Skip to main content Accessibility help
×
Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-24T00:06:22.509Z Has data issue: false hasContentIssue false

14 - Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

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

The path to approvability of drugs created for Alzheimer’s disease (AD) dementia, mild cognitive impairment, or associated symptoms of AD is long and expensive, involving the study sponsor, the registration authorities, a clinical research organization, and the performance site. The key to successful AD trials is the performance site, the individual investigators, the recruited subjects, and the quality of the data generated. Performance sites include academic medical centers, a division within a large multi-specialty group, and for-profit clinical trial companies. All performance sites have common elements. These include the staff (investigator, coordinator, rater/neuropsychologist, and manager), access to study participants for enrollment, appropriate training of staff, regulatory oversight (investigational review board ), and the ancillary services. Types of studies that are available include therapeutic (medication or device), longitudinal observational, and imaging. Different types of studies have different requirements for staff or infrastructure, some easy to deploy, others not. In this chapter we will describe the elements of a successful AD clinical trial site.

Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
, pp. 170 - 176
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

Oxford, AE, Stewart, ES, Rohn, TT. Clinical trials in Alzheimer’s disease: a hurdle in the path of remedy. Int J Alzheimers Dis 2020; 2020: 5380346.Google ScholarPubMed
Cummings, J, Lee, G, Ritter, A, Sabbagh, M, Zhong, K. Alzheimer’s disease drug-development pipeline: 2020. Alzheimer Dement (N Y) 2020; 6: e12050.Google Scholar
Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimers Dement 2020; 16: 391460.Google Scholar
Morris, J. Clinical Dementia Rating: a reliable and valid diagnostic and staging measure for dementia of the Alzheimer type. Int Psychogeriatr 1997; 9: 173–6.CrossRefGoogle ScholarPubMed
Schneider, LS, Olin, JT, Doody, RS, et al. Validity and reliability of the Alzheimer’s Disease Cooperative Study–Clinical Global Impression of Change. The Alzheimer’s Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997; 11: S2232.CrossRefGoogle ScholarPubMed
Reisberg, B, Ferris, SH, de Leon, MJ, Crook, T. The global deterioration scale for assessment of primary degenerative dementia. Am J Psychiatry 1982; 139: 1135–9.Google Scholar
Rosen, WG, Mohs, RC, Davis, KL. A new rating scale for Alzheimer’s disease. Am J Psychiatry 1984; 141: 1356–64.Google Scholar
Monsch, AU, Bondi, MW, Salmon, DP, et al. Clinical validity of the Mattis Dementia Rating Scale in detecting dementia of the Alzheimer type. A double cross-validation and application to a community-dwelling sample. Arch Neurol 1995; 52: 899904.CrossRefGoogle ScholarPubMed
Panisset, M, Roudier, M, Saxton, J, Boller, F. Severe Impairment Battery. A neuropsychological test for severely demented patients. Arch Neurol 1994; 51: 41–5.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
×