Using AD Biomarker Research Results for Clinical Care

A Survey of ADNI Investigators

2008-05_Tully_RWJF_GFH-471

This article examines investigators' opinions on changing the Alzheimer’s Disease Neuroimaging Initiative (ADNI) policy and disclosing ADNI biomarker information to research participants.

The Issue:

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) gathers medical data researchers use for clinical research. Currently, ADNI policy states that research results not be returned to ADNI participants. In April 2012, the Food and Drug Administration (FDA) approved the amyloid-binding radiotracer florbetapir. Given this approval, this article examines investigators' opinions on changing the ADNI policy and disclosing ADNI biomarker information to research participants.

While a majority support disclosure of amyloid, ADNI investigators need guidance on how to return results and monitor the disclosure process.

Key Findings

  • Among ADNI investigators, 90 percent do not return amyloid imaging results to ADNI participants.

  • Seventy-three percent of ANDI researchers overall definitely or probably support disclosure of amyloid imaging information to participants with mild cognitive impairment.

  • However, 58 percent definitely or probably support disclosure to participants with normal cognition.

Conclusion:

Current guidelines for returning research results in genomic studies often focuses on protecting patients, but trends are changing. The findings above suggest that ADNI policy may first want to address those with mild cognitive impairment. ADNI investigators need guidance on how to return results and monitor the disclosure process. Additionally, research is required on understanding the value of returning results. This study provides important information as ADNI assesses its policy.

About the Study:

All ADNI investigators and personnel were invited to complete an anonymous online survey. Questions were both fixed choice and free-text questions. Data collection took place between March 2012 and April 2012. A total of 159 individuals responded (52% overall response rate).

More from Robert Wood Johnson Foundation Health & Society Scholars

To build the field of population health by training scholars to investigate the connections among biological, behavioral, environmental, economic, and social determinants of health and develop policies to improve health and reduce disparities in health.

More from Robert Wood Johnson Foundation Health & Society Scholars