P3-302: Recruitment of people with amnestic mild cognitive impairment for an exercise study

Recruitment of healthy controls and Amnestic Mild Cognitive Impairment (aMCI) patients, a prodromal stage of Alzheimer's disease (AD), to participate in clinical trials is essential for research and testing the efficacy of potential pharmacological or nonpharmacological interventions for AD. However, significant challenges present in recruitment of subjects in these studies. We reported herein our experience of recruiting aMCI patients for a year-long exercise training study (ClinicalTrials.gov, CT01146717). Participants were recruited from the Dallas-Fort Worth Metroplex, the fourth-largest metropolitan area in the US. Recruitment materials advertised for men and women between the ages of 55–80 with subjective memory complaints who did no more than 90 minutes of aerobic exercise per week and were without uncontrolled hypertension, diabetes, obesity and any other major medical problems. Screening for aMCI is based on the revised Petersen criteria. Potential subjects must be willing and able to commit to a 12-month exercise or stretching program. A recruiter gave talks, passed out fliers and advertised in well-known local newspapers. Two symposiums were conducted aimed at informing the local community on the aging brain and AD. The presentation showed results between 02/2010 and 02/2013. A total of 976 people were screened by telephone. 810 were excluded based on the inclusion/exclusion criteria. An additional 91 subjects were excluded after a clinical visit for further screening. The 3 top reasons for exclusion by telephone are: 1) medical issues commonly seen in the aging population (256); 2) not interested/available after learning more about the study (203); 3) exercise history (158). The 3 top reasons for exclusion after a clinical visit are: 1) memory screen fail using revised Petersen criteria (44); 2) not interested/available (21); 3) medical issues (16). Only 8% of the contacted population (30 controls and 45 aMCI) were enrolled in the study. The age-related comorbidities were the main reason for the exclusion of potential subjects in this exercise study in sedentary but otherwise healthy aMCI patients. Future interventional studies need to consider the age-related comorbidities in aMCI patients.