Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials

Annalise Rahman-Filipiak^{1

2}, Corey Bolton^{3

4}, Joshua D Grill⁵, Ayda Rostamzadeh⁶, Nathaniel Chin^{7

8}, Judith Heidebrink^{2

9}, Sarah Getz¹⁰, Nicole R Fowler^{11

12}, Allyson Rosen^{13

14}, Jennifer Lingler^{15

16}, Ellen Wijsman¹⁷, Lindsay Clark^{8

18}; Advisory Group on Risk Evidence Education in Dementia (AGREED)

Affiliations

¹ Research Program on Cognition & Neuromodulation Based Interventions, University of Michigan, Ann Arbor, Michigan, USA.
² Michigan Alzheimer's Disease Research Center, University of Michigan, Ann Arbor, Michigan, USA.
³ Vanderbilt Memory and Alzheimer's Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁴ Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁵ Departments of Psychiatry and Human Behavior and Neurobiology and Behavior, Institute for Memory Impairments and Neurological Disorders, University of California Irvine, Irvine, California, USA.
⁶ Department of Psychiatry and Psychotherapy, Center for Memory Disorders, Faculty of Medicine and University Hospital, University of Cologne, Albertus-Magnus-Platz, Germany.
⁷ Wisconsin Alzheimer's Disease Research Center, Madison, Wisconsin, USA.
⁸ Department of Medicine, Division of Geriatrics & Gerontology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
⁹ Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
¹⁰ Department of Neurology, University of Miami School of Medicine, Miami, Florida, USA.
¹¹ Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
¹² Indiana University Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana, USA.
¹³ Palo Alto Veterans Affairs Medical Center, Palo Alto, California, USA.
¹⁴ School of Medicine, Stanford University, Stanford, California, USA.
¹⁵ Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania, USA.
¹⁶ University of Pittsburgh Alzheimer's Disease Research Center, UPMC Montefiore, Pittsburgh, Pennsylvania, USA.
¹⁷ Division of Medical Genetics, Department of Medicine and Department of Biostatistics, University of Washington, Seattle, Washington, USA.
¹⁸ Geriatric Research Education and Clinical Center, William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin, USA.

PMID: 37450489
PMCID: PMC10530125
DOI: 10.1002/alz.13380

Review

Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials

Annalise Rahman-Filipiak et al. Alzheimers Dement. 2023 Sep.

. 2023 Sep;19(9):4270-4275.

doi: 10.1002/alz.13380. Epub 2023 Jul 14.

Authors

Affiliations

¹ Research Program on Cognition & Neuromodulation Based Interventions, University of Michigan, Ann Arbor, Michigan, USA.
² Michigan Alzheimer's Disease Research Center, University of Michigan, Ann Arbor, Michigan, USA.
³ Vanderbilt Memory and Alzheimer's Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁴ Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁵ Departments of Psychiatry and Human Behavior and Neurobiology and Behavior, Institute for Memory Impairments and Neurological Disorders, University of California Irvine, Irvine, California, USA.
⁶ Department of Psychiatry and Psychotherapy, Center for Memory Disorders, Faculty of Medicine and University Hospital, University of Cologne, Albertus-Magnus-Platz, Germany.
⁷ Wisconsin Alzheimer's Disease Research Center, Madison, Wisconsin, USA.
⁸ Department of Medicine, Division of Geriatrics & Gerontology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
⁹ Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
¹⁰ Department of Neurology, University of Miami School of Medicine, Miami, Florida, USA.
¹¹ Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
¹² Indiana University Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana, USA.
¹³ Palo Alto Veterans Affairs Medical Center, Palo Alto, California, USA.
¹⁴ School of Medicine, Stanford University, Stanford, California, USA.
¹⁵ Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania, USA.
¹⁶ University of Pittsburgh Alzheimer's Disease Research Center, UPMC Montefiore, Pittsburgh, Pennsylvania, USA.
¹⁷ Division of Medical Genetics, Department of Medicine and Department of Biostatistics, University of Washington, Seattle, Washington, USA.
¹⁸ Geriatric Research Education and Clinical Center, William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin, USA.

PMID: 37450489
PMCID: PMC10530125
DOI: 10.1002/alz.13380

Abstract

Introduction: The development of biomarkers for Alzheimer's disease (AD) has allowed researchers to increase sample homogeneity and test candidate treatments earlier in the disease. The integration of biomarker "screening" criteria should be met with a parallel implementation of standardized methods to disclose biomarker testing results to research participants; however, the extent to which protocolized disclosure occurs in trials is unknown.

Methods: We reviewed the literature to identify prodromal AD trials published in the past 10 years. From these, we quantified the frequency of biomarker disclosure reporting and the depth of descriptions provided.

Results: Of 30 published trials using positron emission tomography or cerebrospinal fluid-based amyloid positivity as an eligibility criterion, only one mentioned disclosure, with no details on methods.

Discussion: Possible reasons for and implications of this information gap are discussed. Recommendations are provided for trialists considering biomarker screening as part of intervention trials focused on prodromal AD.

Highlights: Few prodromal Alzheimer's disease (AD) trial papers discuss biomarker disclosure. Disclosure has implications for participants, family members, and trial success. Disclosure must be consistently integrated and reported in prodromal AD trials. Best practice guidelines and training resources for disclosure are needed.

Keywords: amyloid; biomarker disclosure; mild cognitive impairment; prodromal Alzheimer's disease; randomized controlled trials.

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Figures

**Figure 1.**
PRISMA Diagram of Literature Review.

See this image and copyright information in PMC

References

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Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials

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Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials

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