Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-24T12:39:45.709Z Has data issue: false hasContentIssue false

29 - Alzheimer’s Disease Clinical Trial Study Partners

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Joshua Grill
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
Get access

Summary

Alzheimer’s disease (AD) clinical trials now include patients living with dementia, patients living with mild cognitive impairment or prodromal Alzheimer’s disease (AD), and patients with no cognitive impairment but biomarker evidence of preclinical disease. Each type of AD trial requires participants to enroll with a person they know well who can participate with them, a study partner. Study partners are essential to AD trial success. They are heavily involved in enrollment decisions, they are vital to trial protocol compliance, and they serve as informants for outcome measurements that are used to determine drug efficacy. This chapter reviews the essential role of study partners and the evidence available to instruct the field about how best to incorporate and potentially improve the design and conduct of trials as it relates to study partners.

Keywords

Caregiverpartnerinformantrecruitmentretentiondropout
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 333 - 342
Publisher: Cambridge University Press
Print publication year: 2022

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Hurd, MD, Martorell, P, Delavande, A, Mullen, KJ, Langa, KM. Monetary costs of dementia in the United States. N Engl J Med 2013; 368: 1326–34.Google Scholar
Largent, EA, Karlawish, J, Grill, JD. Study partners: essential collaborators in discovering treatments for Alzheimer’s disease. Alzheimers Res Ther 2018; 10: 101.Google Scholar
Knopman, DS. Clinical trial design issues in mild to moderate Alzheimer disease. Cogn Behav Neurol 2008; 21: 197–201.CrossRefGoogle ScholarPubMed
Grill, JD, Karlawish, J. Addressing the challenges to successful recruitment and retention in Alzheimer’s disease clinical trials. Alzheimers Res Ther 2010; 2: 34.Google Scholar
Schneider, LS, Olin, JT, Lyness, SA, Chui, HC. Eligibility of Alzheimer’s disease clinic patients for clinical trials. J Am Geriatr Soc 1997; 45: 923–8.Google Scholar
Karlawish, JH, Casarett, D, Klocinski, J, Sankar, P. How do AD patients and their caregivers decide whether to enroll in a clinical trial? Neurology 2001; 56: 789–92.Google Scholar
Karlawish, JH, Casarett, D, Propert, KJ, James, BD, Clark, CM. Relationship between Alzheimer’s disease severity and patient participation in decisions about their medical care. J Am Geriatr Soc Neurol 2002; 15: 68–72.Google Scholar
Cox, CG, Ryan, BAM, Gillen, DL, Grill, JD. preliminary, A study of clinical trial enrollment decisions among people with mild cognitive impairment and their study partners. Am J Geriatr Psychiatry 2019; 27: 322–32.CrossRefGoogle ScholarPubMed
Cox, CG, Ryan, MM, Gillen, D, Grill, JD. Is reluctance to share Alzheimer’s disease biomarker status with a study partner a barrier to preclinical trial recruitment? J Prev Alzheimers Dis 2021; 8: 52–8.Google Scholar
10. Karlawish, JH, Casarett, DJ, James, BD. Alzheimer’s disease patients’ and caregivers’ capacity, competency, and reasons to enroll in an early-phase Alzheimer’s disease clinical trial. J Am Geriatr Soc 2002; 50: 2019–24.CrossRefGoogle Scholar
Okonkwo, O, Griffith, HR, Belue, K, et al. Medical decision-making capacity in patients with mild cognitive impairment. Neurology 2007; 69: 1528–35.CrossRefGoogle ScholarPubMed
Jefferson, AL, Lambe, S, Moser, DJ, et al. Decisional capacity for research participation in individuals with mild cognitive impairment. J Am Geriatr Soc 2008; 56: 1236–43.Google Scholar
Okonkwo, OC, Griffith, HR, Copeland, JN, et al. Medical decision-making capacity in mild cognitive impairment: a 3-year longitudinal study. Neurology 2008; 71: 1474–80.CrossRefGoogle ScholarPubMed
National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The Prevention and Treatment of Missing Data in Clinical Trials. Washington, DC: National Academies Press; 2010.Google Scholar
Grill, JD, Kwon, J, Teylan, MA, et al. Retention of Alzheimer disease research participants. Alzheimer Dis Assoc Disord 2019; 33: 299–306.Google Scholar
Robinson, KA, Dinglas, VD, Sukrithan, V, et al. Updated systematic review identifies substantial number of retention strategies: using more strategies retains more study participants. J Clin Epidemiol 2015; 68: 1481–7.Google Scholar
Kozauer, N, Katz, R. Regulatory innovation and drug development for early-stage Alzheimer’s disease. N Engl J Med 2013; 368: 1169–71.CrossRefGoogle ScholarPubMed
Leber, P. Observations and suggestions on antidementia drug development. Alzheimer Dis Assoc Disord 1996; 10: 31–5.CrossRefGoogle ScholarPubMed
Amariglio, RE, Donohue, MC, Marshall, GA, et al. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer’s Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol 2015; 72: 446–54.CrossRefGoogle ScholarPubMed
Ryan, MM, Grill, JD, Gillen, DL, Alzheimer’s Disease Neuroimaging Initiative. Participant and study partner prediction and identification of cognitive impairment in preclinical Alzheimer’s disease: study partner vs. participant accuracy. Alzheimers Res Ther 2019; 11: 85.Google Scholar
Grill, JD, Karlawish, J. Study partners should be required in preclinical Alzheimer’s disease trials. Alzheimers Res Ther 2017; 9: 93.Google Scholar
Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimers Dement 2020; 16: 391–460.CrossRefGoogle Scholar
Grill, JD, Raman, R, Ernstrom, K, Aisen, P, Karlawish, J. Effect of study partner on the conduct of Alzheimer disease clinical trials. Neurology 2013; 80: 282–8.Google Scholar
Grill, JD, Raman, R, Ernstrom, K, et al. Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer’s disease clinical trials. Alzheimers Res Ther 2015; 7: 39.CrossRefGoogle ScholarPubMed
Grill, JD, Monsell, S, Karlawish, J. Are patients whose study partners are spouses more likely to be eligible for Alzheimer’s disease clinical trials? Dement Geriatr Cogn Disord 2012; 33: 334–40.CrossRefGoogle ScholarPubMed
Bernard, MA, Clayton, JA, Lauer, MS. Inclusion across the lifespan: NIH policy for clinical research. JAMA 2018; 320: 1535–6.Google Scholar
Conde-Sala, JL, Garre-Olmo, J, Turro-Garriga, O, Vilalta-Franch, J, Lopez-Pousa, S. Differential features of burden between spouse and adult-child caregivers of patients with Alzheimer’s disease: an exploratory comparative design. Int J Nurs Stud 2010; 47: 1262–73.CrossRefGoogle ScholarPubMed
Cary, MS, Rubright, JD, Grill, JD, Karlawish, J. Why are spousal caregivers more prevalent than nonspousal caregivers as study partners in AD dementia clinical trials? Alzheimer Dis Assoc Disord 2015; 29: 70–4.CrossRefGoogle ScholarPubMed
Zhou, Y, Elashoff, D, Kremen, S, et al. African Americans are less likely to enroll in preclinical Alzheimer’s disease clinical trials. Alzheimers Dement (N Y) 2017; 3: 57–64.CrossRefGoogle ScholarPubMed
Sperling, RA, Rentz, DM, Johnson, KA, et al. The A4 study: stopping AD before symptoms begin? Sci Transl Med 2014; 6: 228fs13.Google Scholar
Berstein, OM, Grill, JD, Gillen, DL. Recruitment and retention of participant and study partner dyads in two multinational Alzheimer’s disease registration trials. Alzheimers Res Ther 2021; 13: 16.Google Scholar
Edland, SD, Emond, JA, Aisen, PS, Petersen, RC. NIA-funded Alzheimer centers are more efficient than commercial clinical recruitment sites for conducting secondary prevention trials of dementia. Alzheimer Dis Assoc Disord 2010; 24: 159–64.Google Scholar
Conde-Sala, JL, Garre-Olmo, J, Turro-Garriga, O, Vilalta-Franch, J, Lopez-Pousa, S. Quality of life of patients with Alzheimer’s disease: differential perceptions between spouse and adult child caregivers. Dement Geriatr Cogn Disord 2010; 29: 97–108.Google Scholar
Grill, JD, Karlawish, J. Consider the source: the implications of informant type on outcome assessments. Alzheimer Dis Assoc Disord 2015; 29: 364.Google Scholar
Ready, RE, Ott, BR, Grace, J. Validity of informant reports about AD and MCI patients’ memory. Alzheimer Dis Assoc Disord 2004; 18: 11–16.Google Scholar
Cacchione, PZ, Powlishta, KK, Grant, EA, Buckles, VD, Morris, JC. Accuracy of collateral source reports in very mild to mild dementia of the Alzheimer type. J Am Geriatr Soc 2003; 51: 819–23.Google Scholar
Grill, JD, Zhou, Y, Karlawish, J, Elashoff, D. Frequency and impact of informant replacement in Alzheimer disease research. Alzheimer Dis Assoc Disord 2015; 29: 242–8.CrossRefGoogle ScholarPubMed
Nuno, MM, Gillen, DL, Grill, JD, et al. Study partner types and prediction of cognitive performance: implications to preclinical Alzheimer’s trials. Alzheimers Res Ther 2019; 11: 92.Google Scholar
Karlawish, J, Cary, MS, Rubright, J, Tenhave, T. How redesigning AD clinical trials might increase study partners’ willingness to participate. Neurology 2008; 71: 1883–8.CrossRefGoogle ScholarPubMed
Gelinas, L, Largent, EA, Cohen, IG, et al. Framework for ethical payment to research participants. N Engl J Med 2018; 378: 766–71.CrossRefGoogle ScholarPubMed

Save book to Kindle

To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×