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Clinical Trial
. 2025 Apr;12(4):100088.
doi: 10.1016/j.tjpad.2025.100088. Epub 2025 Feb 17.

Eligibility for donanemab trial in a population-based study of cognitive aging

Katherine E Jones  1 , Jeremiah A Aakre  2 , Anna M Castillo  2 , Vijay K Ramanan  3 , Walter K Kremers  2 , Clifford R Jack Jr  4 , Prashanthi Vemuri  4 , Christopher G Schwarz  4 , Val J Lowe  4 , David S Knopman  3 , Ronald C Petersen  3 , Jonathan Graff-Radford  3 , Maria Vassilaki  5
Affiliations
Clinical Trial

Eligibility for donanemab trial in a population-based study of cognitive aging

Katherine E Jones et al. J Prev Alzheimers Dis. 2025 Apr.

Abstract

The study aimed to assess eligibility for donanemab phase 3 trial in participants of the Mayo Clinic Study of Aging with mild cognitive impairment (MCI) or mild dementia consistent with Alzheimer's disease (AD) clinical syndrome, positive brain amyloid burden, and available tau PET. There were 817 study participants, 60-85 years old, with MCI or dementia consistent with AD clinical syndrome. Applying the Mini-Mental State Examination criteria (20 to 28) and excluding participants with imaging contraindications reduced the sample to 769; 275 participants had amyloid PET available, of whom 130 had also tau PET at the same visit; 56 participants were amyloid positive, had tau PET available at the same visit, and of those, 27 had evidence of tau pathology measured by 18F-flortaucipir PET imaging. Additional eligibility criteria reduced the eligible participants to 23 % (13 out of 56 participants). Neuroimaging findings, central nervous system exclusions, and history of malignancy were the major exclusions.

Keywords: Clinical trials; Donanemab; Eligibility.

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Conflict of interest statement

Declaration of interests The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Maria Vassilaki, Vijay K. Ramanan, Walter K. Kremers, Clifford R. Jack Jr, David S. Knopman, Prashanthi Vemuri, Christopher G Schwarz, Val J. Lowe, Ronald C. Petersen reports financial support was provided by National Institutes of Health. Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, enabled use of the 18F-flortaucipir tracer by providing precursor, but did not provide direct funding and was not involved in data analysis or interpretation. Vijay K. Ramanan has received research funding from the NIH and the Mangurian Foundation for Lewy Body disease research, has provided educational content for Medscape, has received speaker and conference session honoraria from the American Academy of Neurology Institute, is co-PI for a clinical trial supported by the Alzheimer's Association, is site Co-I for the Alzheimer's Clinical Trials Consortium, and is a site clinician for clinical trials supported by Eisai, the Alzheimer's Treatment and Research Institute at USC, and Transposon Therapeutics, Inc. Walter K. Kremers receives research funding from NIH. Clifford R. Jack Jr. has no financial conflicts to disclose; he receives research support from NIH and the Alexander Family Alzheimer's Disease Research Professorship of the Mayo Clinic. David S. Knopman serves on a Data Safety Monitoring Board for the Dominantly Inherited Alzheimer Network Treatment Unit study sponsored by Washington University St Louis, and for the SMART-HS clinical trial (Univ of Kentucky). He was an investigator in Alzheimer clinical trials sponsored by Biogen, Lilly Pharmaceuticals and the University of Southern California, both of which have ended, and is currently an investigator in a trial in frontotemporal degeneration with Alector. He has served as a consultant for Roche, AriBio, Linus Health, Biovie and Alzeca Biosciences but receives no personal compensation. He receives funding from the NIH. Prashanthi Vemuri receives research funding from NIH. Christopher G Schwarz receives research funding from the NIH. Val J. Lowe serves as a consultant for Bayer Schering Pharma, Piramal Life Sciences, Life Molecular Imaging, Eisai Inc., AVID Radiopharmaceuticals, and Merck Research, and receives research support from GE Healthcare, Siemens Molecular Imaging, AVID Radiopharmaceuticals, and the NIH (NIA, NCI). Ronald C. Petersen serves as a consultant for Roche, Inc., Genentech, Inc., Eli Lilly and Co., Novo Nordisk, Eisai, Inc. (no funding), receives royalties from Oxford University Press and UpToDate, contributes to Medscape education and receives NIH funding. Jonathan Graff-Radford receives support from the NIH and serves on the DSMB for StrokeNET and is an investigator in clinical trials sponsored by Esai, Cognition therapeutics, and the Alzheimer's Treatment and Research Institute at USC. Maria Vassilaki consulted for F. Hoffmann-La Roche Ltd, unrelated to the current study; she receives research funding from NIH and has equity ownership in Amgen and Johnson and Johnson. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig 1
Fig. 1
Eligibility criteria for the donanemab trial. *We excluded patients who were clinically diagnosed with the following: hard-to-classify dementia (1 person), vascular dementia via NINDS-AIREN criteria (2 people), Parkinson's disease (4 people), stroke (10 people), multiple infarctions (3 people), subarachnoid hemorrhage (1 person), subdural hematoma (1 person), alcohol use disorder (1 person), prior intellectual disability (1 person), and other metabolic or toxic disorder (1 person). §We also verified that patients did not have these diagnoses at the clinical assessment: Lewy body dementia, frontotemporal dementia, intracerebral hemorrhage, drug-related psychiatric diagnosis, Binswanger's disease, progressive supranuclear palsy, and multiple sclerosis. **Contraindications were: pacemaker (9 people), QTc score out of range (2 people), craniotomy (1 person), failed metal screening (1 person).
See this image and copyright information in PMC

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