Abstract Details

Title Eligibility for the Donanemab Trial in a Population-Based Study of Cognitive Aging

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) N4 - Neuroscience in the Clinic: Alzheimer's Disease Biomarker Testing and Amyloid Monoclonals in Clinical Practice (1:40 PM-1:50 PM)

Poster/Presentation
Number 001

Objective To examine eligibility to receive donanemab treatment in a population-based study of cognitive aging.

Background We recently demonstrated that applying clinical trial inclusion and exclusion criteria to the population-based Mayo Clinic Study of Aging (MCSA) participants would exclude most patients with early Alzheimer’s disease (AD) from qualifying for lecanemab and aducanumab treatment. In a more recent clinical trial, donanemab was found to slow the rate of decline in early AD, but selection criteria uniquely also included a tau PET assessment to help identify optimal candidates. The proportion of patients with early symptomatic AD eligible for donanemab trial in a community-based setting is unknown.

Design/Methods 817 MCSA participants (aged 60-85 years) were clinically diagnosed with MCI or mild AD dementia. Donanemab eligibility criteria were further applied to this sample and tau PET positivity was visually assessed.

Results 782 (96% of 817) participants had an MMSE score between 20-28 and 13 had MRI/PET contraindications, leaving 769 participants meeting the inclusion criteria before any PET scan. 275 participants had amyloid PET available, of whom 130 also had a tau PET at the same visit; 56 (43% of 130) patients were determined to be amyloid positive (A+), and of those, 27 were determined to be tau positive (T+) as well, based on visual assessment. Exclusion criteria from the trial (e.g., central nervous system-related exclusions, history of malignancy, neuroimaging findings) further reduced the eligible population to 13 (23% of 56).

Conclusions The percentage of individuals with early symptomatic AD who potentially qualify for anti-amyloid trials remains limited.

Authors/Disclosures
Katherine Jones PRESENTER	No disclosure on file
Jeremiah Aakre, MPH	Mr. Aakre has nothing to disclose.
Anna Castillo	Anna Castillo has nothing to disclose.
Vijay K. Ramanan, MD, PhD (Mayo Clinic)	The institution of Dr. Ramanan has received research support from the National Institutes of Health. The institution of Dr. Ramanan has received research support from the Mangurian Foundation for Lewy Body Disease Research. The institution of Dr. Ramanan has received research support from as part of clinical trials sponsored by the Alzheimer's Association, Eisai, the Alzheimer's Treatment and Research Institute at USC, and Transposon Therapeutics, Inc.. The institution of Dr. Ramanan has received research support from Medscape. The institution of Dr. Ramanan has received research support from Expert Perspectives in Medicine. Dr. Ramanan has received personal compensation in the range of $500-$4,999 for serving as a Conference Speaker/Organizer (Honoraria) with AANI.
Walter Kremers	The institution of Walter Kremers has received research support from NIH. The institution of an immediate family member of Walter Kremers has received research support from NIH.
Clifford R. Jack, Jr., MD (Mayo Clinic)	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.
Prashanthi Vemuri, PhD (Mayo Clinic)	The institution of Dr. Vemuri has received research support from NIH.
Val J. Lowe, MD (Mayo Clinic)	Dr. Lowe has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AVID Radiopharmaceutical. Dr. Lowe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Inc. The institution of Dr. Lowe has received research support from AVID Radiopharmaceuticals.
David S. Knopman, MD, FAAN (Mayo Clinic)	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.
Ronald C. Petersen, MD, PhD, FAAN (Mayo Clinic)	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 Genentech. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly and Co.. Dr. Petersen has received personal compensation in the range of $0-$499 for serving as a Consultant for Eisai, Inc.. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. 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. Petersen has received publishing royalties from a publication relating to health care. Dr. Petersen has a non-compensated relationship as a Board of Directors with American Brain Foundation that is relevant to AAN interests or activities.
Maria Vassilaki, MD, PhD (Mayo Clinic, Department of Quantitative Health Sciences)	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.
Jonathan Graff-Radford, MD, FAAN	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 $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JAMA Neurology. The institution of Dr. Graff-Radford has received research support from NIH. The institution of Dr. Graff-Radford has received research support from Eisai. The institution of Dr. Graff-Radford has received research support from Cognition therapeutics.

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