Using AD biomarker research results for clinical care: a survey of ADNI investigators

Abstract

Objective: To inform whether the Alzheimer's Disease Neuroimaging Initiative (ADNI) should change its policy of not returning research results to ADNI participants, we surveyed investigators and research staff about disclosing ADNI biomarker information to research participants, with particular emphasis on amyloid imaging results.

Methods: In April 2012, just before Food and Drug Administration approval of the amyloid-binding radiotracer, florbetapir, all ADNI investigators and personnel were recruited to complete an anonymous online survey that contained fixed choice and free-text questions.

Results: Although ADNI participants often requested amyloid imaging results (the proportions of investigators who reported requests from more than half of their participants with normal cognition or mild cognitive impairment were 20% and 22%, respectively), across all diagnostic groups, the majority of ADNI investigators (approximately 90%) did not return amyloid imaging results to ADNI participants. However, the majority of investigators reported that, if the Food and Drug Administration approved florbetapir, they would support the return of amyloid imaging results to participants with mild cognitive impairment and normal cognition, but they emphasized the need for guidance on how to provide these results to participants and for research to assess the value of returning results as well as how returning results will affect study validity and participant well-being.

Conclusions: A majority of ADNI investigators support returning amyloid imaging results to ADNI participants. The findings that they want guidance on how to do this and research on the impact of disclosure suggest how to develop and monitor a disclosure process.

Figure. Proportion of physicians with direct participant contact (n = 62) reporting that measures provide clinically meaningful information

*Proportion of respondents rating GDS as clinically meaningful in persons with normal cognition was significantly different (McNemar exact test, p = 0.01) compared with amyloid imaging. Proportion of respondents rating CDR and MMSE as clinically meaningful in persons with AD dementia was significantly different (McNemar exact test, p = 0.04, p < 0.001) compared with amyloid imaging. **Amyloid imaging was more likely to be rated as providing clinically meaningful information for persons with mild cognitive impairment (52/62, 84%) than for persons with normal cognition (39/62, 63%, McNemar exact test, p < 0.001) or AD dementia (45/62, 73%, McNemar exact test, p = 0.02). ***n = 61 for physicians reporting on clinical value of FDG-PET in persons with AD dementia. AD = Alzheimer disease; CDR = Clinical Dementia Rating; FDG = [¹⁸F]-fluorodeoxyglucose; GDS = Geriatric Depression Scale; MMSE = Mini-Mental State Examination.