P2-277: Prazosin for treatment of disruptive agitation in Alzheimer's disease

Abstract

component in studying AD. Not much is known about the effects of inclusion of lumbar punctures (LP) in clinical trials on the recruitment of participants, especially those who are asymptomatic. Evaluating recruitment efforts for trials with LPs is essential in determining if a protocol that includes CSF analysis can be accomplished. Objective: To discuss recruitment results for a clinical trial in which lumbar puncture procedures are part of study participation. Reasons for declining participation are described. Methods: Cognitively healthy, middle-aged adult children (ages 35-69) of persons with AD were contacted to participate in this 9 month clinical trial with 5-7 study visits. Study participation involves evaluating the effects of the study medication, simvastatin, on blood, CSF, MRI and cognitive biomarkers of AD. Individuals were recruited through the Wisconsin Registry for Alzheimer’s Prevention (WRAP) study, community outreach, memory clinics, internet postings, mailings, and newsletters. Chi-square tests were used to assess differences between groups. Re ults: Currently, 90 individuals of the targeted 100 have been enrolled. 108 individuals declined. Leading reasons for declining participation included the following: did not meet study inclusion criteria (n 43 [40%]); declined LP (n 18 [17%]); inconvenience (time and travel) (n 15 [14%]). The number of persons declining LP was significantly less than the number not meeting study inclusion criteria (p 0.0001), yet similar to the number of persons who did not want to participate due to the inconvenience (p 0.705). More women (n 74) than men (n 34) demonstrated interest in research (p 0.001). There were no differences in reasons for declining participation between women and men. Conclusions: Lumbar puncture procedures are not a significant barrier to successful recruitment of research participants into clinical trials aimed at studying biomarkers for AD prevention in asymptomatic adults at risk for disease. While women were more likely to express interest in participating in clinical trials, reasons for declining participation were similar between both groups of men and women.