Journal
AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
Volume 27, Issue 3, Pages 322-332Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jagp.2018.10.016
Keywords
Recruitment; clinical trials; prodromal Alzheimer disease
Categories
Funding
- National Institute on Aging pilot grant from the University of California, Irvine, Alzheimer's Disease Research Center [AG016573]
- National Institute on Aging [AG000096]
- Biogen Idec
- Eli Lilly and Company
- Genentech
- Alzheimer's Disease Cooperative Study
- Alzheimer's Therapeutic Research Institute
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Objective: All Alzheimer disease (AD) clinical trials, including those enrolling patients with mild cognitive impairment (MCI), require dyadic participation. The purpose of this study was to elucidate how people with MCI and their study partners decide whether to enroll in clinical trials. Methods: This was a mixed methods interview study. We interviewed patient participants with a consensus research diagnosis of MCI and their study partners. Interviews examined how dyads decide whether to enroll in a clinical trial and whether AD biomarker testing affects willingness to enroll. Results: Though most MCI patients and study partners would decide in partnership whether to enroll in a clinical trial, agreement was lower among nonspousal, compared with spousal, dyads. Deterrents to enrollment included concerns about patient safety and inconvenience, especially for study partners. Motivators to enrollment included altruism, the desire to contribute to research, hope for patient benefit, and the desire to learn more about the patient's condition. When asked open-ended questions about motivators to enroll in trials, few patients cited access to biomarker testing specifically, though most expressed a desire to undergo biomarker testing when asked directly. Conclusion: Spousal and nonspousal MCI dyads may approach clinical trial decisions differently. Future research should investigate how AD biomarker testing affects participants' willingness to enroll in trials.
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