Managing an Alzheimer’s Disease Study With Complex Assessments

Premier Research managed a double-blind, randomized pilot study to evaluate the effects of the investigational product versus a comparator on sleep and attention and gastrointestinal tolerance in patients with mild to moderate Alzheimer’s disease for a global pharmaceutical company. Eight investigative sites conducted the trial that enrolled 90 patients with 65 of the patients completing the study.

This study included multiple complex assessments including trial eligibility (neurological examination, CT/MRI scan and Mini-Mental State Examination as well as medical and personal history), voluntary genetic analysis of DNA sample, sleep (Actigraphy, Sleep Logs and Pittsburgh Sleep Quality Index), attention (Choice Reaction Time/ Simple Reaction Time, Verbal Series Attention Tests and Stroop Test) in addition to other efficacy measures.

Premier Research took steps to ensure the standardization of the outcome assessments including the recruitment of experienced sites, rater training during investigator meetings, and documentation of site staff qualifications and training.

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