the Mayo Clinic Study of Aging (MCSA) participants to understand the application of the eligibility criteria and generalizability of this anti-amyloid treatment in Alzheimer’s Disease (AD). <h3>Background:</h3> Aducanumab is a monoclonal antibody targeting amyloid beta. While Alzheimer’s is the most common form of dementia, inclusion and exclusion criteria in clinical trials may limit the number finally eligible for treatment. Understanding treatment generalizability is crucial. The MCSA is a relevant study population because of the clinical phenotyping, detailed medical history, and availability of neuroimaging including amyloid PET. <h3>Design/Methods:</h3> MCSA is a population-based cohort study of cognitive aging in Olmsted County (MN); 2152 MCSA participants (aged 50–90) had MRI and amyloid PET. We applied available inclusion and exclusion criteria from EMERGE and ENGAGE to assess how many participants would be eligible for aducanumab. <h3>Results:</h3> Participants with cognitive impairment (MCI; n=366) or mild dementia (n=30) were evaluated for inclusion, a subset of 240 (60%) participants with cognitive impairment had a positive amyloid PET scan (SUVR ≥ 1.48). 96 of the 240 (40%) participants fulfilled the trial inclusion criteria (i.e., age 50 to 85 years, ≥ 6 years of education, CDR global = 0.5, and MMSE ≥ 24). The mean age (standard deviation) was 78.4 (5.1) years, 56 (58.3%) were male, and 52 (55.3%) were apolipoprotein E ɛ4 positive. Exclusion criteria such as history of cancer (25 (26.0%)), neuroimaging abnormalities (33 (34.4%)), and uncontrolled hypertension (17 (17.7%)) further narrowed the eligible patients from 96 to 28 (29.2%). <h3>Conclusions:</h3> Eligibility criteria eliminated 88.3% of the MCI/mild dementia participants with positive PiB PET, mainly due to other chronic conditions and neuroimaging findings. Findings highlight major concerns on the eligibility for treatments excluding those with common conditions to the typical older patient populations. <b>Disclosure:</b> An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech, Inc.. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Therapeutics, Inc.. The institution of an immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astellas. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prime Therapeutics. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche/Genentech. The institution of an immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of an immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedImmune/Viela Bio. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB, Inc.. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. An immediate family member of Miss Pittock has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann/LaRoche AG. An immediate family member of Miss Pittock has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for F. Hoffmann/LaRoche. The institution of an immediate family member of Miss Pittock has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. The institution of an immediate family member of Miss Pittock has received research support from Grifols. The institution of an immediate family member of Miss Pittock has received research support from NIH. The institution of an immediate family member of Miss Pittock has received research support from Viela Bio.MedImmune/Horizon. The institution of an immediate family member of Miss Pittock has received research support from Alexion Pharmaceuticals. The institution of an immediate family member of Miss Pittock has received research support from F. Hoffmann/LaRoche/Genentech. An immediate family member of Miss Pittock has received intellectual property interests from a discovery or technology relating to health care. An immediate family member of Miss Pittock has received intellectual property interests from a discovery or technology relating to health care. Jeremiah Aakre has nothing to disclose. Anna Castillo has nothing to disclose. Dr. Ramanan has nothing to disclose. The institution of Dr. Jack has received research support from NIH. The institution of Dr. Jack has received research support from Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic. Dr. Vemuri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Miller Medical Communications Inc.. The institution of Dr. Vemuri has received research support from NIH. Dr. Knopman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for DIAN TU study. The institution of Dr. Knopman has received research support from NIH. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nestle. Dr. Petersen has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech, Inc.. Dr. Petersen has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche, Inc.. Dr. Petersen has received publishing royalties from a publication relating to health care. Dr. Petersen has received publishing royalties from a publication relating to health care. Dr. Graff-Radford has received personal compensation for serving as an employee of Mayo Clinic. Dr. Graff-Radford has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for NINDS/NIH. Dr. Graff-Radford has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Academy of Neurology. The institution of Dr. Graff-Radford has received research support from NIH. The institution of Dr. Vassilaki has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for F. Hoffmann-La Roche Ltd . Dr. Vassilaki has stock in Abbott Laboratories. Dr. Vassilaki has stock in Johnson and Johnson. Dr. Vassilaki has stock in Medtronic. Dr. Vassilaki has stock in Amgen. Dr. Vassilaki has stock in AbbVie. Dr. Vassilaki has stock in Merck. The institution of Dr. Vassilaki has received research support from NIH. The institution of Dr. Vassilaki has received research support from European Union/ St. Anne’s University Hospital Brno, Czech Republic. The institution of an immediate family member of Dr. Vassilaki has received research support from Avobis Bio, LLC.