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. 2019 Mar;27(3):322-332.
doi: 10.1016/j.jagp.2018.10.016. Epub 2018 Nov 3.

A Preliminary Study of Clinical Trial Enrollment Decisions Among People With Mild Cognitive Impairment and Their Study Partners

Chelsea G Cox  1 , Mary M Ryan B A  2 , Daniel L Gillen  3 , Joshua D Grill  4
Affiliations

A Preliminary Study of Clinical Trial Enrollment Decisions Among People With Mild Cognitive Impairment and Their Study Partners

Chelsea G Cox et al. Am J Geriatr Psychiatry. 2019 Mar.

Abstract

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.

Keywords: Recruitment; clinical trials; prodromal Alzheimer disease.

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Conflict of interest statement

Conflicts of interest disclosures

Ms. Cox has nothing to disclose.

Ms. Ryan has nothing to disclose.

Dr. Gillen has nothing to disclose.

Figures

Figure 1.
Figure 1.
Participant responses when asked how the dyad would decide whether to enroll in a clinical trial.
Figure 2.
Figure 2.
The proportion of patients (A) and study partners (B) responding they would be “extremely likely” to participate in trial vignettes of three different risk strata, dependent upon whether the trial did not (MCI trial) or did (Prodromal AD trial) enroll only individuals meeting amyloid PET biomarker inclusion criteria.
See this image and copyright information in PMC

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