VAN DIJKEN, MILOU (2024) How to improve prescreening activities to lower screen failure rates in clinical trials in Alzheimer disease at Brain Research Center. thesis, Medicine.
Full text available on request.Abstract
Background: Alzheimer Disease (AD) is the most prevalent form of dementia however currently no AD modifying drugs are on the market in Europe. Clinical trials involving AD patients are costs and time consuming due to high screen failure (SF) rates (44%). Brain Research Center (BRC) conducts clinical trials targeting brain diseases with a dominant focus on AD. BRC uses medical files from participants to conduct a prescreening in which participants get excluded or matched with trials as a tool to prevent SFs. This study investigates the prescreening and screening data of BRC participants to enhance the prescreening process in clinical trials targeting AD and to lower SF rates. Methods: Data from 171 participants with AD who were screened for a clinical trial at BRC were collected from medical files and study files . SF counts and reasons were analyzed. The cohort was divided in a screening ‘pass’ and ‘fail’ group to compare the clinical and demographic characteristics of the participants. Results: The SF rate in this cohort is 34,4%, with the most frequent SF reasons being cognitive testing scores (36,9%) and amyloid-β/tau status (29,8%). Participant characteristics associated with SF included male sex (p=0.05), negative amyloid-β status (p=0.02), diabetes prevalence (p=0.01), malignancy prevalence (p=0.03) and cholinesterase inhibitors use (p=0.01). Conclusion: Prescreening in AD clinical trials is a valuable tool to prevent high SF rates. During prescreening and screening attention should be given mainly to the Mini Mental State Exam score and the amyloid-β and tau protein status.
| Item Type: | Thesis (UNSPECIFIED) |
|---|---|
| Supervisor name: | Prof. Dr. van Munster, B. C. and Dr. Prins, S. |
| Faculty: | Medical Sciences |
| Date Deposited: | 09 Sep 2024 12:40 |
| Last Modified: | 09 Sep 2024 12:40 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/3754 |
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