Reduced memory and executive functioning significantly relates to participation in early phase clinical research in Alzheimer's disease: Human/Trial design. (7th December 2020)

• Record Type: Journal Article
• Authors: Park, Lovingly; Gertsik, Lev; Mendoza, Zyanya; Morris, Lydia; Aguilar, Claudia; Sherman, Molly; Semenova, Svetlana; Jhee, Stanford
• Is Part Of: Alzheimer's & dementia. Volume 16(2020)Supplement 9
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-12-07
• Subjects: Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.046277
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Background: The patient's decision to enroll in clinical research is hampered by level of impairment, the need for a study partner, inclusion/exclusion criteria as well as factors related to the study design and trial procedures. These are exacerbated in early phase since the objectives center on safety and tolerability, without explicit benefit for the patient to participate. With the scientific advancements in AD, the protocols are increasingly complex with procedures involving CSF, pharmacokinetic sampling, and clinical endpoints. This study delineates the degree to which cognition may influence a patient's decision to participate in clinical research. Method: Patients were recruited a memory clinic at Parexel Early Phase Clinical Research Unit. Referrals come from their treating physicians, community outreach, and the research programs if there is a need for a diagnostic evaluation prior to their screening visits. We included a sample of healthy older adults (HNE; n=37, age=65.46, education=15.05), Mild Cognitive Impairment (MCI; n=54; age= 70.78, education= 14.20), AD (n=75, age=77.37, education=13.27), and other neurologic conditions (n=16; age=62.38; education=12.86). A binary logistic regression was used, with interested and not interested in research participation as the DV. The RBANS served as the index for cognition, COWAT and TMT B were the indices for executive functioning. Patients were provided descriptions of the types of procedures involved and a summary of the risks and benefits of participating, before they were asked about their interest in participation. Result: There were differences in cognition across all diagnostic groups with the healthy elderly performing better across all tests than the others (p<.05) and they were also more likely to participate than others. Results of the logistic regression showed that the relationships among list learning (χ 2 =4.97, p<.05), recognition (χ 2 =8.03, p<.05), and letter fluency (χ 2 =4.11, p<.05) were significantly related to participation. Conclusion: Findings show that cognition, particularly in initial learning and executive functioning, predicts whether patient's decision to participate. This is not surprising given the complexity of the information presented to the patient that are associated with most early phase research studies. Careful and tailored conversations about research studies are needed to facilitate recruitment.